Study of Chokeberry to Reduce Cardiovascular Disease Risk in Former Smokers
Study Details
Study Description
Brief Summary
The purpose of this project is to determine whether chokeberry polyphenols mitigate cardiovascular disease risk in former smokers.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
More than 31% of Connecticut adults are former smokers, which may contribute to the high cardiovascular disease (CVD) risk in this state. Atherosclerosis, a hallmark of CVD, is a progressive life-long process. Chronic cigarette smoking increases atherosclerosis and CVD risk. While smoking cessation may lower CVD risk, former smokers still are at high CVD risk. The mechanisms by which smoking accelerates atherosclerosis formation are not fully understood. This knowledge gap prevents development of informed interventions to reduce CVD risk in former smokers.
Previous work suggests smoking increases oxidative stress and leads to elevated CVD risk. Former smokers also have decreased antioxidants and markers of vascular function in the circulation, suggesting that despite cessation, smoking has a lingering adverse effect on CVD protective mechanisms. Chokeberry (Aronia melanocarpa) is a native Connecticut plant rich in polyphenol antioxidants and is a promising intervention for reducing CVD risk in former smokers. Chokeberries have diverse polyphenols such as anthocyanins, proanthocyanidins, resveratrol, quercetin, and chlorogenic acid. Chokeberry consumption improves dyslipidemia, inhibits inflammation, and reduces oxidative stress in humans and animals, all of which could contribute to the prevention of CVD in former smokers. Therefore, our central hypothesis is that dietary chokeberry polyphenols reduce CVD risk in former smokers by improving lipid profiles and inhibiting inflammation and oxidative stress. Our long-term goal is to define the mechanisms by which polyphenol antioxidants mitigate CVD risk. The overall goal of this project is to conduct a randomized placebo-controlled clinical trial to evaluate the cardio-protective effects of dietary chokeberry polyphenols in former smokers.
Our objectives are to determine 1) the effect of chokeberry polyphenols on plasma cholesterol and triglyceride levels and on gene expression involved in cholesterol metabolism; 2) the extent to which chokeberry improves antioxidant and vascular function in former smokers; and 3) the association of bioavailability of chokeberry polyphenols to changes in biomarkers of CVD risk.
Successful completion of this work will result in improved understanding of the role of dietary berry polyphenols to regulate lipid metabolism, inflammation and oxidative stress. Thus, this study will be an important step to developing dietary recommendations for individuals predisposed to CVD risk, particularly former smokers.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Placebo Comparator: Color-matched rice powder pill Color-matched rice powder pill |
Dietary Supplement: Placebo capsule
Color-matched rice powder pill, 2 x 250 mg/day for 12 weeks
|
| Active Comparator: Chokeberry extract capsule Chokeberry extract capsule |
Dietary Supplement: Chokeberry Extract
Consumption of 2 x 250 mg chokeberry extract capsules daily for 12 weeks.
|
| Experimental: Chokeberry extract capsule (acute) Chokeberry extract capsule pharmacokinetics |
Dietary Supplement: Chokeberry extract capsule, acute
Chokeberry extract capsule, 2 x 250 mg, one-time dose.
|
Outcome Measures
Primary Outcome Measures
- LDL Cholesterol [Baseline, 6 weeks, 12 weeks of intervention]
Change in LDL cholesterol from baseline after chronic supplementation. Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose.
Secondary Outcome Measures
- Total Cholesterol [6 and 12 weeks after supplementation]
Change in fasting total cholesterol from baseline after chronic supplementation. Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose.
- HDL-cholesterol [6 and 12 weeks after supplementation]
Change in fasting plasma cholesterol from baseline after chronic supplemenation. Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose.
- Triglycerides [6 and 12 weeks after supplementation]
Change in fasting plasma triglycerides from baseline after chronic supplementation. Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose.
- Resting Systolic Blood Pressure [Baseline, 6 weeks, and 12 weeks following intervention]
Change in resting systolic blood pressure after chronic supplementation. Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose.
- Resting Diastolic Blood Pressure [Baseline, 6 weeks, and 12 weeks following intervention]
Change in resting diastolic blood pressure after chronic supplementation. Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose.
- Urinary F2-isoprostanes [Baseline and 12 weeks following intervention]
Change in resting urinary F2-isoprostanes after chronic supplementation. Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose.
- 3-hydroxy-3-methyl-glutaryl Coenzyme A Reductase (HMGR) [Baseline, 12 wk]
Monocyte messenger ribonucleic acid (mRNA) expression normalized to glyceraldehyde-3-phosphate dehydrogenase (GAPDH) after chronic supplementation. Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose.
- LDL Receptor (LDLR) [Change from baseline at 12 weeks]
Monocyte LDL receptor mRNA normalized to glyceraldehyde-3-phosphate dehydrogenase after chronic supplementation. Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose.
- LDL Receptor (LDLR) Protein [Baseline, 12 weeks]
Monocyte LDL receptor protein by Western blot, normalized to β-actin after chronic supplementation. Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose.
- Plasma Area Under the Curve of Chokeberry Polyphenols and Their Metabolites. [0, 0.5, 1, 2, 4, 6, 9, 12, and 24 hours following dose]
Plasma area under the curve of chokeberry polyphenols and their metabolites. Measurement (time 0) began at study baseline. Not determined in chronic arms (Color-matched Rice Powder Pill or Chokeberry Extract Capsule).
- Urinary Excretion of Polyphenols [0 to 24 h after consumption of extract]
Urinary excretion of polyphenols, from 0 to 24 h after consumption of extract, area under the curve (AUC) in Chokeberry Extract Capsule (acute) arm only.
- Adiponectin [Baseline, 6 weeks, 12 weeks]
Fasting plasma adiponectin after chronic consumption. Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose.
- Interleukin-1 Beta [Baseline, 6 weeks, 12 weeks]
Fasting plasma interleukin-1 beta after chronic consumption. Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose.
- Interleukin-6 [Baseline, 6 weeks, 12 weeks]
Fasting plasma interleukin-6 after chronic supplementation. Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose.
- Monocyte Chemoattractant Protein-1 [Baseline, 6 weeks, 12 weeks]
Fasting plasma monocyte chemoattractant protein-1 after chronic supplementation. Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose.
- Tumor Necrosis Factor-alpha [Baseline, 6 weeks, 12 weeks]
Fasting plasma Tumor necrosis factor-alpha after chronic supplementation. Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose.
- C-reactive Protein [Baseline, 6 weeks, 12 weeks]
Fasting plasma C-reactive protein after chronic supplementation. Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose.
- Intercellular Adhesion Molecule 1 [Baseline, 6 weeks, 12 weeks]
Fasting plasma intercellular adhesion molecule 1 after chronic supplementation. Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose.
- Soluble Vascular Cell Adhesion Molecule 1 [Baseline, 6 weeks, 12 weeks]
Fasting plasma soluble vascular cell adhesion molecule 1 after chronic consumption. Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose.
- P-selectin [Baseline, 6 weeks, 12 weeks]
Fasting plasma P-selectin after chronic supplementation. Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose.
- Total Antioxidant Capacity [Baseline, 6 weeks, 12 weeks]
Fasting plasma total antioxidant capacity after chronic supplementation. Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose.
- Catalase Activity [Baseline, 6 weeks, 12 weeks]
Catalase activity after chronic supplementation. Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose.
- Glutathione Peroxidase Activity [Baseline, 6 weeks, 12 weeks]
Fasting plasma glutathione peroxidase activity after chronic supplementation. Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose.
- Superoxide Dismutase Activity [Baseline, 6 weeks, 12 weeks]
Fasting plasma superoxide dismutase after chronic supplementation. Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose.
- Urinary Polyphenol Excretion [12 weeks]
Overnight urinary polyphenol excretion after chronic supplementation. Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose.
- Energy-adjusted Nutrient Intake: Carbohydrate, Protein, Fat, Fiber [Baseline, 12 weeks]
Energy-adjusted intake based on 3-day dietary recalls, determined by the average of baseline and 12 weeks. Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose.
- Energy Intake [Baseline, 12 weeks]
Energy intake reported from 3-day dietary recalls at baseline and 12 weeks, determined by the average of baseline and 12 weeks. Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose.
- Energy-adjusted Micronutrient Intake [Baseline, 12 weeks]
Energy-adjusted micronutrient intake from 3-day dietary recalls at baseline and 12 weeks. Values reported as the average of baseline and 12 weeks. Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose.
- Polyphenol Intake [Baseline, 12 weeks]
Energy-adjusted polyphenol intake assessed by 3-day dietary recalls at baseline and 12 weeks, values determined by average of baseline and 12 weeks. Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose.
- Intake of Dietary Antioxidant Capacity [Baseline, 12 weeks]
Energy-adjusted intake of dietary antioxidant capacity determined by 3-day dietary recalls at baseline and 12 weeks. Values reported as average of baseline and 12 weeks. Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose.
- Energy-adjusted Vitamin A Intake [Baseline, 12 weeks]
Energy-adjusted vitamin A intake from 3-day dietary recalls at baseline and 12 weeks. Values reported as the average of baseline and 12 weeks. Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Former smoker (previously smoked ≥3 cigarettes/day for at least 1 year, cessation for at least 6 months
-
Healthy male or female between 18-65 y
-
Serum clinical ranges no more than mildly elevated (serum cholesterol <240 mg/dL) and serum triglyceride (<150 mg/dL)
-
Resting blood pressure <140/90 mm Hg
-
Stable body weight (±5 lb) for last 2 months
-
BMI ranges within normal and overweight (18.5-39 kg/m2)
-
Willing to maintain normal exercise level (<7 h/wk)
-
Willing to avoid exercise 24 h prior to blood sampling
-
Willing to ingest a dietary chokeberry supplement or placebo (500 mg/d) daily for 12 wks.
Exclusion Criteria:
-
Previous diagnoses of CVD, diabetes, or arthritis (except for osteo-arthritis)
-
Currently being treated for cancer (i.e., chemotherapy, radiation therapy)
-
Women with prescribed estrogen replacement therapy
-
Practicing slimming diet
-
Practicing vegetarian diet
-
Currently taking vitamin or mineral supplements or plant pills
-
Alcohol consumption exceeding the definition of moderate drinking (2 drinks/day or a total of 12/week for men or 1 drink/day or a total of 7/week for women)
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Roy E. Jones Building | Storrs | Connecticut | United States | 06269 |
Sponsors and Collaborators
- University of Connecticut
Investigators
- Principal Investigator: Bradley W Bolling, PhD, University of Connecticut, University of Wisconsin-Madison
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- H11-311
- 120068
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | Color-matched Rice Powder Pill | Chokeberry Extract Capsule | Chaokeberry Extract Capsule (Acute) |
|---|---|---|---|
| Arm/Group Description | Color-matched rice powder pill Placebo capsule: Color-matched rice powder pill, 2 x 250 mg/day for 12 weeks | Chokeberry extract capsule Chokeberry Extract: Consumption of 2 x 250 mg chokeberry extract capsules daily for 12 weeks. Chokeberry extract capsule, acute: Chokeberry extract capsule, 2 x 250 mg, one-time dose. | Chokeberry extract capsule, acute: Chokeberry extract capsule, 2 x 250 mg, one-time dose. |
| Period Title: Overall Study | |||
| STARTED | 28 | 28 | 6 |
| COMPLETED | 24 | 25 | 6 |
| NOT COMPLETED | 4 | 3 | 0 |
Baseline Characteristics
| Arm/Group Title | Color-matched Rice Powder Pill | Chokeberry Extract Capsule | Chokeberry Extract Capsule (Acute) | Total |
|---|---|---|---|---|
| Arm/Group Description | Color-matched rice powder pill Placebo capsule: Color-matched rice powder pill, 2 x 250 mg/day for 12 weeks | Chokeberry extract capsule Chokeberry Extract: Consumption of 2 x 250 mg chokeberry extract capsules daily for 12 weeks. | Chokeberry extract capsule, acute: Chokeberry extract capsule, 2 x 250 mg, one-time dose. | Total of all reporting groups |
| Overall Participants | 24 | 25 | 6 | 55 |
| Age (years) [Mean (Standard Deviation) ] | ||||
| Mean (Standard Deviation) [years] |
37.4
(14.8)
|
32.6
(12.7)
|
31.3
(12.8)
|
34.9
(13.9)
|
| Sex: Female, Male (Count of Participants) | ||||
| Female |
13
54.2%
|
12
48%
|
3
50%
|
28
50.9%
|
| Male |
11
45.8%
|
13
52%
|
3
50%
|
27
49.1%
|
| Height (m) [Mean (Standard Deviation) ] | ||||
| Mean (Standard Deviation) [m] |
1.73
(0.92)
|
1.71
(0.83)
|
1.74
(0.97)
|
1.72
(0.87)
|
| Average years of smoking (years) [Mean (Standard Deviation) ] | ||||
| Mean (Standard Deviation) [years] |
14.9
(11.9)
|
8.96
(6.68)
|
4.8
(3.0)
|
11.9
(10.0)
|
| Degree of past smoking (Count of Participants) | ||||
| 3-5 cigarettes/day |
2
8.3%
|
4
16%
|
1
16.7%
|
7
12.7%
|
| 6-10 cigarettes/day |
4
16.7%
|
7
28%
|
1
16.7%
|
12
21.8%
|
| 11-15 cigarettes/day |
4
16.7%
|
4
16%
|
2
33.3%
|
10
18.2%
|
| 16-20 cigarettes/day |
11
45.8%
|
6
24%
|
0
0%
|
17
30.9%
|
| >20 cigarettes/day |
3
12.5%
|
4
16%
|
1
16.7%
|
8
14.5%
|
| Weight (kg) [Mean (Standard Deviation) ] | ||||
| Mean (Standard Deviation) [kg] |
81.5
(17.2)
|
77.2
(21.1)
|
72.8
(9.5)
|
79.3
(19.2)
|
| BMI (kg/m^2) [Mean (Standard Deviation) ] | ||||
| Mean (Standard Deviation) [kg/m^2] |
27.2
(4.7)
|
25.7
(5.0)
|
24.1
(2.3)
|
26.5
(4.9)
|
| Waist circumference (cm) [Mean (Standard Deviation) ] | ||||
| Mean (Standard Deviation) [cm] |
86.0
(17.1)
|
90.9
(35.1)
|
79.4
(8.4)
|
88.5
(27.6)
|
| Systolic blood pressure (mmHg) [Mean (Standard Deviation) ] | ||||
| Mean (Standard Deviation) [mmHg] |
121
(14)
|
117
(16)
|
111.3
(7.7)
|
119
(15)
|
| Diastolic blood pressure (mmHg) [Mean (Standard Deviation) ] | ||||
| Mean (Standard Deviation) [mmHg] |
76.0
(10.4)
|
75.3
(12.0)
|
73.3
(4.7)
|
75.6
(11.0)
|
| Total cholesterol (mg/dL) [Mean (Standard Deviation) ] | ||||
| Mean (Standard Deviation) [mg/dL] |
203
(36)
|
220
(63)
|
160
(30)
|
213
(51)
|
| HDL-cholesterol (mg/dL) [Mean (Standard Deviation) ] | ||||
| Mean (Standard Deviation) [mg/dL] |
28.7
(6.1)
|
26.8
(7.6)
|
54.8
(15.7)
|
27.6
(6.9)
|
| LDL-cholesterol (mg/dL) [Mean (Standard Deviation) ] | ||||
| Mean (Standard Deviation) [mg/dL] |
158
(30)
|
175
(54)
|
99.2
(19.2)
|
168
(44)
|
| Triglycerides (mg/dL) [Mean (Standard Deviation) ] | ||||
| Mean (Standard Deviation) [mg/dL] |
82.1
(37.3)
|
89.6
(45.4)
|
69.2
(27.1)
|
86.3
(41.0)
|
| Total cholesterol/HDL cholesterol (dimensionless ratio) [Mean (Standard Deviation) ] | ||||
| Mean (Standard Deviation) [dimensionless ratio] |
7.3
(1.5)
|
8.5
(2.7)
|
3.2
(0.7)
|
8.0
(2.3)
|
Outcome Measures
| Title | LDL Cholesterol |
|---|---|
| Description | Change in LDL cholesterol from baseline after chronic supplementation. Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose. |
| Time Frame | Baseline, 6 weeks, 12 weeks of intervention |
Outcome Measure Data
| Analysis Population Description |
|---|
| Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose. |
| Arm/Group Title | Color-matched Rice Powder Pill | Chokeberry Extract Capsule |
|---|---|---|
| Arm/Group Description | Color-matched rice powder pill Placebo capsule: Color-matched rice powder pill, 2 x 250 mg/day for 12 weeks | Chokeberry Extract: Consumption of 2 x 250 mg chokeberry extract capsules daily for 12 weeks. |
| Measure Participants | 24 | 25 |
| 6 weeks |
0.9
(4.2)
|
-12.6
(5.3)
|
| 12 weeks |
-0.4
(5.9)
|
-18.5
(7.8)
|
| Title | Total Cholesterol |
|---|---|
| Description | Change in fasting total cholesterol from baseline after chronic supplementation. Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose. |
| Time Frame | 6 and 12 weeks after supplementation |
Outcome Measure Data
| Analysis Population Description |
|---|
| Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose. |
| Arm/Group Title | Color-matched Rice Powder Pill | Chokeberry Extract Capsule |
|---|---|---|
| Arm/Group Description | Color-matched rice powder pill Placebo capsule: Color-matched rice powder pill, 2 x 250 mg/day for 12 weeks | Chokeberry Extract: Consumption of 2 x 250 mg chokeberry extract capsules daily for 12 weeks. |
| Measure Participants | 24 | 25 |
| Baseline |
203
(7)
|
220
(13)
|
| 6 weeks (change from baseline) |
-0.1
(4.6)
|
1.4
(2.5)
|
| 12 weeks (change from baseline) |
-1.3
(6.4)
|
-17.9
(7.6)
|
| Title | HDL-cholesterol |
|---|---|
| Description | Change in fasting plasma cholesterol from baseline after chronic supplemenation. Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose. |
| Time Frame | 6 and 12 weeks after supplementation |
Outcome Measure Data
| Analysis Population Description |
|---|
| Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose. |
| Arm/Group Title | Color-matched Rice Powder Pill | Chokeberry Extract Capsule |
|---|---|---|
| Arm/Group Description | Color-matched rice powder pill Placebo capsule: Color-matched rice powder pill, 2 x 250 mg/day for 12 weeks | Chokeberry Extract: Consumption of 2 x 250 mg chokeberry extract capsules daily for 12 weeks. |
| Measure Participants | 24 | 25 |
| Baseline |
28.8
(1.3)
|
26.8
(1.5)
|
| 6 weeks (change from baseline) |
-0.9
(1.0)
|
0.2
(0.8)
|
| 12 weeks (change from baseline) |
-0.7
(1.4)
|
0.2
(0.8)
|
| Title | Triglycerides |
|---|---|
| Description | Change in fasting plasma triglycerides from baseline after chronic supplementation. Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose. |
| Time Frame | 6 and 12 weeks after supplementation |
Outcome Measure Data
| Analysis Population Description |
|---|
| Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose. |
| Arm/Group Title | Color-matched Rice Powder Pill | Chokeberry Extract Capsule |
|---|---|---|
| Arm/Group Description | Color-matched rice powder pill Placebo capsule: Color-matched rice powder pill, 2 x 250 mg/day for 12 weeks | Chokeberry Extract: Consumption of 2 x 250 mg chokeberry extract capsules daily for 12 weeks. |
| Measure Participants | 24 | 25 |
| Baseline |
82.1
(7.6)
|
89.6
(9.0)
|
| 6 weeks (change from baseline) |
-0.6
(2.7)
|
1.0
(5.9)
|
| 12 weeks (change from baseline) |
-1.0
(5.9)
|
2.0
(8.5)
|
| Title | Resting Systolic Blood Pressure |
|---|---|
| Description | Change in resting systolic blood pressure after chronic supplementation. Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose. |
| Time Frame | Baseline, 6 weeks, and 12 weeks following intervention |
Outcome Measure Data
| Analysis Population Description |
|---|
| Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose. |
| Arm/Group Title | Color-matched Rice Powder Pill | Chokeberry Extract Capsule |
|---|---|---|
| Arm/Group Description | Color-matched rice powder pill Placebo capsule: Color-matched rice powder pill, 2 x 250 mg/day for 12 weeks | Chokeberry Extract: Consumption of 2 x 250 mg chokeberry extract capsules daily for 12 weeks. |
| Measure Participants | 24 | 25 |
| Baseline |
121
(3)
|
117
(3)
|
| 6 weeks (change from baseline) |
-0.8
(1.5)
|
2.8
(1.7)
|
| 12 weeks (change from baseline) |
0.2
(2.9)
|
1.2
(2.4)
|
| Title | Resting Diastolic Blood Pressure |
|---|---|
| Description | Change in resting diastolic blood pressure after chronic supplementation. Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose. |
| Time Frame | Baseline, 6 weeks, and 12 weeks following intervention |
Outcome Measure Data
| Analysis Population Description |
|---|
| Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose. |
| Arm/Group Title | Color-matched Rice Powder Pill | Chokeberry Extract Capsule |
|---|---|---|
| Arm/Group Description | Color-matched rice powder pill Placebo capsule: Color-matched rice powder pill, 2 x 250 mg/day for 12 weeks | Chokeberry Extract: Consumption of 2 x 250 mg chokeberry extract capsules daily for 12 weeks. |
| Measure Participants | 24 | 25 |
| Baseline |
76.0
(2.1)
|
75.3
(2.4)
|
| 6 weeks (change from baseline) |
-1.2
(2.4)
|
5.0
(1.3)
|
| 12 weeks (change from baseline) |
-1.1
(1.7)
|
2.0
(1.5)
|
| Title | Urinary F2-isoprostanes |
|---|---|
| Description | Change in resting urinary F2-isoprostanes after chronic supplementation. Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose. |
| Time Frame | Baseline and 12 weeks following intervention |
Outcome Measure Data
| Analysis Population Description |
|---|
| Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose. |
| Arm/Group Title | Color-matched Rice Powder Pill | Chokeberry Extract Capsule |
|---|---|---|
| Arm/Group Description | Color-matched rice powder pill Placebo capsule: Color-matched rice powder pill, 2 x 250 mg/day for 12 weeks | Chokeberry Extract: Consumption of 2 x 250 mg chokeberry extract capsules daily for 12 weeks. |
| Measure Participants | 24 | 25 |
| Baseline |
71.0
(8.1)
|
58.6
(7.0)
|
| 12 weeks |
81.6
(7.8)
|
68.4
(9.0)
|
| Title | 3-hydroxy-3-methyl-glutaryl Coenzyme A Reductase (HMGR) |
|---|---|
| Description | Monocyte messenger ribonucleic acid (mRNA) expression normalized to glyceraldehyde-3-phosphate dehydrogenase (GAPDH) after chronic supplementation. Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose. |
| Time Frame | Baseline, 12 wk |
Outcome Measure Data
| Analysis Population Description |
|---|
| Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose. |
| Arm/Group Title | Color-matched Rice Powder Pill | Chokeberry Extract Capsule |
|---|---|---|
| Arm/Group Description | Color-matched rice powder pill Placebo capsule: Color-matched rice powder pill, 2 x 250 mg/day for 12 weeks | Chokeberry Extract: Consumption of 2 x 250 mg chokeberry extract capsules daily for 12 weeks. |
| Measure Participants | 24 | 25 |
| Baseline |
0.90
(0.06)
|
0.91
(0.06)
|
| 12 weeks |
1.16
(0.28)
|
0.79
(0.12)
|
| Title | LDL Receptor (LDLR) |
|---|---|
| Description | Monocyte LDL receptor mRNA normalized to glyceraldehyde-3-phosphate dehydrogenase after chronic supplementation. Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose. |
| Time Frame | Change from baseline at 12 weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose. |
| Arm/Group Title | Color-matched Rice Powder Pill | Chokeberry Extract Capsule |
|---|---|---|
| Arm/Group Description | Color-matched rice powder pill Placebo capsule: Color-matched rice powder pill, 2 x 250 mg/day for 12 weeks | Chokeberry Extract: Consumption of 2 x 250 mg chokeberry extract capsules daily for 12 weeks. |
| Measure Participants | 24 | 25 |
| Baseline |
0.90
(0.07)
|
0.84
(0.07)
|
| 12 weeks |
0.93
(0.22)
|
0.88
(0.26)
|
| Title | LDL Receptor (LDLR) Protein |
|---|---|
| Description | Monocyte LDL receptor protein by Western blot, normalized to β-actin after chronic supplementation. Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose. |
| Time Frame | Baseline, 12 weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose. |
| Arm/Group Title | Color-matched Rice Powder Pill | Chokeberry Extract Capsule |
|---|---|---|
| Arm/Group Description | Color-matched rice powder pill Placebo capsule: Color-matched rice powder pill, 2 x 250 mg/day for 12 weeks | Chokeberry Extract: Consumption of 2 x 250 mg chokeberry extract capsules daily for 12 weeks. |
| Measure Participants | 24 | 25 |
| Baseline |
1.71
(0.33)
|
1.45
(0.06)
|
| 12 weeks |
2.47
(0.80)
|
1.45
(0.64)
|
| Title | Plasma Area Under the Curve of Chokeberry Polyphenols and Their Metabolites. |
|---|---|
| Description | Plasma area under the curve of chokeberry polyphenols and their metabolites. Measurement (time 0) began at study baseline. Not determined in chronic arms (Color-matched Rice Powder Pill or Chokeberry Extract Capsule). |
| Time Frame | 0, 0.5, 1, 2, 4, 6, 9, 12, and 24 hours following dose |
Outcome Measure Data
| Analysis Population Description |
|---|
| Not determined in chronic arms (Color-matched Rice Powder Pill or Chokeberry Extract Capsule) as this analysis required additional collection time-points that were not utilized in the other arms. |
| Arm/Group Title | Chokeberry Extract Capsule (Acute) |
|---|---|
| Arm/Group Description | Chokeberry extract capsule, acute: Chokeberry extract capsule, 2 x 250 mg, one-time dose. |
| Measure Participants | 6 |
| Protocatechuic acid |
0.054
(0.013)
|
| Hippuric acid |
22.350
(4.441)
|
| 3-(4-Hydroxyphenyl)propionic acid |
2.725
(2.391)
|
| Cyanidin-3-O-glucoside |
0.462
(0.170)
|
| Peonidin-3-O-galactoside |
0.627
(0.198)
|
| Title | Urinary Excretion of Polyphenols |
|---|---|
| Description | Urinary excretion of polyphenols, from 0 to 24 h after consumption of extract, area under the curve (AUC) in Chokeberry Extract Capsule (acute) arm only. |
| Time Frame | 0 to 24 h after consumption of extract |
Outcome Measure Data
| Analysis Population Description |
|---|
| Not determined in chronic arms (Color-matched Rice Powder Pill or Chokeberry Extract Capsule) as this analysis required additional collection time-points that were not utilized in the other arms. |
| Arm/Group Title | Chokeberry Extract Capsule (Acute) |
|---|---|
| Arm/Group Description | Chokeberry extract capsule, acute: Chokeberry extract capsule, 2 x 250 mg, one-time dose. |
| Measure Participants | 6 |
| Protocatechuic acid |
3.682
(0.587)
|
| 3,4-dihyrdoxyphenylacetic acid |
11.426
(0.881)
|
| Hippuric acid |
2429.852
(360.197)
|
| 3-(4-hydroxyphenyl)propionic acid |
2.299
(0.715)
|
| Cyanidin-3-O-galactoside |
0.016
(0.005)
|
| Cyanidin-3-O-glucoside |
0.118
(0.070)
|
| Cyanidin-3-O-arabinoside |
0.088
(0.031)
|
| Peonidin-3-O-galactoside |
0.053
(0.012)
|
| Title | Adiponectin |
|---|---|
| Description | Fasting plasma adiponectin after chronic consumption. Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose. |
| Time Frame | Baseline, 6 weeks, 12 weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose. |
| Arm/Group Title | Color-matched Rice Powder Pill | Chokeberry Extract Capsule |
|---|---|---|
| Arm/Group Description | Color-matched rice powder pill Placebo capsule: Color-matched rice powder pill, 2 x 250 mg/day for 12 weeks | Chokeberry Extract: Consumption of 2 x 250 mg chokeberry extract capsules daily for 12 weeks. |
| Measure Participants | 24 | 25 |
| Baseline |
13.2
(1.9)
|
12.8
(1.5)
|
| 6 weeks |
14.2
(2.0)
|
13.8
(1.7)
|
| 12 weeks |
12.5
(1.6)
|
13.2
(1.5)
|
| Title | Interleukin-1 Beta |
|---|---|
| Description | Fasting plasma interleukin-1 beta after chronic consumption. Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose. |
| Time Frame | Baseline, 6 weeks, 12 weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose. |
| Arm/Group Title | Color-matched Rice Powder Pill | Chokeberry Extract Capsule |
|---|---|---|
| Arm/Group Description | Color-matched rice powder pill Placebo capsule: Color-matched rice powder pill, 2 x 250 mg/day for 12 weeks | Chokeberry Extract: Consumption of 2 x 250 mg chokeberry extract capsules daily for 12 weeks. |
| Measure Participants | 24 | 25 |
| Baseline |
9.3
(2.4)
|
16.2
(8.6)
|
| 6 weeks |
9.5
(2.7)
|
17.0
(9.7)
|
| 12 weeks |
10.1
(3.0)
|
14.7
(7.4)
|
| Title | Interleukin-6 |
|---|---|
| Description | Fasting plasma interleukin-6 after chronic supplementation. Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose. |
| Time Frame | Baseline, 6 weeks, 12 weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose. |
| Arm/Group Title | Color-matched Rice Powder Pill | Chokeberry Extract Capsule |
|---|---|---|
| Arm/Group Description | Color-matched rice powder pill Placebo capsule: Color-matched rice powder pill, 2 x 250 mg/day for 12 weeks | Chokeberry Extract: Consumption of 2 x 250 mg chokeberry extract capsules daily for 12 weeks. |
| Measure Participants | 24 | 25 |
| Baseline |
1.94
(0.34)
|
4.68
(1.34)
|
| 6 weeks |
1.87
(0.38)
|
5.16
(1.54)
|
| 12 weeks |
1.76
(0.29)
|
5.34
(1.52)
|
| Title | Monocyte Chemoattractant Protein-1 |
|---|---|
| Description | Fasting plasma monocyte chemoattractant protein-1 after chronic supplementation. Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose. |
| Time Frame | Baseline, 6 weeks, 12 weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose. |
| Arm/Group Title | Color-matched Rice Powder Pill | Chokeberry Extract Capsule |
|---|---|---|
| Arm/Group Description | Color-matched rice powder pill Placebo capsule: Color-matched rice powder pill, 2 x 250 mg/day for 12 weeks | Chokeberry Extract: Consumption of 2 x 250 mg chokeberry extract capsules daily for 12 weeks. |
| Measure Participants | 24 | 25 |
| Baseline |
97
(6)
|
133
(31)
|
| 6 weeks |
96
(5)
|
167
(43)
|
| 12 weeks |
91
(5)
|
141
(27)
|
| Title | Tumor Necrosis Factor-alpha |
|---|---|
| Description | Fasting plasma Tumor necrosis factor-alpha after chronic supplementation. Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose. |
| Time Frame | Baseline, 6 weeks, 12 weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose. |
| Arm/Group Title | Color-matched Rice Powder Pill | Chokeberry Extract Capsule |
|---|---|---|
| Arm/Group Description | Color-matched rice powder pill Placebo capsule: Color-matched rice powder pill, 2 x 250 mg/day for 12 weeks | Chokeberry Extract: Consumption of 2 x 250 mg chokeberry extract capsules daily for 12 weeks. |
| Measure Participants | 24 | 25 |
| Baseline |
4.36
(1.83)
|
5.90
(1.63)
|
| 6 weeks |
4.70
(1.89)
|
6.44
(1.83)
|
| 12 weeks |
4.86
(1.85)
|
6.10
(1.72)
|
| Title | C-reactive Protein |
|---|---|
| Description | Fasting plasma C-reactive protein after chronic supplementation. Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose. |
| Time Frame | Baseline, 6 weeks, 12 weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose. |
| Arm/Group Title | Color-matched Rice Powder Pill | Chokeberry Extract Capsule |
|---|---|---|
| Arm/Group Description | Color-matched rice powder pill Placebo capsule: Color-matched rice powder pill, 2 x 250 mg/day for 12 weeks | Chokeberry Extract: Consumption of 2 x 250 mg chokeberry extract capsules daily for 12 weeks. |
| Measure Participants | 24 | 25 |
| Baseline |
2.54
(0.60)
|
2.01
(0.34)
|
| 6 weeks |
2.18
(0.42)
|
2.32
(0.39)
|
| 12 weeks |
2.24
(0.38)
|
2.29
(0.49)
|
| Title | Intercellular Adhesion Molecule 1 |
|---|---|
| Description | Fasting plasma intercellular adhesion molecule 1 after chronic supplementation. Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose. |
| Time Frame | Baseline, 6 weeks, 12 weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose. |
| Arm/Group Title | Color-matched Rice Powder Pill | Chokeberry Extract Capsule |
|---|---|---|
| Arm/Group Description | Color-matched rice powder pill Placebo capsule: Color-matched rice powder pill, 2 x 250 mg/day for 12 weeks | Chokeberry Extract: Consumption of 2 x 250 mg chokeberry extract capsules daily for 12 weeks. |
| Measure Participants | 24 | 25 |
| Baseline |
97.1
(7.2)
|
96.6
(5.4)
|
| 6 weeks |
97.6
(7.2)
|
99.4
(5.7)
|
| 12 weeks |
100
(8)
|
97.5
(5.8)
|
| Title | Soluble Vascular Cell Adhesion Molecule 1 |
|---|---|
| Description | Fasting plasma soluble vascular cell adhesion molecule 1 after chronic consumption. Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose. |
| Time Frame | Baseline, 6 weeks, 12 weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose. |
| Arm/Group Title | Color-matched Rice Powder Pill | Chokeberry Extract Capsule |
|---|---|---|
| Arm/Group Description | Color-matched rice powder pill Placebo capsule: Color-matched rice powder pill, 2 x 250 mg/day for 12 weeks | Chokeberry Extract: Consumption of 2 x 250 mg chokeberry extract capsules daily for 12 weeks. |
| Measure Participants | 24 | 25 |
| Baseline |
585
(23)
|
601
(31)
|
| 6 weeks |
604
(23)
|
622
(31)
|
| 12 weeks |
604
(26)
|
599
(27)
|
| Title | P-selectin |
|---|---|
| Description | Fasting plasma P-selectin after chronic supplementation. Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose. |
| Time Frame | Baseline, 6 weeks, 12 weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose. |
| Arm/Group Title | Color-matched Rice Powder Pill | Chokeberry Extract Capsule |
|---|---|---|
| Arm/Group Description | Color-matched rice powder pill Placebo capsule: Color-matched rice powder pill, 2 x 250 mg/day for 12 weeks | Chokeberry Extract: Consumption of 2 x 250 mg chokeberry extract capsules daily for 12 weeks. |
| Measure Participants | 24 | 25 |
| Baseline |
130
(13)
|
124
(12)
|
| 6 weeks |
111
(11)
|
127
(12)
|
| 12 weeks |
131
(11)
|
145
(17)
|
| Title | Total Antioxidant Capacity |
|---|---|
| Description | Fasting plasma total antioxidant capacity after chronic supplementation. Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose. |
| Time Frame | Baseline, 6 weeks, 12 weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose. |
| Arm/Group Title | Color-matched Rice Powder Pill | Chokeberry Extract Capsule |
|---|---|---|
| Arm/Group Description | Color-matched rice powder pill Placebo capsule: Color-matched rice powder pill, 2 x 250 mg/day for 12 weeks | Chokeberry Extract: Consumption of 2 x 250 mg chokeberry extract capsules daily for 12 weeks. |
| Measure Participants | 24 | 25 |
| Baseline |
210
(4)
|
208
(3)
|
| 6 weeks |
214
(3)
|
211
(3)
|
| 12 weeks |
209
(4)
|
207
(4)
|
| Title | Catalase Activity |
|---|---|
| Description | Catalase activity after chronic supplementation. Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose. |
| Time Frame | Baseline, 6 weeks, 12 weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose. |
| Arm/Group Title | Color-matched Rice Powder Pill | Chokeberry Extract Capsule |
|---|---|---|
| Arm/Group Description | Color-matched rice powder pill Placebo capsule: Color-matched rice powder pill, 2 x 250 mg/day for 12 weeks | Chokeberry Extract: Consumption of 2 x 250 mg chokeberry extract capsules daily for 12 weeks. |
| Measure Participants | 24 | 25 |
| Baseline |
41.7
(1.4)
|
41.1
(2.1)
|
| 6 weeks |
35.5
(1.2)
|
38.7
(1.5)
|
| 12 weeks |
41.7
(2.3)
|
41.2
(1.8)
|
| Title | Glutathione Peroxidase Activity |
|---|---|
| Description | Fasting plasma glutathione peroxidase activity after chronic supplementation. Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose. |
| Time Frame | Baseline, 6 weeks, 12 weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose. |
| Arm/Group Title | Color-matched Rice Powder Pill | Chokeberry Extract Capsule |
|---|---|---|
| Arm/Group Description | Color-matched rice powder pill Placebo capsule: Color-matched rice powder pill, 2 x 250 mg/day for 12 weeks | Chokeberry Extract: Consumption of 2 x 250 mg chokeberry extract capsules daily for 12 weeks. |
| Measure Participants | 24 | 25 |
| Baseline |
2550
(140)
|
2550
(140)
|
| 6 weeks |
2560
(130)
|
2500
(160)
|
| 12 weeks |
2470
(110)
|
2650
(190)
|
| Title | Superoxide Dismutase Activity |
|---|---|
| Description | Fasting plasma superoxide dismutase after chronic supplementation. Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose. |
| Time Frame | Baseline, 6 weeks, 12 weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose. |
| Arm/Group Title | Color-matched Rice Powder Pill | Chokeberry Extract Capsule |
|---|---|---|
| Arm/Group Description | Color-matched rice powder pill Placebo capsule: Color-matched rice powder pill, 2 x 250 mg/day for 12 weeks | Chokeberry Extract: Consumption of 2 x 250 mg chokeberry extract capsules daily for 12 weeks. |
| Measure Participants | 24 | 25 |
| Baseline |
1190
(50)
|
1180
(40)
|
| 6 weeks |
1190
(50)
|
1160
(40)
|
| 12 weeks |
1160
(60)
|
1160
(40)
|
| Title | Urinary Polyphenol Excretion |
|---|---|
| Description | Overnight urinary polyphenol excretion after chronic supplementation. Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose. |
| Time Frame | 12 weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose. |
| Arm/Group Title | Color-matched Rice Powder Pill | Chokeberry Extract Capsule |
|---|---|---|
| Arm/Group Description | Color-matched rice powder pill Placebo capsule: Color-matched rice powder pill, 2 x 250 mg/day for 12 weeks | Chokeberry Extract: Consumption of 2 x 250 mg chokeberry extract capsules daily for 12 weeks. |
| Measure Participants | 24 | 25 |
| Protocatechuic acid |
1.38
|
1.20
|
| 3,4-dihydroxyphenylacetic acid |
5.04
|
4.56
|
| Hippuric acid |
133
|
138
|
| Ferulic acid |
0.68
|
0.71
|
| 3-(4-hydroxyphenyl)propionic acid |
3.91
|
3.36
|
| Cyanidin-3-O-glucoside |
0
|
0.00907
|
| Cyanidin-3-O-galactoside |
0
|
0.00466
|
| Cyanidin-3-O-arabinoside |
0
|
0
|
| Peonidin-3-O-galactoside |
0
|
0.008
|
| Sum anthocyanins |
0.014
|
0.134
|
| Title | Energy-adjusted Nutrient Intake: Carbohydrate, Protein, Fat, Fiber |
|---|---|
| Description | Energy-adjusted intake based on 3-day dietary recalls, determined by the average of baseline and 12 weeks. Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose. |
| Time Frame | Baseline, 12 weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| Survey data were not available for two participants in the "Color-matched rice powder pill" group. Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose. |
| Arm/Group Title | Color-matched Rice Powder Pill | Chokeberry Extract Capsule |
|---|---|---|
| Arm/Group Description | Color-matched rice powder pill Placebo capsule: Color-matched rice powder pill, 2 x 250 mg/day for 12 weeks | Chokeberry Extract: Consumption of 2 x 250 mg chokeberry extract capsules daily for 12 weeks. |
| Measure Participants | 22 | 25 |
| Carbohydrate |
238
(9)
|
241
(9)
|
| Protein |
89.2
(3.3)
|
90.3
(3.1)
|
| Fat |
27.8
(4.0)
|
77.6
(29.5)
|
| Fiber |
23.5
(1.6)
|
21.0
(1.5)
|
| Title | Energy Intake |
|---|---|
| Description | Energy intake reported from 3-day dietary recalls at baseline and 12 weeks, determined by the average of baseline and 12 weeks. Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose. |
| Time Frame | Baseline, 12 weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| Survey data were not available for two participants in the "Color-matched rice powder pill" group. Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose. |
| Arm/Group Title | Color-matched Rice Powder Pill | Chokeberry Extract Capsule |
|---|---|---|
| Arm/Group Description | Color-matched rice powder pill Placebo capsule: Color-matched rice powder pill, 2 x 250 mg/day for 12 weeks | Chokeberry Extract: Consumption of 2 x 250 mg chokeberry extract capsules daily for 12 weeks. |
| Measure Participants | 22 | 25 |
| Mean (Standard Error) [kcal/d] |
2230
(735)
|
1950
(530)
|
| Title | Energy-adjusted Micronutrient Intake |
|---|---|
| Description | Energy-adjusted micronutrient intake from 3-day dietary recalls at baseline and 12 weeks. Values reported as the average of baseline and 12 weeks. Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose. |
| Time Frame | Baseline, 12 weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| Survey data were not available for two participants in the "Color-matched rice powder pill" group. Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose. |
| Arm/Group Title | Color-matched Rice Powder Pill | Chokeberry Extract Capsule |
|---|---|---|
| Arm/Group Description | Color-matched rice powder pill Placebo capsule: Color-matched rice powder pill, 2 x 250 mg/day for 12 weeks | Chokeberry Extract: Consumption of 2 x 250 mg chokeberry extract capsules daily for 12 weeks. |
| Measure Participants | 22 | 25 |
| Sodium |
3490
(160)
|
3480
(150)
|
| Calcium |
947
(58)
|
1070
(50)
|
| Iron |
16.9
(1.3)
|
16.9
(1.2)
|
| Vitamin D |
5.0
(0.9)
|
7.1
(0.8)
|
| Vitamin C |
80.9
(12.9)
|
90.9
(12.1)
|
| Vitamin E |
10.6
(1.1)
|
10.8
(1.1)
|
| Title | Polyphenol Intake |
|---|---|
| Description | Energy-adjusted polyphenol intake assessed by 3-day dietary recalls at baseline and 12 weeks, values determined by average of baseline and 12 weeks. Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose. |
| Time Frame | Baseline, 12 weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| Survey data were not available for two participants in the "Color-matched rice powder pill" group. Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose. |
| Arm/Group Title | Color-matched Rice Powder Pill | Chokeberry Extract Capsule |
|---|---|---|
| Arm/Group Description | Color-matched rice powder pill Placebo capsule: Color-matched rice powder pill, 2 x 250 mg/day for 12 weeks | Chokeberry Extract: Consumption of 2 x 250 mg chokeberry extract capsules daily for 12 weeks. |
| Measure Participants | 22 | 25 |
| Isoflavones |
3.9
(2.7)
|
8.5
(2.6)
|
| Flavanols |
73.9
(20.0)
|
81.7
(18.7)
|
| Flavones |
54.1
(29.1)
|
50.3
(27.2)
|
| Flavanones |
28.8
(11.4)
|
22.4
(10.7)
|
| Flavan-3-ols |
20.6
(7.4)
|
26.0
(6.9)
|
| Anthocyanins |
18.2
(5.2)
|
26.6
(4.8)
|
| Proanthocyanidins |
222
(162)
|
418
(150)
|
| Title | Intake of Dietary Antioxidant Capacity |
|---|---|
| Description | Energy-adjusted intake of dietary antioxidant capacity determined by 3-day dietary recalls at baseline and 12 weeks. Values reported as average of baseline and 12 weeks. Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose. |
| Time Frame | Baseline, 12 weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| Survey data were not available for two participants in the "Color-matched rice powder pill" group. Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose. |
| Arm/Group Title | Color-matched Rice Powder Pill | Chokeberry Extract Capsule |
|---|---|---|
| Arm/Group Description | Color-matched rice powder pill Placebo capsule: Color-matched rice powder pill, 2 x 250 mg/day for 12 weeks | Chokeberry Extract: Consumption of 2 x 250 mg chokeberry extract capsules daily for 12 weeks. |
| Measure Participants | 22 | 24 |
| Mean (Standard Error) [Vitamin C equivalents] |
417
(95)
|
292
(89)
|
| Title | Energy-adjusted Vitamin A Intake |
|---|---|
| Description | Energy-adjusted vitamin A intake from 3-day dietary recalls at baseline and 12 weeks. Values reported as the average of baseline and 12 weeks. Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose. |
| Time Frame | Baseline, 12 weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| Survey data were not available for two participants in the "Color-matched rice powder pill" group. Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose. |
| Arm/Group Title | Color-matched Rice Powder Pill | Chokeberry Extract Capsule |
|---|---|---|
| Arm/Group Description | Color-matched rice powder pill Placebo capsule: Color-matched rice powder pill, 2 x 250 mg/day for 12 weeks | Chokeberry Extract: Consumption of 2 x 250 mg chokeberry extract capsules daily for 12 weeks. |
| Measure Participants | 22 | 25 |
| Mean (Standard Error) [retinol equivalent mcg/day] |
3280
(740)
|
2690
(690)
|
Adverse Events
| Time Frame | During study intervention stage: 16 weeks | |||||
|---|---|---|---|---|---|---|
| Adverse Event Reporting Description | ||||||
| Arm/Group Title | Color-matched Rice Powder Pill | Chokeberry Extract Capsule | Chokeberry Extract Capsule (Acute) | |||
| Arm/Group Description | Color-matched rice powder pill Placebo capsule: Color-matched rice powder pill, 2 x 250 mg/day for 12 weeks | Chokeberry Extract: Consumption of 2 x 250 mg chokeberry extract capsules daily for 12 weeks. | Chokeberry extract capsule, acute: Chokeberry extract capsule, 2 x 250 mg, one-time dose. | |||
All Cause Mortality |
||||||
| Color-matched Rice Powder Pill | Chokeberry Extract Capsule | Chokeberry Extract Capsule (Acute) | ||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/28 (0%) | 0/28 (0%) | 0/6 (0%) | |||
Serious Adverse Events |
||||||
| Color-matched Rice Powder Pill | Chokeberry Extract Capsule | Chokeberry Extract Capsule (Acute) | ||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/28 (0%) | 0/28 (0%) | 0/6 (0%) | |||
Other (Not Including Serious) Adverse Events |
||||||
| Color-matched Rice Powder Pill | Chokeberry Extract Capsule | Chokeberry Extract Capsule (Acute) | ||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/28 (0%) | 0/28 (0%) | 0/6 (0%) | |||
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
| Name/Title | Dr. Bradley Bolling |
|---|---|
| Organization | University of Wisconsin-Madison, Department of Food Science |
| Phone | 608-890-0212 |
| bwbolling@wisc.edu |
- H11-311
- 120068