Effect of a Proprietary Dietary Supplement on Fecal Volatile Organic Compounds
Study Details
Study Description
Brief Summary
The purpose of the study is to determine the effects of both an anthocyanin-rich polyphenol blend and an anthocyanin-rich polyphenol blend combined with a prebiotic blend on fecal microbiota metabolism (assessed by gas chromatograph - mass spectrometry (GC-MS) headspace analysis) and fecal microbiota composition (assessed by next generation sequencing).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Placebo,Flavonoids,Flavonoids+Prebiotics Participants will receive three treatments, for three weeks each, with 21 day washout period between each product. |
Other: Placebo
A combination of maltodextrins and red and blue food colors.
Dietary Supplement: Flavonoids
A combination of blueberry extract, black current extract, and black rice extract.
Dietary Supplement: Flavonoids+Prebiotics
A combination of blueberry extract, black current extract, black rice extract, inulin, and fructooligosaccharide.
|
| Experimental: Placebo,Flavonoids+Prebiotics,Flavonoids Participants will receive three treatments, for three weeks each, with 21 day washout period between each product. |
Other: Placebo
A combination of maltodextrins and red and blue food colors.
Dietary Supplement: Flavonoids
A combination of blueberry extract, black current extract, and black rice extract.
Dietary Supplement: Flavonoids+Prebiotics
A combination of blueberry extract, black current extract, black rice extract, inulin, and fructooligosaccharide.
|
| Experimental: Flavonoids,Placebo,Flavonoids+Prebiotics Participants will receive three treatments, for three weeks each, with 21 day washout period between each product. |
Other: Placebo
A combination of maltodextrins and red and blue food colors.
Dietary Supplement: Flavonoids
A combination of blueberry extract, black current extract, and black rice extract.
Dietary Supplement: Flavonoids+Prebiotics
A combination of blueberry extract, black current extract, black rice extract, inulin, and fructooligosaccharide.
|
| Experimental: Flavonoids,Flavonoids+Prebiotics,Placebo Participants will receive three treatments, for three weeks each, with 21 day washout period between each product. |
Other: Placebo
A combination of maltodextrins and red and blue food colors.
Dietary Supplement: Flavonoids
A combination of blueberry extract, black current extract, and black rice extract.
Dietary Supplement: Flavonoids+Prebiotics
A combination of blueberry extract, black current extract, black rice extract, inulin, and fructooligosaccharide.
|
| Experimental: Flavonoids+Prebiotics,Placebo,Flavonoids Participants will receive three treatments, for three weeks each, with 21 day washout period between each product. |
Other: Placebo
A combination of maltodextrins and red and blue food colors.
Dietary Supplement: Flavonoids
A combination of blueberry extract, black current extract, and black rice extract.
Dietary Supplement: Flavonoids+Prebiotics
A combination of blueberry extract, black current extract, black rice extract, inulin, and fructooligosaccharide.
|
| Experimental: Flavonoids+Prebiotics,Flavonoids,Placebo Participants will receive three treatments, for three weeks each, with 21 day washout period between each product. |
Other: Placebo
A combination of maltodextrins and red and blue food colors.
Dietary Supplement: Flavonoids
A combination of blueberry extract, black current extract, and black rice extract.
Dietary Supplement: Flavonoids+Prebiotics
A combination of blueberry extract, black current extract, black rice extract, inulin, and fructooligosaccharide.
|
Outcome Measures
Primary Outcome Measures
- Change from baseline in fecal volatile methyl sulfides at day 21, day 63, day 105 [baseline, day 21, day 63, day 105]
assessed by gas chromatograph - mass spectrometry (GC-MS) headspace analysis
Secondary Outcome Measures
- Change from baseline in all fecal VOCs at day 21, day 63, day 105 [baseline, day 21, day 63, day 105]
- Change from baseline fecal short chain fatty acids at day 21, day 63, day 105 [baseline, day 21, day 63, day 105]
- Change from baseline fecal microbiota composition at day 21, day 63, day 105 [baseline, day 21, day 63, day 105]
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Male or female of any race or ethnicity between 18 to 70 years of age, inclusive;
-
Body mass index (BMI) between 20 - 32 inclusive;
-
Non-smoking status;
-
Willing to consume assigned dietary supplements for a total of 6 weeks;
-
Have access to email and a digital camera or camera phone.
Exclusion Criteria:
-
Age <18 or >70 years;
-
BMI <20 or >32;
-
Uncontrolled hypertension defined as diastolic blood pressure ≥95 mm Hg or systolic blood pressure ≥160 mm Hg;
-
Self-reported presence of atherosclerotic disease and/or cardiopulmonary disease;
-
Renal, hepatic, endocrine, gastrointestinal or other systemic disease;
-
For women, pregnancy, breast feeding or postpartum less than 6 months;
-
Current participation in another research study;
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Allergy to the components in the dietary supplement (inulin, fructooligosaccharide, blueberries, black currant, rice);
-
History of drug or alcohol abuse;
-
Use of antibiotics within the last 6 months;
-
Use of prebiotics or flavonoid-containing dietary supplements within the last 30 days;
-
Multiple food allergies or significant food preferences or restrictions that would interfere with diet adherence;
-
Chronic use of over-the-counter medication which would interfere with study endpoints including NSAIDS, laxatives and antacids;
-
Participating in or planning to begin a weight loss diet during the study period;
-
Lifestyle or schedule incompatible with the study protocol;
-
Other medical, psychiatric, or behavioral conditions that in the view of the principal investigator may present a safety hazard to the participant or interfere with study participation or the ability to follow the intervention protocol;
-
Use of tobacco products.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Utah State University | Logan | Utah | United States | 84322 |
Sponsors and Collaborators
- Pharmanex
- Utah State University
Investigators
- Principal Investigator: Michael Lefevre, PhD, Utah State University
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 16-PHX-0003