Yogurt for Prevention of Chronic Inflammation
Study Details
Study Description
Brief Summary
The objective of this study is to conduct a randomized cross-over dietary intervention in adult women who are overweight or obese to compare how yogurt and a control food affect biomarkers of inflammation and intestinal health.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Yogurt-Control Consumption of 12 oz. of low-fat yogurt daily (2 x 6 oz. servings) for 4 weeks, followed by a washout phase for 4 weeks, then consumption of 12 oz. control food (flavored soy pudding, 2 x 6 oz. servings) for 4 weeks. |
Other: Yogurt
Low-fat flavored yogurt
Other: Control food
Low-fat flavored soy pudding
|
| Experimental: Control-Yogurt Consumption of control food (flavored soy pudding, 2 x 6 oz. servings), followed by a washout phase for 4 weeks, then consumption of 12 oz. of low-fat yogurt daily (2 x 6 oz. servings) for 4 weeks. |
Other: Yogurt
Low-fat flavored yogurt
Other: Control food
Low-fat flavored soy pudding
|
Outcome Measures
Primary Outcome Measures
- Change in Th17 proportion [Baseline, Week 4, Week 8, Week 12]
Change in proportions of circulating Th17 cells (change in control vs. change in yogurt)
Secondary Outcome Measures
- Change in Treg proportion [Baseline, Week 4, Week 8, Week 12]
Change in proportion of circulating Treg cells (change in control vs. change in yogurt)
- Change in Treg subpopulation [Baseline, Week 4, Week 8, Week 12]
Change in proportion of circulating Treg subpopulation (FoxP3+ IL-10+) (change in control vs. change in yogurt)
- Change in Th17 subpopulation (IL-17A+ TNFα+) [Baseline, Week 4, Week 8, Week 12]
Change in proportion of circulating Th17 subpopulation (IL-17A+ TNFα+) (change in control vs. change in yogurt)
- Change in Th17 subpopulation (IL-17A+ IFNδ+) [Baseline, Week 4, Week 8, Week 12]
Change in proportion of circulating Th17 subpopulation (IL-17A+ IFNδ+) (change in control vs. change in yogurt)
- Change in Th17 subpopulation (IL-17A+ IL-22+) [Baseline, Week 4, Week 8, Week 12]
Change in proportion of circulating Th17 subpopulation (IL-17A+ IL-22+) (change in control vs. change in yogurt)
- Change in Th17 subpopulation (IL-17A+ FoxP3+) [Baseline, Week 4, Week 8, Week 12]
Change in proportion of circulating Th17 subpopulation (IL-17A+ FoxP3+) (change in control vs. change in yogurt)
- Change in Th17 subpopulation (IL-17A+ IL-10+) [Baseline, Week 4, Week 8, Week 12]
Change in proportion of circulating Th17 subpopulation (IL-17A+ IL-10+) (change in control vs. change in yogurt)
- Change in plasma tumor necrosis factor alpha (TNF-alpha) [Baseline, Week 4, Week 8, Week 12]
Change in fasting plasma TNF-alpha (change in control vs. change in yogurt)
- Change in plasma interferon gamma (IFN-gamma) [Baseline, Week 4, Week 8, Week 12]
Change in fasting plasma IFN-gamma (change in control vs. change in yogurt)
- Change in plasma interleukin-6 (IL-6) [Baseline, Week 4, Week 8, Week 12]
Change in fasting plasma IL-6 (change in control vs. change in yogurt)
- Change in plasma interleukin-17A (IL-17A) [Baseline, Week 4, Week 8, Week 12]
Change in fasting plasma IL-17A (change in control vs. change in yogurt)
- Change in plasma interleukin-4 [Baseline, Week 4, Week 8, Week 12]
Change in fasting plasma IL-4 (change in control vs. change in yogurt)
- Change in plasma interleukin-22 (IL-22) [Baseline, Week 4, Week 8, Week 12]
Change in fasting plasma IL-22 (change in control vs. change in yogurt)
- Change in plasma interleukin-10 (IL-10) [Baseline, Week 4, Week 8, Week 12]
Change in fasting plasma IL-10 (change in control vs. change in yogurt)
- Change in plasma transforming growth factor beta (TGF-beta) [Baseline, Week 4, Week 8, Week 12]
Change in fasting plasma TGF-beta (change in control vs. change in yogurt)
- Change in retinoic acid receptor-related orphan nuclear receptor gamma T (RORgammaT) expression [Baseline, Week 4, Week 8, Week 12]
Change in fasting plasma RORgammaT expression (change in control vs. change in yogurt)
- Change in Forkhead box P3 (FoxP3) expression [Baseline, Week 4, Week 8, Week 12]
Change in fasting FoxP3 expression (change in control vs. change in yogurt)
- Change in fecal calprotectin [Baseline, Week 4, Week 8, Week 12]
Change in fecal calprotectin (change in control vs. change in yogurt)
- Change in fecal tumor necrosis factor alpha (TNF-alpha) [Baseline, Week 4, Week 8, Week 12]
Change in fecal TNF-alpha (change in control vs. change in yogurt)
- Change in fecal interleukin 1 alpha (IL-1alpha) [Baseline, Week 4, Week 8, Week 12]
Change in fecal IL-1alpha (change in control vs. change in yogurt)
- Change in fecal interleukin 1beta (IL-1beta) [Baseline, Week 4, Week 8, Week 12]
Change in fecal IL-1beta (change in control vs. change in yogurt)
- Change in fecal interleukin-6 (IL-6) [Baseline, Week 4, Week 8, Week 12]
Change in fecal IL-6 (change in control vs. change in yogurt)
- Change in fecal interleukin-17A (IL-17A) [Baseline, Week 4, Week 8, Week 12]
Change in fecal IL-17A (change in control vs. change in yogurt)
Other Outcome Measures
- Change in systolic blood pressure [Baseline, Week 4, Week 8, Week 12]
Change in resting systolic blood pressure (change in control vs. change in yogurt)
- Change in diastolic blood pressure [Baseline, Week 4, Week 8, Week 12]
Change in resting diastolic blood pressure (change in control vs. change in yogurt)
- Change in BMI [Baseline, Week 4, Week 8, Week 12]
Body mass index (change in control vs. change in yogurt)
- Change in Weight [Baseline, Week 4, Week 8, Week 12]
Change in body weight (change in control vs. change in yogurt)
- Change in waist circumference [Baseline, Week 4, Week 8, Week 12]
Change in waist circumference (change in control vs. change in yogurt)
- Compliance: Number of lids and Unused Containers [Baseline, Week 4, Week 8, Week 12]
Number of lids and unused containers of intervention foods (control vs. yogurt)
- Dietary records [2 Weeks Prior to Intervention, Weeks 0-4, Weeks 4-8, Weeks 8-12]
Comparison of dietary records (control vs. yogurt)
- Change in gut microbiota diversity [Baseline, Week 4, Week 8, Week 12]
Change in gut microbiota beta diversity (change in control vs. change in yogurt)
- Change in fecal water ex vivo barrier disrupting activity [Baseline, Week 4, Week 8, Week 12]
Change in barrier disrupting activity of fecal water applied to cultured Caco-2 cells (change in control vs. change in yogurt)
- Change in fecal total organic carbon [Baseline, Week 4, Week 8, Week 12]
Change in total organic carbon (change in control vs. change in yogurt)
- Change in fecal butyrate [Baseline, Week 4, Week 8, Week 12]
Change in fecal butyrate (change in control vs. change in yogurt)
- Change in fecal propionate [Baseline, Week 4, Week 8, Week 12]
Change in fecal propionate (change in control vs. change in yogurt)
- Change in fecal acetate [Baseline, Week 4, Week 8, Week 12]
Change in fecal acetate (change in control vs. change in yogurt)
- Change in fecal bile acid (deoxycholic acid) [Baseline, Week 4, Week 8, Week 12]
Change in fecal deoxycholic acid (change in control vs. change in yogurt)
- Change in fecal bile acid (lithocholic acid) [Baseline, Week 4, Week 8, Week 12]
Change in fecal lithocholic acid (change in control vs. change in yogurt)
- Change in fecal bile acid (hyodeoxycholic acid) [Baseline, Week 4, Week 8, Week 12]
Change in fecal hyodeoxycholic acid (change in control vs. change in yogurt)
- Change in fecal bile acid (3β,12α-Dihydroxy-5β-cholan-24-oic acid) [Baseline, Week 4, Week 8, Week 12]
Change in fecal 3β,12α-Dihydroxy-5β-cholan-24-oic acid (change in control vs. change in yogurt)
Eligibility Criteria
Criteria
Inclusion Criteria:
-
healthy premenopausal women age 21-55
-
BMI ≥ 25 kg/m2
-
not taking medication to control hypertension (e.g. anti-hypertensives or diuretics)
-
resting blood pressure <140/90 mmHg
-
stable body weight for past two months
-
willing to maintain a normal exercise level (in general)
-
willing to avoid exercise and smoking (or other forms of nicotine intake) for 24 h prior to blood collection
-
willing to avoid caffeine for 12 h before study visits
-
willing to fast 12 h prior to study visits
-
willing to avoid dietary supplements, yogurt and probiotic-containing foods (as necessary) and consume 12 oz. of yogurt and the control food per day (as necessary) for the duration of the study
Exclusion Criteria:
-
self-reported previous diagnoses of an inflammatory disease (e.g. inflammatory bowel disease, asthma, arthritis), CVD, diabetes, current cancer treatment (i.e., chemotherapy, radiation therapy)
-
have used oral antibiotics in the prior 21 days before sample collection
-
actively trying to lose weight
-
regularly taking anti-inflammatory drugs
-
vegetarian or allergic to soy or dairy
-
are pregnant, lactating, or trying to become pregnant
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Department of Food Science, Babcock Hall | Madison | Wisconsin | United States | 53706 |
Sponsors and Collaborators
- University of Wisconsin, Madison
- National Dairy Council
- University of Massachusetts, Amherst
Investigators
- Principal Investigator: Bradley W Bolling, PhD, University of Wisconsin, Madison
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 2018-1262
- A074000
- AG&LSC/FOOD SCIENCE/FOOD SCIEN
- Protocol Version 1/10/2019