Yogurt for Prevention of Chronic Inflammation

Study Overview
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Brief Summary
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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.

Official Title
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Anti-inflammatory Activity of Yogurt Mediated by the Intestine

Conditions
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Obesity, Inflammation

Intervention / Treatment
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* Other: Yogurt
* Other: Control food


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Yogurt-Control<br>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<br>* Low-fat flavored yogurt<br>Other: Control food<br>* Low-fat flavored soy pudding<br>|
| Experimental: Control-Yogurt<br>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<br>* Low-fat flavored yogurt<br>Other: Control food<br>* Low-fat flavored soy pudding<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Th17 proportion | Change in proportions of circulating Th17 cells (change in control vs. change in yogurt) | Baseline, Week 4, Week 8, Week 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Treg proportion | Change in proportion of circulating Treg cells (change in control vs. change in yogurt) | Baseline, Week 4, Week 8, Week 12 | 
| Change in Treg subpopulation | Change in proportion of circulating Treg subpopulation (FoxP3+ IL-10+) (change in control vs. change in yogurt) | Baseline, Week 4, Week 8, Week 12 | 
| Change in Th17 subpopulation (IL-17A+ TNFα+) | Change in proportion of circulating Th17 subpopulation (IL-17A+ TNFα+) (change in control vs. change in yogurt) | Baseline, Week 4, Week 8, Week 12 | 
| Change in Th17 subpopulation (IL-17A+ IFNδ+) | Change in proportion of circulating Th17 subpopulation (IL-17A+ IFNδ+) (change in control vs. change in yogurt) | Baseline, Week 4, Week 8, Week 12 | 
| Change in Th17 subpopulation (IL-17A+ IL-22+) | Change in proportion of circulating Th17 subpopulation (IL-17A+ IL-22+) (change in control vs. change in yogurt) | Baseline, Week 4, Week 8, Week 12 | 
| Change in Th17 subpopulation (IL-17A+ FoxP3+) | Change in proportion of circulating Th17 subpopulation (IL-17A+ FoxP3+) (change in control vs. change in yogurt) | Baseline, Week 4, Week 8, Week 12 | 
| Change in Th17 subpopulation (IL-17A+ IL-10+) | Change in proportion of circulating Th17 subpopulation (IL-17A+ IL-10+) (change in control vs. change in yogurt) | Baseline, Week 4, Week 8, Week 12 | 
| Change in plasma tumor necrosis factor alpha (TNF-alpha) | Change in fasting plasma TNF-alpha (change in control vs. change in yogurt) | Baseline, Week 4, Week 8, Week 12 | 
| Change in plasma interferon gamma (IFN-gamma) | Change in fasting plasma IFN-gamma (change in control vs. change in yogurt) | Baseline, Week 4, Week 8, Week 12 | 
| Change in plasma interleukin-6 (IL-6) | Change in fasting plasma IL-6 (change in control vs. change in yogurt) | Baseline, Week 4, Week 8, Week 12 | 
| Change in plasma interleukin-17A (IL-17A) | Change in fasting plasma IL-17A (change in control vs. change in yogurt) | Baseline, Week 4, Week 8, Week 12 | 
| Change in plasma interleukin-4 | Change in fasting plasma IL-4 (change in control vs. change in yogurt) | Baseline, Week 4, Week 8, Week 12 | 
| Change in plasma interleukin-22 (IL-22) | Change in fasting plasma IL-22 (change in control vs. change in yogurt) | Baseline, Week 4, Week 8, Week 12 | 
| Change in plasma interleukin-10 (IL-10) | Change in fasting plasma IL-10 (change in control vs. change in yogurt) | Baseline, Week 4, Week 8, Week 12 | 
| Change in plasma transforming growth factor beta (TGF-beta) | Change in fasting plasma TGF-beta (change in control vs. change in yogurt) | Baseline, Week 4, Week 8, Week 12 | 
| Change in retinoic acid receptor-related orphan nuclear receptor gamma T (RORgammaT) expression | Change in fasting plasma RORgammaT expression (change in control vs. change in yogurt) | Baseline, Week 4, Week 8, Week 12 | 
| Change in Forkhead box P3 (FoxP3) expression | Change in fasting FoxP3 expression (change in control vs. change in yogurt) | Baseline, Week 4, Week 8, Week 12 | 
| Change in fecal calprotectin | Change in fecal calprotectin (change in control vs. change in yogurt) | Baseline, Week 4, Week 8, Week 12 | 
| Change in fecal tumor necrosis factor alpha (TNF-alpha) | Change in fecal TNF-alpha (change in control vs. change in yogurt) | Baseline, Week 4, Week 8, Week 12 | 
| Change in fecal interleukin 1 alpha (IL-1alpha) | Change in fecal IL-1alpha (change in control vs. change in yogurt) | Baseline, Week 4, Week 8, Week 12 | 
| Change in fecal interleukin 1beta (IL-1beta) | Change in fecal IL-1beta (change in control vs. change in yogurt) | Baseline, Week 4, Week 8, Week 12 | 
| Change in fecal interleukin-6 (IL-6) | Change in fecal IL-6 (change in control vs. change in yogurt) | Baseline, Week 4, Week 8, Week 12 | 
| Change in fecal interleukin-17A (IL-17A) | Change in fecal IL-17A (change in control vs. change in yogurt) | Baseline, Week 4, Week 8, Week 12 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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yogurt, obesity, intestine