Yogurt for Prevention of Chronic Inflammation

Overview

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.

Full Title of Study: “Anti-inflammatory Activity of Yogurt Mediated by the Intestine”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Crossover Assignment
    • Primary Purpose: Basic Science
    • Masking: None (Open Label)
  • Study Primary Completion Date: September 1, 2022

Interventions

  • Other: Yogurt
    • Low-fat flavored yogurt
  • Other: Control food
    • Low-fat flavored soy pudding

Arms, Groups and Cohorts

  • 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.
  • 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.

Clinical Trial Outcome Measures

Primary Measures

  • Change in Th17 proportion
    • Time Frame: Baseline, Week 4, Week 8, Week 12
    • Change in proportions of circulating Th17 cells (change in control vs. change in yogurt)

Secondary Measures

  • Change in Treg proportion
    • Time Frame: 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
    • Time Frame: 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+)
    • Time Frame: 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+)
    • Time Frame: 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+)
    • Time Frame: 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+)
    • Time Frame: 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+)
    • Time Frame: 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)
    • Time Frame: 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)
    • Time Frame: 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)
    • Time Frame: 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)
    • Time Frame: 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
    • Time Frame: 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)
    • Time Frame: 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)
    • Time Frame: 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)
    • Time Frame: 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
    • Time Frame: 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
    • Time Frame: Baseline, Week 4, Week 8, Week 12
    • Change in fasting FoxP3 expression (change in control vs. change in yogurt)
  • Change in fecal calprotectin
    • Time Frame: 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)
    • Time Frame: 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)
    • Time Frame: 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)
    • Time Frame: 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)
    • Time Frame: 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)
    • Time Frame: Baseline, Week 4, Week 8, Week 12
    • Change in fecal IL-17A (change in control vs. change in yogurt)

Participating in This Clinical Trial

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

Gender Eligibility: Female

Female

Minimum Age: 21 Years

Maximum Age: 55 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • University of Wisconsin, Madison
  • Collaborator
    • National Dairy Council
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Bradley W Bolling, PhD, Principal Investigator, University of Wisconsin, Madison

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