Yogurt for Prevention of Chronic Inflammation

Not Applicable

Completed

• Conditions: Inflammation; Obesity
• Interventions: Other: Yogurt; Other: Control food

• Registration Number: NCT04149418
• Lead Sponsor: University of Wisconsin, Madison

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-10-29
• Study First Submitted QC: 2019-10-30
• Study First Posted: 2019-11-04
• Study Start: 2021-10-15
• Primary Completion: 2022-09-01
• Study Completion: 2022-09-01
• Status Verified: 2022-11
• Last Update Submitted: 2022-11-15
• Last Update Posted: 2022-11-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Control-Yogurt	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.
Control-Yogurt	Control food	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.
Yogurt-Control	Yogurt	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.
Yogurt-Control	Control food	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.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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+ 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 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 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 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 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 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 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 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 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-4	Baseline, Week 4, Week 8, Week 12	Change in fasting plasma IL-4 (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 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 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+ 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 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 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-17A (IL-17A)	Baseline, Week 4, Week 8, Week 12	Change in fecal IL-17A (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 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 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 fecal interleukin-6 (IL-6)	Baseline, Week 4, Week 8, Week 12	Change in fecal IL-6 (change in control vs. change in yogurt)

Trial Locations

Locations (1)

Department of Food Science, Babcock Hall; 🇺🇸 Madison, Wisconsin, United States