Yogurt for Prevention of Chronic Inflammation

Anti-inflammatory Activity of Yogurt Mediated by the Intestine

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.

Study Overview

• Status: Completed
• Conditions: Inflammation; Obesity
• Intervention / Treatment: Other: Yogurt; Other: Control food

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Wisconsin
    • Madison, Wisconsin, United States, 53706
      • Department of Food Science, Babcock Hall

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 55 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in systolic blood pressure	Change in resting systolic blood pressure (change in control vs. change in yogurt)	Baseline, Week 4, Week 8, Week 12
Change in diastolic blood pressure	Change in resting diastolic blood pressure (change in control vs. change in yogurt)	Baseline, Week 4, Week 8, Week 12
Change in BMI	Body mass index (change in control vs. change in yogurt)	Baseline, Week 4, Week 8, Week 12
Change in Weight	Change in body weight (change in control vs. change in yogurt)	Baseline, Week 4, Week 8, Week 12
Change in waist circumference	Change in waist circumference (change in control vs. change in yogurt)	Baseline, Week 4, Week 8, Week 12
Compliance: Number of lids and Unused Containers	Number of lids and unused containers of intervention foods (control vs. yogurt)	Baseline, Week 4, Week 8, Week 12
Dietary records	Comparison of dietary records (control vs. yogurt)	2 Weeks Prior to Intervention, Weeks 0-4, Weeks 4-8, Weeks 8-12
Change in gut microbiota diversity	Change in gut microbiota beta diversity (change in control vs. change in yogurt)	Baseline, Week 4, Week 8, Week 12
Change in fecal water ex vivo barrier disrupting activity	Change in barrier disrupting activity of fecal water applied to cultured Caco-2 cells (change in control vs. change in yogurt)	Baseline, Week 4, Week 8, Week 12
Change in fecal total organic carbon	Change in total organic carbon (change in control vs. change in yogurt)	Baseline, Week 4, Week 8, Week 12
Change in fecal butyrate	Change in fecal butyrate (change in control vs. change in yogurt)	Baseline, Week 4, Week 8, Week 12
Change in fecal propionate	Change in fecal propionate (change in control vs. change in yogurt)	Baseline, Week 4, Week 8, Week 12
Change in fecal acetate	Change in fecal acetate (change in control vs. change in yogurt)	Baseline, Week 4, Week 8, Week 12
Change in fecal bile acid (deoxycholic acid)	Change in fecal deoxycholic acid (change in control vs. change in yogurt)	Baseline, Week 4, Week 8, Week 12
Change in fecal bile acid (lithocholic acid)	Change in fecal lithocholic acid (change in control vs. change in yogurt)	Baseline, Week 4, Week 8, Week 12
Change in fecal bile acid (hyodeoxycholic acid)	Change in fecal hyodeoxycholic acid (change in control vs. change in yogurt)	Baseline, Week 4, Week 8, Week 12
Change in fecal bile acid (3β,12α-Dihydroxy-5β-cholan-24-oic acid)	Change in fecal 3β,12α-Dihydroxy-5β-cholan-24-oic acid (change in control vs. change in yogurt)	Baseline, Week 4, Week 8, Week 12

Collaborators and Investigators

• Sponsor: University of Wisconsin, Madison
• Collaborators: University of Massachusetts, Amherst; National Dairy Council
• Investigators: Principal Investigator: Bradley W Bolling, PhD, University of Wisconsin, Madison

Study record dates

Study Major Dates

• Study Start (Actual): October 15, 2021
• Primary Completion (Actual): September 1, 2022
• Study Completion (Actual): September 1, 2022

Study Registration Dates

• First Submitted: October 29, 2019
• First Submitted That Met QC Criteria: October 30, 2019
• First Posted (Actual): November 4, 2019

Study Record Updates

• Last Update Posted (Actual): November 16, 2022
• Last Update Submitted That Met QC Criteria: November 15, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Keywords: obesity; yogurt; intestine
• Additional Relevant MeSH Terms: Pathologic Processes; Inflammation
• Other Study ID Numbers: 2018-1262; A074000 (Other Identifier: UW Madison); AG&LSC/FOOD SCIENCE/FOOD SCIEN (Other Identifier: UW Madison); Protocol Version 1/10/2019 (Other Identifier: UW Madison)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No