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Yogurt for Prevention of Chronic Inflammation

Primary Purpose

Obesity, Inflammation

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Yogurt
Control food
Sponsored by
University of Wisconsin, Madison
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Obesity focused on measuring yogurt, obesity, intestine

Eligibility Criteria

21 Years - 55 Years (Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • Department of Food Science, Babcock Hall

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Yogurt-Control

Control-Yogurt

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Change in Th17 proportion
Change in proportions of circulating Th17 cells (change in control vs. change in yogurt)

Secondary Outcome Measures

Change in Treg proportion
Change in proportion of circulating Treg cells (change in control vs. change in yogurt)
Change in Treg subpopulation
Change in proportion of circulating Treg subpopulation (FoxP3+ IL-10+) (change in control vs. change in yogurt)
Change in Th17 subpopulation (IL-17A+ TNFα+)
Change in proportion of circulating Th17 subpopulation (IL-17A+ TNFα+) (change in control vs. change in yogurt)
Change in Th17 subpopulation (IL-17A+ IFNδ+)
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+)
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+)
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+)
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)
Change in fasting plasma TNF-alpha (change in control vs. change in yogurt)
Change in plasma interferon gamma (IFN-gamma)
Change in fasting plasma IFN-gamma (change in control vs. change in yogurt)
Change in plasma interleukin-6 (IL-6)
Change in fasting plasma IL-6 (change in control vs. change in yogurt)
Change in plasma interleukin-17A (IL-17A)
Change in fasting plasma IL-17A (change in control vs. change in yogurt)
Change in plasma interleukin-4
Change in fasting plasma IL-4 (change in control vs. change in yogurt)
Change in plasma interleukin-22 (IL-22)
Change in fasting plasma IL-22 (change in control vs. change in yogurt)
Change in plasma interleukin-10 (IL-10)
Change in fasting plasma IL-10 (change in control vs. change in yogurt)
Change in plasma transforming growth factor beta (TGF-beta)
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
Change in fasting plasma RORgammaT expression (change in control vs. change in yogurt)
Change in Forkhead box P3 (FoxP3) expression
Change in fasting FoxP3 expression (change in control vs. change in yogurt)
Change in fecal calprotectin
Change in fecal calprotectin (change in control vs. change in yogurt)
Change in fecal tumor necrosis factor alpha (TNF-alpha)
Change in fecal TNF-alpha (change in control vs. change in yogurt)
Change in fecal interleukin 1 alpha (IL-1alpha)
Change in fecal IL-1alpha (change in control vs. change in yogurt)
Change in fecal interleukin 1beta (IL-1beta)
Change in fecal IL-1beta (change in control vs. change in yogurt)
Change in fecal interleukin-6 (IL-6)
Change in fecal IL-6 (change in control vs. change in yogurt)
Change in fecal interleukin-17A (IL-17A)
Change in fecal IL-17A (change in control vs. change in yogurt)

Full Information

First Posted
October 29, 2019
Last Updated
November 15, 2022
Sponsor
University of Wisconsin, Madison
Collaborators
National Dairy Council, University of Massachusetts, Amherst
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1. Study Identification

Unique Protocol Identification Number
NCT04149418
Brief Title
Yogurt for Prevention of Chronic Inflammation
Official Title
Anti-inflammatory Activity of Yogurt Mediated by the Intestine
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Completed
Study Start Date
October 15, 2021 (Actual)
Primary Completion Date
September 1, 2022 (Actual)
Study Completion Date
September 1, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Wisconsin, Madison
Collaborators
National Dairy Council, University of Massachusetts, Amherst

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Inflammation
Keywords
yogurt, obesity, intestine

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Yogurt-Control
Arm Type
Experimental
Arm Description
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.
Arm Title
Control-Yogurt
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Yogurt
Intervention Description
Low-fat flavored yogurt
Intervention Type
Other
Intervention Name(s)
Control food
Intervention Description
Low-fat flavored soy pudding
Primary Outcome Measure Information:
Title
Change in Th17 proportion
Description
Change in proportions of circulating Th17 cells (change in control vs. change in yogurt)
Time Frame
Baseline, Week 4, Week 8, Week 12
Secondary Outcome Measure Information:
Title
Change in Treg proportion
Description
Change in proportion of circulating Treg cells (change in control vs. change in yogurt)
Time Frame
Baseline, Week 4, Week 8, Week 12
Title
Change in Treg subpopulation
Description
Change in proportion of circulating Treg subpopulation (FoxP3+ IL-10+) (change in control vs. change in yogurt)
Time Frame
Baseline, Week 4, Week 8, Week 12
Title
Change in Th17 subpopulation (IL-17A+ TNFα+)
Description
Change in proportion of circulating Th17 subpopulation (IL-17A+ TNFα+) (change in control vs. change in yogurt)
Time Frame
Baseline, Week 4, Week 8, Week 12
Title
Change in Th17 subpopulation (IL-17A+ IFNδ+)
Description
Change in proportion of circulating Th17 subpopulation (IL-17A+ IFNδ+) (change in control vs. change in yogurt)
Time Frame
Baseline, Week 4, Week 8, Week 12
Title
Change in Th17 subpopulation (IL-17A+ IL-22+)
Description
Change in proportion of circulating Th17 subpopulation (IL-17A+ IL-22+) (change in control vs. change in yogurt)
Time Frame
Baseline, Week 4, Week 8, Week 12
Title
Change in Th17 subpopulation (IL-17A+ FoxP3+)
Description
Change in proportion of circulating Th17 subpopulation (IL-17A+ FoxP3+) (change in control vs. change in yogurt)
Time Frame
Baseline, Week 4, Week 8, Week 12
Title
Change in Th17 subpopulation (IL-17A+ IL-10+)
Description
Change in proportion of circulating Th17 subpopulation (IL-17A+ IL-10+) (change in control vs. change in yogurt)
Time Frame
Baseline, Week 4, Week 8, Week 12
Title
Change in plasma tumor necrosis factor alpha (TNF-alpha)
Description
Change in fasting plasma TNF-alpha (change in control vs. change in yogurt)
Time Frame
Baseline, Week 4, Week 8, Week 12
Title
Change in plasma interferon gamma (IFN-gamma)
Description
Change in fasting plasma IFN-gamma (change in control vs. change in yogurt)
Time Frame
Baseline, Week 4, Week 8, Week 12
Title
Change in plasma interleukin-6 (IL-6)
Description
Change in fasting plasma IL-6 (change in control vs. change in yogurt)
Time Frame
Baseline, Week 4, Week 8, Week 12
Title
Change in plasma interleukin-17A (IL-17A)
Description
Change in fasting plasma IL-17A (change in control vs. change in yogurt)
Time Frame
Baseline, Week 4, Week 8, Week 12
Title
Change in plasma interleukin-4
Description
Change in fasting plasma IL-4 (change in control vs. change in yogurt)
Time Frame
Baseline, Week 4, Week 8, Week 12
Title
Change in plasma interleukin-22 (IL-22)
Description
Change in fasting plasma IL-22 (change in control vs. change in yogurt)
Time Frame
Baseline, Week 4, Week 8, Week 12
Title
Change in plasma interleukin-10 (IL-10)
Description
Change in fasting plasma IL-10 (change in control vs. change in yogurt)
Time Frame
Baseline, Week 4, Week 8, Week 12
Title
Change in plasma transforming growth factor beta (TGF-beta)
Description
Change in fasting plasma TGF-beta (change in control vs. change in yogurt)
Time Frame
Baseline, Week 4, Week 8, Week 12
Title
Change in retinoic acid receptor-related orphan nuclear receptor gamma T (RORgammaT) expression
Description
Change in fasting plasma RORgammaT expression (change in control vs. change in yogurt)
Time Frame
Baseline, Week 4, Week 8, Week 12
Title
Change in Forkhead box P3 (FoxP3) expression
Description
Change in fasting FoxP3 expression (change in control vs. change in yogurt)
Time Frame
Baseline, Week 4, Week 8, Week 12
Title
Change in fecal calprotectin
Description
Change in fecal calprotectin (change in control vs. change in yogurt)
Time Frame
Baseline, Week 4, Week 8, Week 12
Title
Change in fecal tumor necrosis factor alpha (TNF-alpha)
Description
Change in fecal TNF-alpha (change in control vs. change in yogurt)
Time Frame
Baseline, Week 4, Week 8, Week 12
Title
Change in fecal interleukin 1 alpha (IL-1alpha)
Description
Change in fecal IL-1alpha (change in control vs. change in yogurt)
Time Frame
Baseline, Week 4, Week 8, Week 12
Title
Change in fecal interleukin 1beta (IL-1beta)
Description
Change in fecal IL-1beta (change in control vs. change in yogurt)
Time Frame
Baseline, Week 4, Week 8, Week 12
Title
Change in fecal interleukin-6 (IL-6)
Description
Change in fecal IL-6 (change in control vs. change in yogurt)
Time Frame
Baseline, Week 4, Week 8, Week 12
Title
Change in fecal interleukin-17A (IL-17A)
Description
Change in fecal IL-17A (change in control vs. change in yogurt)
Time Frame
Baseline, Week 4, Week 8, Week 12
Other Pre-specified Outcome Measures:
Title
Change in systolic blood pressure
Description
Change in resting systolic blood pressure (change in control vs. change in yogurt)
Time Frame
Baseline, Week 4, Week 8, Week 12
Title
Change in diastolic blood pressure
Description
Change in resting diastolic blood pressure (change in control vs. change in yogurt)
Time Frame
Baseline, Week 4, Week 8, Week 12
Title
Change in BMI
Description
Body mass index (change in control vs. change in yogurt)
Time Frame
Baseline, Week 4, Week 8, Week 12
Title
Change in Weight
Description
Change in body weight (change in control vs. change in yogurt)
Time Frame
Baseline, Week 4, Week 8, Week 12
Title
Change in waist circumference
Description
Change in waist circumference (change in control vs. change in yogurt)
Time Frame
Baseline, Week 4, Week 8, Week 12
Title
Compliance: Number of lids and Unused Containers
Description
Number of lids and unused containers of intervention foods (control vs. yogurt)
Time Frame
Baseline, Week 4, Week 8, Week 12
Title
Dietary records
Description
Comparison of dietary records (control vs. yogurt)
Time Frame
2 Weeks Prior to Intervention, Weeks 0-4, Weeks 4-8, Weeks 8-12
Title
Change in gut microbiota diversity
Description
Change in gut microbiota beta diversity (change in control vs. change in yogurt)
Time Frame
Baseline, Week 4, Week 8, Week 12
Title
Change in fecal water ex vivo barrier disrupting activity
Description
Change in barrier disrupting activity of fecal water applied to cultured Caco-2 cells (change in control vs. change in yogurt)
Time Frame
Baseline, Week 4, Week 8, Week 12
Title
Change in fecal total organic carbon
Description
Change in total organic carbon (change in control vs. change in yogurt)
Time Frame
Baseline, Week 4, Week 8, Week 12
Title
Change in fecal butyrate
Description
Change in fecal butyrate (change in control vs. change in yogurt)
Time Frame
Baseline, Week 4, Week 8, Week 12
Title
Change in fecal propionate
Description
Change in fecal propionate (change in control vs. change in yogurt)
Time Frame
Baseline, Week 4, Week 8, Week 12
Title
Change in fecal acetate
Description
Change in fecal acetate (change in control vs. change in yogurt)
Time Frame
Baseline, Week 4, Week 8, Week 12
Title
Change in fecal bile acid (deoxycholic acid)
Description
Change in fecal deoxycholic acid (change in control vs. change in yogurt)
Time Frame
Baseline, Week 4, Week 8, Week 12
Title
Change in fecal bile acid (lithocholic acid)
Description
Change in fecal lithocholic acid (change in control vs. change in yogurt)
Time Frame
Baseline, Week 4, Week 8, Week 12
Title
Change in fecal bile acid (hyodeoxycholic acid)
Description
Change in fecal hyodeoxycholic acid (change in control vs. change in yogurt)
Time Frame
Baseline, Week 4, Week 8, Week 12
Title
Change in fecal bile acid (3β,12α-Dihydroxy-5β-cholan-24-oic acid)
Description
Change in fecal 3β,12α-Dihydroxy-5β-cholan-24-oic acid (change in control vs. change in yogurt)
Time Frame
Baseline, Week 4, Week 8, Week 12

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
Female
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bradley W Bolling, PhD
Organizational Affiliation
University of Wisconsin, Madison
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Food Science, Babcock Hall
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53706
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Yogurt for Prevention of Chronic Inflammation

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