Yogurt for Prevention of Chronic Inflammation

Obesity Clinical Trial

Official title:

Anti-inflammatory Activity of Yogurt Mediated by the Intestine

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04149418
• Other study ID #: 2018-1262
• Secondary ID: A074000AG&LSC/FO
• Status: Completed
• Phase: N/A
• Start date: October 15, 2021
• Est. completion date: September 1, 2022

Study information

• Verified date: November 2022
• Source: University of Wisconsin, Madison
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: September 1, 2022
• Est. primary completion date: September 1, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 21 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Inflammation
• Obesity

Intervention

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

Locations

Country	Name	City	State
United States	Department of Food Science, Babcock Hall	Madison	Wisconsin

Sponsors (3)

Lead Sponsor	Collaborator
University of Wisconsin, Madison	National Dairy Council, University of Massachusetts, Amherst

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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
Other	Change in BMI	Body mass index (change in control vs. change in yogurt)	Baseline, Week 4, Week 8, Week 12
Other	Change in Weight	Change in body weight (change in control vs. change in yogurt)	Baseline, Week 4, Week 8, Week 12
Other	Change in waist circumference	Change in waist circumference (change in control vs. change in yogurt)	Baseline, Week 4, Week 8, Week 12
Other	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
Other	Dietary records	Comparison of dietary records (control vs. yogurt)	2 Weeks Prior to Intervention, Weeks 0-4, Weeks 4-8, Weeks 8-12
Other	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
Other	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
Other	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
Other	Change in fecal butyrate	Change in fecal butyrate (change in control vs. change in yogurt)	Baseline, Week 4, Week 8, Week 12
Other	Change in fecal propionate	Change in fecal propionate (change in control vs. change in yogurt)	Baseline, Week 4, Week 8, Week 12
Other	Change in fecal acetate	Change in fecal acetate (change in control vs. change in yogurt)	Baseline, Week 4, Week 8, Week 12
Other	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
Other	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
Other	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
Other	Change in fecal bile acid (3ß,12a-Dihydroxy-5ß-cholan-24-oic acid)	Change in fecal 3ß,12a-Dihydroxy-5ß-cholan-24-oic acid (change in control vs. change in yogurt)	Baseline, Week 4, Week 8, Week 12
Primary	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	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
Secondary	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
Secondary	Change in Th17 subpopulation (IL-17A+ TNFa+)	Change in proportion of circulating Th17 subpopulation (IL-17A+ TNFa+) (change in control vs. change in yogurt)	Baseline, Week 4, Week 8, Week 12
Secondary	Change in Th17 subpopulation (IL-17A+ IFNd+)	Change in proportion of circulating Th17 subpopulation (IL-17A+ IFNd+) (change in control vs. change in yogurt)	Baseline, Week 4, Week 8, Week 12
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Change in fecal calprotectin	Change in fecal calprotectin (change in control vs. change in yogurt)	Baseline, Week 4, Week 8, Week 12
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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