Yogurt for Prevention of Chronic Inflammation

NCT04149418 | Completed

• 4 other identifiers: 2018-1262A074000AG&LSC/FOOD SCIENCE/FOOD SCIENProtocol Version 1/10/2019
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity; Inflammation

Keywords

yogurt; obesity; intestine

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (23)

• Change in Treg proportion

  Baseline, Week 4, Week 8, Week 12

• Change in Treg subpopulation

  Baseline, Week 4, Week 8, Week 12

• Change in Th17 subpopulation (IL-17A+ TNFα+)

  Baseline, Week 4, Week 8, Week 12

• Change in Th17 subpopulation (IL-17A+ IFNδ+)

  Baseline, Week 4, Week 8, Week 12

• Change in Th17 subpopulation (IL-17A+ IL-22+)

  Baseline, Week 4, Week 8, Week 12

Other Outcomes (17)

• Change in systolic blood pressure

  Baseline, Week 4, Week 8, Week 12

• Change in diastolic blood pressure

  Baseline, Week 4, Week 8, Week 12

• Change in BMI

  Baseline, Week 4, Week 8, Week 12

Study Arms (2)

Yogurt-Control

EXPERIMENTAL

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; Other: Control food

Control-Yogurt

EXPERIMENTAL

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; Other: Control food

Interventions

Yogurt OTHER

Low-fat flavored yogurt

Control-Yogurt; Yogurt-Control

Control food OTHER

Low-fat flavored soy pudding

Control-Yogurt; Yogurt-Control

Eligibility Criteria

• Age: 21 Years - 55 Years
• Gender Eligibility Details: Female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Wisconsin, Madison: lead
• National Dairy Council: collaborator
• University of Massachusetts, Amherst: collaborator

Study Sites (1)

Department of Food Science, Babcock Hall

Madison, Wisconsin, 53706, United States

Location

Related Publications (1)

• Hasegawa Y, Noll AL, Lang DJ, Akfaly EM, Liu Z, Bolling BW. Low-fat yogurt consumption maintains biomarkers of immune function relative to nondairy control food in women with elevated BMI: A randomized controlled crossover trial. Nutr Res. 2024 Sep;129:1-13. doi: 10.1016/j.nutres.2024.07.005. Epub 2024 Jul 24.

  PMID: 39153426 DERIVED

MeSH Terms

Conditions

Obesity; Inflammation

Interventions

Yogurt; Hazard Analysis and Critical Control Points

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pathologic Processes

Intervention Hierarchy (Ancestors)

Cultured Milk Products; Milk; Beverages; Diet, Food, and Nutrition; Physiological Phenomena; Fermented Foods; Dairy Products; Food; Food and Beverages; Food Safety; Food Quality; Food Technology; Food Industry; Industry; Technology, Industry, and Agriculture; Safety; Accident Prevention; Accidents; Public Health; Environment and Public Health

Study Officials

• Bradley W Bolling, PhD

  University of Wisconsin, Madison

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 29, 2019
• First Posted: November 4, 2019
• Study Start: October 15, 2021
• Primary Completion: September 1, 2022
• Study Completion: September 1, 2022
• Last Updated: November 16, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)