Overview

This trial is active, not recruiting.

Conditions intestinal barrier function, chronic inflammation
Treatments low fat dairy yogurt, soy pudding
Sponsor University of Wisconsin, Madison
Collaborator Dairy Research Institute
Start date September 2012
End date December 2016
Trial size 132 participants
Trial identifier NCT01686204, 2014-0669

Summary

The main objective of this work is to conduct a clinical trial in obese and non-obese individuals testing the ability of low-fat dairy yogurt to improve gastrointestinal health and reduce chronic inflammation. Our central hypothesis is that short and long-term consumption of low-fat dairy yogurt will reduce inflammation to a greater extent in obese individuals by improving intestinal barrier function.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking open label
Primary purpose basic science
Arm
(Active Comparator)
Daily consumption of 12 oz lowfat yogurt or soy pudding for 9 weeks.
low fat dairy yogurt
Consumption of 12 oz of low fat dairy yogurt daily for 9 weeks
soy pudding
Consumption of 12 oz of low fat soy pudding daily for 9 weeks.
(Experimental)
Consumption of 12 oz of soy pudding or low fat dairy yogurt daily for 9 weeks.
low fat dairy yogurt
Consumption of 12 oz of low fat dairy yogurt daily for 9 weeks
soy pudding
Consumption of 12 oz of low fat soy pudding daily for 9 weeks.

Primary Outcomes

Measure
Plasma soluble cluster of differentiation 14 (sCD14)
time frame: Change from baseline at 3, 6, and 9 weeks

Secondary Outcomes

Measure
Plasma Interleukin (IL)-6
time frame: Baseline, 3, 6, 9 weeks

Eligibility Criteria

Female participants from 21 years up to 55 years old.

Inclusion Criteria: - premenopausal women - BMI from 18.5-27 and 30-40 kg/m2 - resting blood pressure <140/90 mmHg - not taking medication to control hypertension - stable body weight for the previous 2 months - willing to maintain a normal exercise level and avoid exercise 24 h prior to blood sampling - willing to avoid yogurt and probiotic-containing foods or consume 2 servings of yogurt for the duration of the study Exclusion Criteria: - previous diagnoses of cardiovascular disease (CVD), diabetes, or arthritis (except for osteo-arthritis) - currently being treated for cancer (i.e., chemotherapy, radiation therapy) - prescribed estrogen replacement therapy - practicing weight-loss, vegetarian, kosher, or vegan diets - currently taking dietary supplements - exceed alcohol consumption more than moderate drinking (1 drink/day or a total of 7/week) - actively using antibiotics - taking anti-inflammatory drugs - have allergies to soy, egg or milk - perimenopausal or menopausal symptoms

Additional Information

Official title Reduction of Obesity-Associated Intestinal Inflammation by Low-Fat Dairy Yogurt
Principal investigator Bradley W Bolling, PhD
Trial information was received from ClinicalTrials.gov and was last updated in May 2016.
Information provided to ClinicalTrials.gov by University of Wisconsin, Madison.