Reduction of Obesity-Associated Intestinal Inflammation by Low-Fat Dairy Yogurt

Not Applicable

Completed

• Conditions: Intestinal Barrier Function; Chronic Inflammation
• Interventions: Other: Low fat dairy yogurt; Other: Soy pudding

• Registration Number: NCT01686204
• Lead Sponsor: University of Wisconsin, Madison

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-09
• Study First Submitted: 2012-09-12
• Study First Submitted QC: 2012-09-12
• Study First Posted: 2012-09-17
• Primary Completion: 2016-09-30
• Study Completion: 2017-03-31
• Status Verified: 2017-09
• Last Update Submitted: 2017-09-29
• Last Update Posted: 2017-10-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 128

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Obese individuals	Soy pudding	Consumption of 12 oz of soy pudding or low fat dairy yogurt daily for 9 weeks.
Non-obese individuals	Low fat dairy yogurt	Daily consumption of 12 oz lowfat yogurt or soy pudding for 9 weeks.
Non-obese individuals	Soy pudding	Daily consumption of 12 oz lowfat yogurt or soy pudding for 9 weeks.
Obese individuals	Low fat dairy yogurt	Consumption of 12 oz of soy pudding or low fat dairy yogurt daily for 9 weeks.

Primary Outcome Measures

Name	Time	Method
Plasma soluble cluster of differentiation 14 (sCD14)	0, 3, 6, and 9 wk	Fasting plasma sCD14 (change from baseline)

Secondary Outcome Measures

Name	Time	Method
Fasting plasma interleukin-6 (IL-6)	0, 3, 6, 9 wk	Fasting plasma IL-6 (change from baseline)
Postprandial sCD14	0 and 9 wk	Postprandial plasma sCD14 following a high-fat, high-calorie challenge meal (area under curve)
Postprandial interleukin-6 (IL-6)	0 and 9 wk	Postprandial plasma IL-6 following a high-fat, high-calorie challenge meal (area under curve)

Trial Locations

Locations (1)

Department of Food Science, Babcock Hall; 🇺🇸 Madison, Wisconsin, United States