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

University of Wisconsin (UW)

Status: Completed

Conditions: Intestinal Barrier Function; Chronic Inflammation

Treatments: Other: Soy pudding; Other: Low fat dairy yogurt

Study type: Interventional

Funder types: Other

Identifiers

NCT01686204

2014-0669

Details and patient eligibility

About

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.

Enrollment: 128 patients

Sex: Female

Ages: 21 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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128 participants in 2 patient groups

Non-obese individuals

Active Comparator group

Description:

Daily consumption of 12 oz lowfat yogurt or soy pudding for 9 weeks.

Treatment:

Other: Soy pudding

Other: Low fat dairy yogurt

Obese individuals

Experimental group

Description:

Consumption of 12 oz of soy pudding or low fat dairy yogurt daily for 9 weeks.

Treatment:

Other: Soy pudding

Other: Low fat dairy yogurt