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

Study Overview
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Brief Summary
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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.

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

Conditions
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Intestinal Barrier Function, Chronic Inflammation

Intervention / Treatment
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* Other: Low fat dairy yogurt
* Other: Soy pudding


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Non-obese individuals<br>Daily consumption of 12 oz lowfat yogurt or soy pudding for 9 weeks. | Other: Low fat dairy yogurt<br>* Consumption of 12 oz of low fat dairy yogurt daily for 9 weeks<br>Other: Soy pudding<br>* Consumption of 12 oz of low fat soy pudding daily for 9 weeks.<br>|
| Experimental: Obese individuals<br>Consumption of 12 oz of soy pudding or low fat dairy yogurt daily for 9 weeks. | Other: Low fat dairy yogurt<br>* Consumption of 12 oz of low fat dairy yogurt daily for 9 weeks<br>Other: Soy pudding<br>* Consumption of 12 oz of low fat soy pudding daily for 9 weeks.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plasma soluble cluster of differentiation 14 (sCD14) | Fasting plasma sCD14 (change from baseline) | 0, 3, 6, and 9 wk | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Yogurt, Intestine, Inflammation, Obese