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

NCT ID: NCT01686204

Last Updated: 2017-10-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

128 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-09-30

Study Completion Date

2017-03-31

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.

Detailed Description

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Conditions

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Intestinal Barrier Function Chronic Inflammation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Non-obese individuals

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

Group Type ACTIVE_COMPARATOR

Low fat dairy yogurt

Intervention Type OTHER

Consumption of 12 oz of low fat dairy yogurt daily for 9 weeks

Soy pudding

Intervention Type OTHER

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

Obese individuals

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

Group Type EXPERIMENTAL

Low fat dairy yogurt

Intervention Type OTHER

Consumption of 12 oz of low fat dairy yogurt daily for 9 weeks

Soy pudding

Intervention Type OTHER

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

Interventions

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Low fat dairy yogurt

Consumption of 12 oz of low fat dairy yogurt daily for 9 weeks

Intervention Type OTHER

Soy pudding

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

Intervention Type OTHER

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
Minimum Eligible Age

21 Years

Maximum Eligible Age

55 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Dairy Research Institute

OTHER

Sponsor Role collaborator

University of Wisconsin, Madison

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Bradley W Bolling, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Wisconsin, Madison

Locations

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Department of Food Science, Babcock Hall

Madison, Wisconsin, United States

Site Status

Countries

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United States

References

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Pei R, DiMarco DM, Putt KK, Martin DA, Chitchumroonchokchai C, Bruno RS, Bolling BW. Premeal Low-Fat Yogurt Consumption Reduces Postprandial Inflammation and Markers of Endotoxin Exposure in Healthy Premenopausal Women in a Randomized Controlled Trial. J Nutr. 2018 Jun 1;148(6):910-916. doi: 10.1093/jn/nxy046.

Reference Type DERIVED
PMID: 29767743 (View on PubMed)

Pei R, DiMarco DM, Putt KK, Martin DA, Gu Q, Chitchumroonchokchai C, White HM, Scarlett CO, Bruno RS, Bolling BW. Low-fat yogurt consumption reduces biomarkers of chronic inflammation and inhibits markers of endotoxin exposure in healthy premenopausal women: a randomised controlled trial. Br J Nutr. 2017 Dec;118(12):1043-1051. doi: 10.1017/S0007114517003038. Epub 2017 Nov 28.

Reference Type DERIVED
PMID: 29179781 (View on PubMed)

Other Identifiers

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2014-0669

Identifier Type: -

Identifier Source: org_study_id