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

This study is currently recruiting participants.
Verified October 2013 by University of Connecticut
Sponsor:
Collaborator:
Dairy Research Institute
Information provided by (Responsible Party):
Bradley Bolling, University of Connecticut
ClinicalTrials.gov Identifier:
NCT01686204
First received: September 12, 2012
Last updated: October 23, 2013
Last verified: October 2013
  Purpose

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.


Condition Intervention
Intestinal Barrier Function
Chronic Inflammation
Other: Low fat dairy yogurt
Other: Soy pudding

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: Reduction of Obesity-Associated Intestinal Inflammation by Low-Fat Dairy Yogurt

Resource links provided by NLM:


Further study details as provided by University of Connecticut:

Primary Outcome Measures:
  • Plasma sCD14 [ Time Frame: Change from baseline at 3, 6, and 9 weeks ] [ Designated as safety issue: No ]
    Following a high fat, high calorie meal at baseline and 9 wk


Secondary Outcome Measures:
  • Plasma IL-6 [ Time Frame: Baseline, 3, 6, 9 weeks ] [ Designated as safety issue: No ]
    Following a high fat, high calorie meal at baseline and 9 wk


Other Outcome Measures:
  • Monocyte gene expression [ Time Frame: Baseline, 9 weeks ] [ Designated as safety issue: No ]
  • Plasma lipopolysaccharide binding protein [ Time Frame: Baseline, 9 weeks ] [ Designated as safety issue: No ]
  • Plasma endotoxin [ Time Frame: Baseline, 9 weeks ] [ Designated as safety issue: No ]
  • Plasma core antibodies to endotoxin [ Time Frame: Baseline, 9 weeks ] [ Designated as safety issue: No ]
  • Plasma endocannabinoids [ Time Frame: Baseline, 9 weeks ] [ Designated as safety issue: No ]
  • Plasma IL-10 [ Time Frame: Baseline, 9 weeks ] [ Designated as safety issue: No ]
  • Plasma C-reactive protein [ Time Frame: Baseline, 9 weeks ] [ Designated as safety issue: No ]
  • Plasma Tumor Necrosis Factor-alpha [ Time Frame: Baseline, 9 weeks ] [ Designated as safety issue: No ]
  • Plasma tumor necrosis factor receptor [ Time Frame: Baseline, 9 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 132
Study Start Date: September 2012
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Non-obese individuals
Daily consumption of 12 oz lowfat yogurt or soy pudding for 9 weeks.
Other: Low fat dairy yogurt
Consumption of 12 oz of low fat dairy yogurt daily for 9 weeks
Other: Soy pudding
Consumption of 12 oz of low fat soy pudding daily for 9 weeks.
Experimental: Obese individuals
Consumption of 12 oz of soy pudding or low fat dairy yogurt daily for 9 weeks.
Other: Low fat dairy yogurt
Consumption of 12 oz of low fat dairy yogurt daily for 9 weeks
Other: Soy pudding
Consumption of 12 oz of low fat soy pudding daily for 9 weeks.

  Eligibility

Ages Eligible for Study:   21 Years to 55 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01686204

Contacts
Contact: Diana Dimarco 860-420-9841 uconn.yogurt@gmail.com

Locations
United States, Connecticut
Department of Nutritional Sciences Recruiting
Storrs, Connecticut, United States, 06269
Contact: Bradley W Bolling, PhD    860-486-2180    bradley.bolling@uconn.edu   
Principal Investigator: Bradley W Bolling, PhD         
Sponsors and Collaborators
University of Connecticut
Dairy Research Institute
Investigators
Principal Investigator: Bradley W Bolling, PhD University of Connecticut
  More Information

Additional Information:
No publications provided

Responsible Party: Bradley Bolling, Assistant Professor, University of Connecticut
ClinicalTrials.gov Identifier: NCT01686204     History of Changes
Other Study ID Numbers: H12-168
Study First Received: September 12, 2012
Last Updated: October 23, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of Connecticut:
Yogurt
Intestine
Inflammation
Obese

Additional relevant MeSH terms:
Inflammation
Pathologic Processes

ClinicalTrials.gov processed this record on April 16, 2014