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

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 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: May 21, 2014
Last verified: May 2014
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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: May 21, 2014
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 July 29, 2014