Status:
COMPLETED
Dairy Modulation of Oxidative and Inflammatory Stress in Overweight and Obese Subjects
Lead Sponsor:
University of Tennessee
Collaborating Sponsors:
Dairy Management Inc.
Conditions:
Obesity
Overweight
Eligibility:
All Genders
18-50 years
Phase:
NA
Brief Summary
The objective of this study is to determine the acute effects of a dairy supplement compared to a soy supplement on oxidative and inflammatory stress in overweight and obese subjects in the absence of...
Detailed Description
Obesity is associated with sub-clinical chronic oxidative and inflammatory stress, both of which are major contributors to obesity-associated co-morbidities. Calcitriol (1, 25-(OH)2-D3) regulates adip...
Eligibility Criteria
Inclusion
- Body mass index (BMI) 25-29.9 (n=10); 30-34.9 kg/m2 (n=10)
- Age 18-50 years
- Weight stable: no more than 3 kg weight loss during past three months
Exclusion
- BMI \< 25 or \>35
- Type II diabetes requiring the use of any oral antidiabetic agent and/or insulin (because of confounding effects on ROS)
- Adverse response to study foods (lactose intolerance, dairy intolerance, dairy allergy); this will be determined by self-report.
- history or presence of significant metabolic disease which could impact on the results of the study (i.e. endocrine, hepatic, renal disease)
- history of eating disorder
- presence of active gastrointestinal disorders such as malabsorption syndromes
- pregnancy or lactation
- use of obesity pharmacotherapeutic agents within the last 6 months
- use of over-the-counter anti-obesity agents (e.g. those containing phenylpropanalamine, ephedrine and/or caffeine) within the last 6 months
- Recent (current or past 12 weeks) use of any psychotropic medication
- Recent (past four weeks) initiation of an exercise program
- Recent (past twelve weeks) initiation of hormone replacement therapy or change in HRT regimen
- Recent (past twelve weeks) initiation of hormonal birth control or change in hormonal birth control regimen
- Recent (current or past 12 weeks) history of smoking
Key Trial Info
Start Date :
January 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2009
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT00948038
Start Date
January 1 2007
End Date
May 1 2009
Last Update
July 29 2009
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
The University of Tennessee
Knoxville, Tennessee, United States, 37996