Status:
COMPLETED
Role of Dairy Products in Weight Maintenance
Lead Sponsor:
University of Tennessee
Collaborating Sponsors:
National Dairy Council
University of Kansas
Conditions:
Obesity
Weight Gain
Eligibility:
All Genders
25-50 years
Phase:
NA
Brief Summary
The goal of the current study is to determine the role of dairy in similarly preventing weight and fat re-gain in obese adults who have successfully completed a weight loss diet program.240 obese subj...
Detailed Description
Dietary calcium plays a pivotal role in the regulation of energy metabolism, as we have found high calcium diets to attenuate adipocyte lipid accretion and weight gain during periods of over-consumpti...
Eligibility Criteria
Inclusion
- Body mass index (BMI) 30-39.9 kg/m2
- Age 25-50 years
- No more than 3 kg weight loss during past three months
- Negative pregnancy test at entry; women of childbearing potential may be enrolled if they have had a tubal ligation or use one of the following means of contraception: condom, diaphragm, oral or implanted contraceptives, or intrauterine device. Women in exclusive relationships with male partners who have had a successful vasectomy will not be required to use any additional means of birth control.
Exclusion
- BMI \< 30 or \>40
- Type II diabetes requiring the use of any oral antidiabetic agent and/or insulin (because of confounding effects on body weight regulation)
- 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 (past 12 weeks) use of tobacco
- 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
Key Trial Info
Start Date :
November 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2007
Estimated Enrollment :
338 Patients enrolled
Trial Details
Trial ID
NCT00686426
Start Date
November 1 2003
End Date
July 1 2007
Last Update
May 29 2008
Active Locations (2)
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1
University of Kansas
Lawrence, Kansas, United States, 66045
2
The University of Tennessee
Knoxville, Tennessee, United States, 37996-1920