Role of Dairy Products in Weight Maintenance

Completed · Not applicable

Conditions studied: Obesity, Weight Gain

In brief

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 subjects will undergo a meal-replacement-based weight loss plan designed to produce a 10 kg weight loss in 8-12 weeks. Upon achieving the weight loss goal, subjects will be randomly assigned to either a low-dairy or high-dairy eucaloric weight maintenance diet for two years. Macronutrient distribution will be maintained constant and set at approximately the U.S. average. Primary outcomes include changes in body weight, body fat and anatomical distribution of fat (via dual x-ray absorptiometry) and resting metabolic rate and substrate oxidation (via respiratory calorimetry); Secondary outcomes include blood pressure, circulating glucose, insulin, lipids and calcitrophic hormones. on prevention of weight regain in humans has not yet been assessed in clinical trials.

Key facts

Study ID

NCT00686426

Run by

University of Tennessee

People needed

338

Starts

2003-11-01

Expected to finish

2007-07-01

Last updated by the study team

2008-05-29

Who can join

Age: 25 and older, up to 50. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• University of Kansas — Lawrence, Kansas, United States
• The University of Tennessee — Knoxville, Tennessee, United States

Full record on ClinicalTrials.gov

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