Role of Dairy Products in Weight Maintenance
1 other identifier
interventional
338
1 country
2
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 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable obesity
Started Nov 2003
Typical duration for not_applicable obesity
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2003
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2007
CompletedFirst Submitted
Initial submission to the registry
May 27, 2008
CompletedFirst Posted
Study publicly available on registry
May 29, 2008
CompletedMay 29, 2008
May 1, 2008
3.3 years
May 27, 2008
May 28, 2008
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Body weight change
6 months
Body Fat Change
6 months
Study Arms (2)
1
ACTIVE COMPARATORLow Dairy
2
EXPERIMENTALAdequate Dairy
Interventions
Eligibility Criteria
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Tennesseelead
- National Dairy Councilcollaborator
- University of Kansascollaborator
Study Sites (2)
University of Kansas
Lawrence, Kansas, 66045, United States
The University of Tennessee
Knoxville, Tennessee, 37996-1920, United States
Related Publications (2)
Zemel MB, Sun X, Sobhani T, Wilson B. Effects of dairy compared with soy on oxidative and inflammatory stress in overweight and obese subjects. Am J Clin Nutr. 2010 Jan;91(1):16-22. doi: 10.3945/ajcn.2009.28468. Epub 2009 Nov 4.
PMID: 19889829DERIVEDZemel MB, Donnelly JE, Smith BK, Sullivan DK, Richards J, Morgan-Hanusa D, Mayo MS, Sun X, Cook-Wiens G, Bailey BW, Van Walleghen EL, Washburn RA. Effects of dairy intake on weight maintenance. Nutr Metab (Lond). 2008 Oct 24;5:28. doi: 10.1186/1743-7075-5-28.
PMID: 18950508DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Michael B Zemel, PhD
University of Tennessee
- PRINCIPAL INVESTIGATOR
Joseph E Donnelly, PhD
University of Kansas
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
May 27, 2008
First Posted
May 29, 2008
Study Start
November 1, 2003
Primary Completion
February 1, 2007
Study Completion
July 1, 2007
Last Updated
May 29, 2008
Record last verified: 2008-05