Role of Dairy Products in Weight Maintenance
Primary Purpose
Obesity, Weight Gain
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Dairy Foods
Dairy Foods
Sponsored by
About this trial
This is an interventional prevention trial for Obesity focused on measuring Obesity, Weight gain, regain, dairy, calcium
Eligibility Criteria
Inclusion Criteria:
- 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 Criteria:
- 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
Sites / Locations
- University of Kansas
- The University of Tennessee
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
1
2
Arm Description
Low Dairy
Adequate Dairy
Outcomes
Primary Outcome Measures
Body weight change
Body Fat Change
Secondary Outcome Measures
Full Information
NCT ID
NCT00686426
First Posted
May 27, 2008
Last Updated
May 28, 2008
Sponsor
University of Tennessee
Collaborators
National Dairy Council, University of Kansas
1. Study Identification
Unique Protocol Identification Number
NCT00686426
Brief Title
Role of Dairy Products in Weight Maintenance
Official Title
Role of Dairy Products in Weight Maintenance: Prevention of Weight Regain Following Weight Loss
Study Type
Interventional
2. Study Status
Record Verification Date
May 2008
Overall Recruitment Status
Completed
Study Start Date
November 2003 (undefined)
Primary Completion Date
February 2007 (Actual)
Study Completion Date
July 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
University of Tennessee
Collaborators
National Dairy Council, University of Kansas
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
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-consumption of an energy-dense diet and to increase lipolysis and preserve thermogenesis during caloric restriction, thereby markedly accelerating weight loss. Our studies of the agouti gene demonstrate a key role for intracellular Ca2+ in regulating adipocyte lipid metabolism and triglyceride storage, with increased intracellular Ca2+ resulting in stimulation of lipogenic gene expression and lipogenesis and suppression of lipolysis, resulting in adipocyte lipid filling and increased adiposity. Moreover, the increased calcitriol produced in response to low calcium diets stimulates adipocyte Ca2+ influx and, consequently, promotes adiposity, while higher calcium diets inhibit lipogenesis, promote lipolysis, lipid oxidation and thermogenesis and inhibit diet-induced obesity in mice. Notably, dairy sources of calcium exert markedly greater effects in attenuating weight and fat gain and accelerating fat loss. This augmented effect of dairy products versus supplemental calcium is likely due to additional bioactive compounds in dairy which act synergistically with calcium to attenuate adiposity. These concepts are confirmed by both epidemiological and clinical data which demonstrates that increasing dietary calcium results in significant reductions in adipose tissue mass in obese humans in the absence of caloric restriction and markedly accelerates the weight and body fat loss secondary to caloric restriction, while dairy products exert markedly greater (nearly two-fold compared to calcium supplements) effects. These data indicate an important role for dairy products in both the prevention and treatment of obesity. However, weight maintenance following successful weight loss (i.e. prevention of regain) is at least as important as strategies to initially achieve weight loss, as most individuals who successfully lose weight are not successful in maintaining this weight loss. We have recently demonstrated that ad libitum re-feeding of dairy-rich following weight loss in mice on an energy restricted mice prevented the suppression of adipose tissue lipolysis and fat oxidation that otherwise accompanies such re-feeding and markedly upregulated skeletal muscle fat oxidation. Consequently, although animals re-fed low calcium diets rapidly regained all of the weight and fat that had been lost, animals fed high calcium diets exhibited a shift in energy partitioning and a 50-85% reduction in weight and fat gain; moreover, dairy exerted markedly greater effects than supplemental calcium on weight and fat regain. However, the effect of dairy on prevention of weight regain in humans has not yet been assessed in clinical trials. Accordingly, 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.
340 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Weight Gain
Keywords
Obesity, Weight gain, regain, dairy, calcium
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
338 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Active Comparator
Arm Description
Low Dairy
Arm Title
2
Arm Type
Experimental
Arm Description
Adequate Dairy
Intervention Type
Dietary Supplement
Intervention Name(s)
Dairy Foods
Intervention Description
Adequate dairy (> 3 standard daily servings)
Intervention Type
Dietary Supplement
Intervention Name(s)
Dairy Foods
Intervention Description
< 1 standard dairy serving/day
Primary Outcome Measure Information:
Title
Body weight change
Time Frame
6 months
Title
Body Fat Change
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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 Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael B Zemel, PhD
Organizational Affiliation
University of Tennessee
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Joseph E Donnelly, PhD
Organizational Affiliation
University of Kansas
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Kansas
City
Lawrence
State/Province
Kansas
ZIP/Postal Code
66045
Country
United States
Facility Name
The University of Tennessee
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37996-1920
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
19889829
Citation
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.
Results Reference
derived
PubMed Identifier
18950508
Citation
Zemel 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.
Results Reference
derived
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Role of Dairy Products in Weight Maintenance
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