ObesityNCT00686426
Role of Dairy Products in Weight Maintenance
A study testing Dairy Foods in people with Obesity and Weight Gain, run by University of Tennessee at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 25 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity, Weight Gain
- What is being tested?
- Dairy Foods
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 338 participants
- Where
- 2 sitesUnited States
- Study dates
- Nov 2003to Jul 2007
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 14Show fewer
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
The University of Tennessee
Knoxville, Tennessee, 37996-1920
University of Kansas
Lawrence, Kansas, 66045
About this study
Official title: Role of Dairy Products in Weight Maintenance: Prevention of Weight Regain Following Weight Loss
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.
Read the 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.
- Conditions
- Obesity, Weight Gain
- Being tested
- Dairy Foods
- Keywords
- Obesity, Weight gain, regain, dairy, calcium
- Medical subject headings
- Obesity, Weight Gain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dairy FoodsDietary supplement
Adequate dairy (> 3 standard daily servings)
Dairy FoodsDietary supplement
< 1 standard dairy serving/day
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Low Dairy Receives: Dietary Supplement: Dairy Foods |
| 2 | Experimental | Adequate Dairy Receives: Dietary Supplement: Dairy Foods |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body weight change
Measured: 6 months
Body Fat Change
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2008 (estimated)
- Study startNov 2003
- Primary completionFeb 2007
- Study completionJul 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 338 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Tennessee
- Sponsor type
- University, hospital or other
- Collaborators
- National Dairy Council, University of Kansas
- Investigators
- Michael B Zemel, PhD, Principal investigator, University of TennesseeJoseph E Donnelly, PhD, Principal investigator, University of Kansas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00686426
- Sponsor's protocol ID
- DMI-993
- Status last verified
- May 2008
- First submitted
- 27 May 2008
- Last updated
- 29 May 2008
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 19889829Zemel 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.
PubMed 18950508
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Dairy Products in Weight Maintenance: Prevention of Weight Regain Following Weight Loss
- ClinicalTrials.gov ID
- NCT00686426
- Acronym / sponsor ID
- DMI-993
- Conditions
- Obesity, Weight Gain
- Keywords
- Obesity, Weight gain, regain, dairy, calcium
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 338 participants (actual)
- Lead sponsor
- University of TennesseeUniversity, hospital or other
- Collaborators
- National Dairy Council, University of Kansas
- Study start
- Nov 2003
- Primary completion
- Feb 2007 (actual)
- Study completion
- Jul 2007 (actual)
- First posted
- 29 May 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Dietary Supplement: Dairy FoodsLow Dairy |
| 2 | Experimental | Dietary Supplement: Dairy FoodsAdequate Dairy |
Who may qualify
- Ages
- 25 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dairy FoodsAdequate dairy (> 3 standard daily servings) | Dietary supplement | 2 |
| Dairy Foods< 1 standard dairy serving/day | Dietary supplement | 1 |
Primary outcome
Body weight change
Time frame: 6 months
Body Fat Change
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2008.
- Derived from this study: PubMed 19889829Zemel 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.
- Derived from this study: PubMed 18950508Zemel 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael B Zemel, PhD principal investigator
University of Tennessee
Joseph E Donnelly, PhD principal investigator
University of Kansas
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dairy Foods in people with Obesity and Weight Gain, run by University of Tennessee at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 May 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Body weight change (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00686426, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 May 2008.