ObesityNCT00428987
Physical and Behavioral Traits of Overweight and Obese Adults
An observational study of Obesity and Healthy Volunteers, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) at 1 site in United States.
Trial summary
This study will describe the phenotype (physical and behavioral traits) of overweight and obese people. It will characterize the hormones, metabolism, food preferences, fitness and physical activity levels, sleep patterns and thought processes in people with and without weight problems. Read more about this study
- Who is it for?
- Ages 18 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity, Healthy Volunteers
- How many people
- 2,000 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Mar 2007to not given
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 18 to 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: men and women 18 years old and over with BMI > 30 BMI > 25 and < 30 BMI > 18.5 and < 25
Who may be able to join
- Obese subjects:
- Obese men and women over the age of 18 years
- BMI > 30
- Overweight subjects:
- Overweight men and women over the age of 18 years
- BMI > 25 and < 30
Show all 9Show fewer
- Control subjects (may be matched for age, sex and years of education):
- Normal weight men and women over the age of 18 years
- BMI > 18.5 and < 25
Who cannot join
- Patients with significant physical limitations that may preclude them from completing the majority of the tests in this study
- Current unstable medical conditions including cardiac ischemia, severe respiratory insufficiency requiring oxygen therapy, hepatic or cardiac failure as assessed by history and physical exam
- Any psychiatric condition that would preclude participation in the study
- Patients unwilling or unable to give informed consent
- Pregnant woman.
- Additional exclusion for lean control subjects:
Show all 9Show fewer
- Previous history of obesity as an adolescent or adult
- Current or past history of eating disorders such as anorexia nervosa or bulimia
- The NIH Patient Recruitment and Public Liaison Office will receive inquiries from interested study subjects. Pre-screening by this office will exclude patients who require more than minimal assistance to complete activities of daily living in order to select subjects who can safely participate in the full phenotyping protocol. All others will be contacted by the protocol team to review exclusion criteria. Eligible patients will be invited to Clinical Research Center for a screening visit.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR), 800-411-1222 ext. TTY dial 711, ccopr@nih.gov
About this study
Official title: Study of the Phenotype of Overweight and Obese Adults
This study will describe the phenotype (physical and behavioral traits) of overweight and obese people. It will characterize the hormones, metabolism, food preferences, fitness and physical activity levels, sleep patterns and thought processes in people with and without weight problems. Genetic material will be collected for studies of the internal codes that influence body weight.
People over 18 years of age from all weight categories (lean, overweight, obese) who are reasonably healthy may be eligible for this study. Participants undergo the following tests and procedures:
- Physical exam, electrocardiogram, blood and urine tests, instructions for recording food intake for 7 days
- Metabolic studies for menstruating women.
- Resting metabolic rate to study how many calories the body burns at rest.
- Mixed meal test to measure hormones such as insulin that regulate blood sugar.
- Glucose tolerance test to determine how sensitive the body is to insulin.
- 24-hour energy expenditure to measure the amount of oxygen breathed in and the amount of carbon dioxide breathed out.
- Repeat 24-hour energy expenditure.
- Diurnal blood sampling and temperature assessment to study the body s internal clock.
- Air-displacement plethysmography (Bod Pod) to measure body composition.
- Dual energy x-ray absortiometry (DEXA) to measure body fat and bone density.
- Repeat Bod Pod and DEXA.
- Anthropometric measurements and bioelectrical impedance to measure height, weight, and circumferences, skinfold thickness, fluid status and percentage body fat.
- Bromide dilution to measure the amount of water not in cells in the body.
- Doubly labeled water to measure the amount of calories burned in a 7-day period.
- 24-hour diet reports.
- Endothelial reactivity to measure how the blood vessels stretch or dilate for assessing cardiovascular health.
- Treadmill or bicycle exercise capacity test.
- Physical activity monitor.
- Unicorder to detect any breathing difficulties that may interfere with sleep.
- Fat and muscle biopsy to look for variations in gene expression in fat tissue and muscle.
- Neurocognitive testing to check memory, decision-making, hand-eye coordination, and reasoning.
- Evaluation of mood problems and assess personality type.
- Evaluation to assess the quantity and quality of pain experienced.
- Taste testing to determine the response to bitter, salty, sweet and sour substances.
- Occupational therapy evaluation to explore the subject's adaptations, if any, for performing personal, social or professional activities; the subject's views on his or her weight, body size and shape, and strategies to control weight.
Read the detailed description
Although complex metabolic, hormonal, and neural networks operate to control body weight, obesity is in most cases, the result of over-feeding and inactivity. In most obese patients, patterns of fundamental behavior determine the success or failure of weight loss interventions. Behavior is controlled to some degree by conscious decision making and is influenced by signals from the integrated networks involved in body weight regulation. The contributions of behavior, environment, socioeconomic status, physiology and genetics assure that no single therapeutic regimen will be successful in all obese individuals. In order to explore the factors that impede weight loss and result in weight regain, the obese phenotype and its variants must be defined. The purpose of this study is to detail hormonal, metabolic, cognitive and behavioral traits across the spectrum of weight categories utilizing the state-of the-art facilities of the Metabolic Units at the Mark O. Hatfield Clinical Research Center, NIH. Genetic material will be banked for analysis of phenotypic subgroups as they emerge.
Patients over the age of 18 are eligible for this study. While childhood obesity is an important public health issue, the variables of growth and hormonal controls will be delineated in separate studies. Over-weight and obese patients are encouraged to participate in as full an evaluation as feasible. Lean individuals will be recruited to create a normative database for body composition (dual energy x-ray absortiometry, air displacement plethysmography), energy expenditure (resting energy expenditure, 24h respiratory chamber and doubly labeled water) and other techniques used to study traits of importance. The study will be conducted in both the inpatient and outpatient setting and can include evaluation of hormones, diurnal variation, sleep, eating behavior and taste perception, physical fitness, psychological and neurocognitive functioning. Importantly, this protocol is the means by which pilot data are obtained to develop novel approaches and hypotheses for studying obesity and its associated traits.
- Conditions
- Obesity, Healthy Volunteers
- Keywords
- Energy Expenditure, Body Composition, Obesity, Metabolism, Phenotype, Natural History, Morbid Obesity, Overweight, Healthy Volunteer
- Medical subject headings
- Obesity, Obesity, Morbid, Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| lean | Normal weight men and women over the age of 18 years with BMI greater than 18.5 and less than 25, who are reasonably healthy | |
| obese | Obese men and women over the age of 18 years with BMI greater than 30, who are reasonably healthy | |
| overweight | Overweight men and women over the age of 18 years with BMI greater than 25 and less than 30, who are reasonably healthy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Phenotype (physical and behavioral traits) of overweight and obese people
The aim of this study is to extensively phenotype subjects with varying degrees of obesity, as well as those with rare adipose disorders such as multiple symmetric lipomatosis (Madelung s disease), Dercums disease (adiposis dolorosa) and lipedema; to assess their hormonal, metabolic, cognitive and behavioral traits.
Measured: Two weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2007 (estimated)
- Study start8 Mar 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)The sponsor's other registered studies.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 2,000 participants (estimated)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Ranganath Muniyappa, M.D., Principal investigator, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00428987
- Sponsor's protocol ID
- 070077
- Other IDs
- 07-DK-0077
- Status last verified
- 26 Aug 2026
- First submitted
- 27 Jan 2007
- Last updated
- 28 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Adams KF, Schatzkin A, Harris TB, Kipnis V, Mouw T, Ballard-Barbash R, Hollenbeck A, Leitzmann MF. Overweight, obesity, and mortality in a large prospective cohort of persons 50 to 71 years old. N Engl J Med. 2006 Aug 24;355(8):763-78. doi: 10.1056/NEJMoa055643. Epub 2006 Aug 22.
PubMed 16926275Calle EE, Rodriguez C, Walker-Thurmond K, Thun MJ. Overweight, obesity, and mortality from cancer in a prospectively studied cohort of U.S. adults. N Engl J Med. 2003 Apr 24;348(17):1625-38. doi: 10.1056/NEJMoa021423.
PubMed 12711737Fontaine KR, Redden DT, Wang C, Westfall AO, Allison DB. Years of life lost due to obesity. JAMA. 2003 Jan 8;289(2):187-93. doi: 10.1001/jama.289.2.187.
PubMed 12517229Meral R, Malandrino N, Walter M, Neidert AH, Muniyappa R, Oral EA, Brown RJ. Endogenous Leptin Concentrations Poorly Predict Metreleptin Response in Patients With Partial Lipodystrophy. J Clin Endocrinol Metab. 2022 Mar 24;107(4):e1739-e1751. doi: 10.1210/clinem/dgab760.
PubMed 34677608Armiyaw L, Sarcone C, Fosam A, Muniyappa R. Increased beta-Cell Responsivity Independent of Insulin Sensitivity in Healthy African American Adults. J Clin Endocrinol Metab. 2020 Jul 1;105(7):e2429-38. doi: 10.1210/clinem/dgaa234.
PubMed 32382759Fosam A, Sikder S, Abel BS, Tella SH, Walter MF, Mari A, Muniyappa R. Reduced Insulin Clearance and Insulin-Degrading Enzyme Activity Contribute to Hyperinsulinemia in African Americans. J Clin Endocrinol Metab. 2020 Apr 1;105(4):e1835-46. doi: 10.1210/clinem/dgaa070.
PubMed 32052016Kassai A, Muniyappa R, Levenson AE, Walter MF, Abel BS, Ring M, Taylor SI, Biddinger SB, Skarulis MC, Gorden P, Brown RJ. Effect of Leptin Administration on Circulating Apolipoprotein CIII levels in Patients With Lipodystrophy. J Clin Endocrinol Metab. 2016 Apr;101(4):1790-7. doi: 10.1210/jc.2015-3891. Epub 2016 Feb 22.
PubMed 26900642Muniyappa R, Noureldin R, Ouwerkerk R, Liu EY, Madan R, Abel BS, Mullins K, Walter MF, Skarulis MC, Gharib AM. Myocardial Fat Accumulation Is Independent of Measures of Insulin Sensitivity. J Clin Endocrinol Metab. 2015 Aug;100(8):3060-8. doi: 10.1210/jc.2015-1139. Epub 2015 May 28.
PubMed 26020762Muniyappa R, Sable S, Ouwerkerk R, Mari A, Gharib AM, Walter M, Courville A, Hall G, Chen KY, Volkow ND, Kunos G, Huestis MA, Skarulis MC. Metabolic effects of chronic cannabis smoking. Diabetes Care. 2013 Aug;36(8):2415-22. doi: 10.2337/dc12-2303. Epub 2013 Mar 25.
PubMed 23530011Heikens MJ, Gorbach AM, Eden HS, Savastano DM, Chen KY, Skarulis MC, Yanovski JA. Core body temperature in obesity. Am J Clin Nutr. 2011 May;93(5):963-7. doi: 10.3945/ajcn.110.006270. Epub 2011 Mar 2.
PubMed 21367952
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Phenotype of Overweight and Obese Adults
- ClinicalTrials.gov ID
- NCT00428987
- Acronym / sponsor ID
- 070077
- Conditions
- Obesity, Healthy Volunteers
- Keywords
- Energy Expenditure, Body Composition, Obesity, Metabolism, Phenotype, Natural History, Morbid Obesity, Overweight
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)US National Institutes of Health
- Study start
- 8 Mar 2007 (actual)
- First posted
- 30 Jan 2007 (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.
This study will describe the phenotype (physical and behavioral traits) of overweight and obese people. It will characterize the hormones, metabolism, food preferences, fitness and physical activity levels, sleep patterns and thought processes in people with and without weight problems. Genetic material will be collected for studies of the internal codes that influence body weight.
People over 18 years of age from all weight categories (lean, overweight, obese) who are reasonably healthy may be eligible for this study. Participants undergo the following tests and procedures:
- Physical exam, electrocardiogram, blood and urine tests, instructions for recording food intake for 7 days
- Metabolic studies for menstruating women.
- Resting metabolic rate to study how many calories the body burns at rest.
- Mixed meal test to measure hormones such as insulin that regulate blood sugar.
- Glucose tolerance test to determine how sensitive the body is to insulin.
- 24-hour energy expenditure to measure the amount of oxygen breathed in and the amount of carbon dioxide breathed out.
- Repeat 24-hour energy expenditure.
- Diurnal blood sampling and temperature assessment to study the body s internal clock.
- Air-displacement plethysmography (Bod Pod) to measure body composition.
- Dual energy x-ray absortiometry (DEXA) to measure body fat and bone density.
- Repeat Bod Pod and DEXA.
- Anthropometric measurements and bioelectrical impedance to measure height, weight, and circumferences, skinfold thickness, fluid status and percentage body fat.
- Bromide dilution to measure the amount of water not in cells in the body.
- Doubly labeled water to measure the amount of calories burned in a 7-day period.
- 24-hour diet reports.
- Endothelial reactivity to measure how the blood vessels stretch or dilate for assessing cardiovascular health.
- Treadmill or bicycle exercise capacity test.
- Physical activity monitor.
- Unicorder to detect any breathing difficulties that may interfere with sleep.
- Fat and muscle biopsy to look for variations in gene expression in fat tissue and muscle.
- Neurocognitive testing to check memory, decision-making, hand-eye coordination, and reasoning.
- Evaluation of mood problems and assess personality type.
- Evaluation to assess the quantity and quality of pain experienced.
- Taste testing to determine the response to bitter, salty, sweet and sour substances.
- Occupational therapy evaluation to explore the subject's adaptations, if any, for performing personal, social or professional activities; the subject's views on his or her weight, body size and shape, and strategies to control weight.
Detailed description
Although complex metabolic, hormonal, and neural networks operate to control body weight, obesity is in most cases, the result of over-feeding and inactivity. In most obese patients, patterns of fundamental behavior determine the success or failure of weight loss interventions. Behavior is controlled to some degree by conscious decision making and is influenced by signals from the integrated networks involved in body weight regulation. The contributions of behavior, environment, socioeconomic status, physiology and genetics assure that no single therapeutic regimen will be successful in all obese individuals. In order to explore the factors that impede weight loss and result in weight regain, the obese phenotype and its variants must be defined. The purpose of this study is to detail hormonal, metabolic, cognitive and behavioral traits across the spectrum of weight categories utilizing the state-of the-art facilities of the Metabolic Units at the Mark O. Hatfield Clinical Research Center, NIH. Genetic material will be banked for analysis of phenotypic subgroups as they emerge.
Patients over the age of 18 are eligible for this study. While childhood obesity is an important public health issue, the variables of growth and hormonal controls will be delineated in separate studies. Over-weight and obese patients are encouraged to participate in as full an evaluation as feasible. Lean individuals will be recruited to create a normative database for body composition (dual energy x-ray absortiometry, air displacement plethysmography), energy expenditure (resting energy expenditure, 24h respiratory chamber and doubly labeled water) and other techniques used to study traits of importance. The study will be conducted in both the inpatient and outpatient setting and can include evaluation of hormones, diurnal variation, sleep, eating behavior and taste perception, physical fitness, psychological and neurocognitive functioning. Importantly, this protocol is the means by which pilot data are obtained to develop novel approaches and hypotheses for studying obesity and its associated traits.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| lean | – | –Normal weight men and women over the age of 18 years with BMI greater than 18.5 and less than 25, who are reasonably healthy |
| obese | – | –Obese men and women over the age of 18 years with BMI greater than 30, who are reasonably healthy |
| overweight | – | –Overweight men and women over the age of 18 years with BMI greater than 25 and less than 30, who are reasonably healthy |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- men and women 18 years old and over with BMI > 30 BMI > 25 and < 30 BMI > 18.5 and < 25
Key inclusion criteria (9 listed)
- Obese men and women over the age of 18 years
- BMI > 30
- Overweight men and women over the age of 18 years
- BMI > 25 and < 30
- Normal weight men and women over the age of 18 years
Key exclusion criteria (9 listed)
- Patients with significant physical limitations that may preclude them from completing the majority of the tests in this study
- Current unstable medical conditions including cardiac ischemia, severe respiratory insufficiency requiring oxygen therapy, hepatic or cardiac failure as assessed by history and physical exam
- Any psychiatric condition that would preclude participation in the study
- Patients unwilling or unable to give informed consent
- Pregnant woman.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Phenotype (physical and behavioral traits) of overweight and obese people
Time frame: Two weeks
The aim of this study is to extensively phenotype subjects with varying degrees of obesity, as well as those with rare adipose disorders such as multiple symmetric lipomatosis (Madelung s disease), Dercums disease (adiposis dolorosa) and lipedema; to assess their hormonal, metabolic, cognitive and behavioral traits.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2026.
- Background: PubMed 16926275Adams KF, Schatzkin A, Harris TB, Kipnis V, Mouw T, Ballard-Barbash R, Hollenbeck A, Leitzmann MF. Overweight, obesity, and mortality in a large prospective cohort of persons 50 to 71 years old. N Engl J Med. 2006 Aug 24;355(8):763-78. doi: 10.1056/NEJMoa055643. Epub 2006 Aug 22.
- Background: PubMed 12711737Calle EE, Rodriguez C, Walker-Thurmond K, Thun MJ. Overweight, obesity, and mortality from cancer in a prospectively studied cohort of U.S. adults. N Engl J Med. 2003 Apr 24;348(17):1625-38. doi: 10.1056/NEJMoa021423.
- Background: PubMed 12517229Fontaine KR, Redden DT, Wang C, Westfall AO, Allison DB. Years of life lost due to obesity. JAMA. 2003 Jan 8;289(2):187-93. doi: 10.1001/jama.289.2.187.
- Derived from this study: PubMed 34677608Meral R, Malandrino N, Walter M, Neidert AH, Muniyappa R, Oral EA, Brown RJ. Endogenous Leptin Concentrations Poorly Predict Metreleptin Response in Patients With Partial Lipodystrophy. J Clin Endocrinol Metab. 2022 Mar 24;107(4):e1739-e1751. doi: 10.1210/clinem/dgab760.
- Derived from this study: PubMed 32382759Armiyaw L, Sarcone C, Fosam A, Muniyappa R. Increased beta-Cell Responsivity Independent of Insulin Sensitivity in Healthy African American Adults. J Clin Endocrinol Metab. 2020 Jul 1;105(7):e2429-38. doi: 10.1210/clinem/dgaa234.
- Derived from this study: PubMed 32052016Fosam A, Sikder S, Abel BS, Tella SH, Walter MF, Mari A, Muniyappa R. Reduced Insulin Clearance and Insulin-Degrading Enzyme Activity Contribute to Hyperinsulinemia in African Americans. J Clin Endocrinol Metab. 2020 Apr 1;105(4):e1835-46. doi: 10.1210/clinem/dgaa070.
- Derived from this study: PubMed 26900642Kassai A, Muniyappa R, Levenson AE, Walter MF, Abel BS, Ring M, Taylor SI, Biddinger SB, Skarulis MC, Gorden P, Brown RJ. Effect of Leptin Administration on Circulating Apolipoprotein CIII levels in Patients With Lipodystrophy. J Clin Endocrinol Metab. 2016 Apr;101(4):1790-7. doi: 10.1210/jc.2015-3891. Epub 2016 Feb 22.
- Derived from this study: PubMed 26020762Muniyappa R, Noureldin R, Ouwerkerk R, Liu EY, Madan R, Abel BS, Mullins K, Walter MF, Skarulis MC, Gharib AM. Myocardial Fat Accumulation Is Independent of Measures of Insulin Sensitivity. J Clin Endocrinol Metab. 2015 Aug;100(8):3060-8. doi: 10.1210/jc.2015-1139. Epub 2015 May 28.
- Derived from this study: PubMed 23530011Muniyappa R, Sable S, Ouwerkerk R, Mari A, Gharib AM, Walter M, Courville A, Hall G, Chen KY, Volkow ND, Kunos G, Huestis MA, Skarulis MC. Metabolic effects of chronic cannabis smoking. Diabetes Care. 2013 Aug;36(8):2415-22. doi: 10.2337/dc12-2303. Epub 2013 Mar 25.
- Derived from this study: PubMed 21367952Heikens MJ, Gorbach AM, Eden HS, Savastano DM, Chen KY, Skarulis MC, Yanovski JA. Core body temperature in obesity. Am J Clin Nutr. 2011 May;93(5):963-7. doi: 10.3945/ajcn.110.006270. Epub 2011 Mar 2.
- NIH Clinical Center Detailed Web PageLink provided by the sponsor.
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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.
Ranganath Muniyappa, M.D. principal investigator
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obesity and Healthy Volunteers, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) at 1 site 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 9 inclusion and 9 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: looking for participants now, as of the sponsor's last update on 28 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Antoinette C Rabel, C.R.N.P. ((301) 451-8893, rabela@mail.nih.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Phenotype (physical and behavioral traits) of overweight and obese people (time frame: Two weeks). 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 NCT00428987, which also lists 10 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 28 Sep 2026.