ObesityNCT01146704
Gastrointestinal Hormonal Regulation of Obesity
A study testing Protein powder supplement, standard dosage based on 0.5 gram protein per pound of subject's lean body mass and Protein powder supplement, High Level Protein, based on 1 gram of protein per pound of lean body mass: 25% protein and 45% carbohydrate in people with Obesity, run by VA Office of Research and Development at 1 site in United States.
Trial summary
The objective of this study is to test and determine whether a high protein diet is efficacious, safe and beneficial to curtail food intake and body weight in obese adult human patients and to establish whether neurohormonal mechanisms of a high protein diet induce an early signal of fullness or satiety in a relevant… Read more about this study
- Who is it for?
- Ages 30 years and olderHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- Protein powder supplement, standard dosage based on 0.5 gram protein per pound of subject's lean body mass and Protein powder supplement, High Level Protein, based on 1 gram of protein per pound of lean body mass: 25% protein and 45% carbohydrate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2010to 27 Feb 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 30 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- For inclusion in the study, patients must fulfill all of the following criteria:
- Subjects must be able to attend all 7 scheduled study visits at the West LA GI clinic at the VAGLAHS, not including the screening visit.
- Subjects must sign the VA Greater Los Angeles Healthcare System Institutional Review Board approved written informed consent prior to the initiation of any study-related activities or study specific procedures or randomization.
- Subjects must have given written authorization for the release of protected health information in compliance with Health Insurance Portability and Accountability Act (HIPAA) regulations.
- After the Informed Consent process, these additional Inclusion Criteria will be applied to potential subjects:
- Age 30 years and older at screening.
Show all 11Show fewer
- BMI of 27 to 40 kg/m2 inclusive.
- Subjects must be in good health as determined by medical history, physical examination performed by the Investigator (Study doctor) at the Screening stage, and screening clinical laboratory tests including chemistry panel and CBC.
- Must have stable smoking habits (or be non-smokers) for at least 6 months prior to screening and agree not to intend to change such habits during the course of the study.
- Subjects requiring the regular use of any prescription medication may be admitted to the study, providing the dose is stable.
- Subjects must be able to communicate and cooperate with the Principal Investigator and the staff and willing to comply with the study instructions.
Who cannot join
- Weight instability: Subjects reporting weight change of greater than 3.0 kg in the month prior to screening.
- Any subject who has been on a very low calorie diet (less than 800 kcal/day) for a period of 4 months or more in the 12 months prior to screening, or who has lost greater than 10 kg in the 6 months prior to screening.
- Any subject who has a history of diabetic gastroparesis or gastric emptying disorder as indicated in the potential subject's medical history and VA's Computer Patient Record System (CPRS).
- Use of any other investigational drug(s) within 8 weeks prior to screening.
- Subjects should not have received antibiotics within the prior 4 weeks of screening.
- Abnormal laboratory parameters:
Show all 14Show fewer
- Serum creatinine greater than 1.6 mg/dL;
- Liver function tests, alanine transaminase (ALT), alanine transaminase (AST), Bilirubin results greater than 2.0 times the upper limit of normal;
- Triglycerides greater than 500 mg/dL;
- Total cholesterol greater than 350 mg/dL;
- Thyroid-stimulating hormone (TSH) outside of normal range disorder, as indicated in the potential subject's medical history, the VA's Computer Patient Record System (CPRS) and laboratory tests performed during the screening process.
- Subjects who drink more than 1 alcoholic beverage per day (that is: 1 beer; or 1 glass of wine; or 1 shot of liquor).
- Pregnant women or women likely to become pregnant during the course of the study may not participate in this study. Female subjects must not be able to conceive by reason of surgery, radiation, one year past the onset of menopause, or an approved method of contraception.
- No vulnerable subjects will be included in the study.
Trial locations and contacts
1 site in 1 country.
United States1 site
VA Greater Los Angeles Healthcare System, West Los Angeles, CA
West Los Angeles, California, 90073
About this study
The objective of this study is to test and determine whether a high protein diet is efficacious, safe and beneficial to curtail food intake and body weight in obese adult human patients and to establish whether neurohormonal mechanisms of a high protein diet induce an early signal of fullness or satiety in a relevant experimental model, focusing on activation of gastric vagal afferents.
Read the detailed description
Obesity is a major cause of morbidity and mortality within the VA medical system accounting for the majority of cases of diabetes mellitus, hypertension, coronary artery disease and cerebrovascular accidents. An improved understanding of the regulation of body weight in Veteran obese patients will improve the quality of life by avoidance of serious medical complications and by suggesting novel therapeutic approaches.
The large proportion of the Veteran population that frequent the VA health care system and who suffer from obesity or have obesity-related illnesses can benefit from this research.
Obesity is associated with early mortality in the United States. It has been estimated to result in about 280,000 deaths per year in U.S. adults and the expenses related to obesity are in excess of $80 billion. Obesity is a major cause of morbidity and mortality within the VA medical system accounting for the majority of cases of diabetes mellitus, hypertension, coronary artery disease and cerebrovascular accidents.
The proposed studies will address important physiological questions regarding the mechanisms of gut peptides regulating satiety and food intake, as well as provide potentially important clinical treatment strategies. The release of GI hormones in response to meal stimuli plays an important role in the regulation of body weight homeostasis. The neural pathways interconnecting gut signaling of satiety to the brain in response to nutrient intake are regulated by neuropeptides and GI hormones.
The investigators have a long history in the study of GI hormones. In the current application, the investigators plan to elucidate the impact of a high protein diet on the profile of gut hormones released postprandially in obese subjects and the underlying changes at the neuronal (vagal afferent) level that take place in response to a high protein diet in a relevant experimental model.
Understanding the regulatory mechanisms involved in satiety will provide clues for existing and novel forms of therapies. Studies may also provide insight into underlying mechanisms responsible for weight loss induced by gastroplasty and bariatric procedure used for the treatment of obesity.
The study design is a three-group randomized, controlled study. This randomized controlled study lasting 24-30 months will assign approximately 198 volunteer subjects (ages 30, BMI 27-40 kg/m2) (66 subjects each) to the following three groups who will adhere to diets with the same number of calories:
- Very high protein diet group based on 1.4 gram of protein per pound of lean body mass,
- High protein diet group based on 1 gram of protein per pound of lean body mass, and
- Standard protein diet group as control based on 0.5 gram protein per pound of lean body mass with same calories.
All participants will meet with a Registered Dietitian (who it is anticipated will join the research study team), to assist them with their diet efforts in all the arms.
In the study, the percent energy from fat will be held constant at 30% and the differences in the diets relate only to the protein and carbohydrate contents (35% protein and 35% carbohydrate, 25% protein and 45% carbohydrate, and 12.5% protein and 57.5% carbohydrate respectively).
The investigators will assess the efficacy of a high protein diet on satiety and pattern of postprandial gut hormone in obese patients. All the subjects will be followed by a dietitian and determination of circulating gut hormone and biochemical assays will be performed.
- Conditions
- Obesity
- Being tested
- Protein powder supplement, standard dosage based on 0.5 gram protein per pound of subject's lean body mass, Protein powder supplement, High Level Protein, based on 1 gram of protein per pound of lean body mass: 25% protein and 45% carbohydrate
- Keywords
- Obesity
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Protein powder supplement, standard dosage based on 0.5 gram protein per pound of subject's lean body massDietary supplement
Also called Standard Protein Diet
Standard protein diet as control, based on 0.5 gram protein per pound of lean body mass, isocaloric (same number of calories) and consisting of 15% protein and 55% carbohydrate.
Protein powder supplement, High Level Protein, based on 1 gram of protein per pound of lean body mass: 25% protein and 45% carbohydrateDietary supplement
Also called High Protein Diet
High level of protein diet, based on 1 gram of protein per pound of subject's lean body mass, isocaloric (same number of calories) and consisting of 30% protein and 40% carbohydrate.
| Study group | Role | What they receive |
|---|---|---|
| Standard Diet | Active comparator | Standard protein diet group as control based on 0.5 gram protein per pound of lean body mass with same calories: 15% protein and 55% carbohydrate. Receives: Dietary Supplement: Protein powder supplement, standard dosage based on 0.5 gram protein per pound of subject's lean body mass |
| High Protein Diet | Active comparator | High protein diet group based on 1 gram of protein per pound of lean body mass: 30% protein and 40% carbohydrate. Receives: Dietary Supplement: Protein powder supplement, High Level Protein, based on 1 gram of protein per pound of lean body mass: 25% protein and 45% carbohydrate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Body Weight From Baseline to 12 Months
The primary objective is to compare weight loss between each of the two diets, a high-protein diet versus a standard diet.
Measured: The primary outcome of weight loss is measured at the Baseline at Day 1, and at the end of the 12 months study period for each subject.
Secondary outcomes (3)
Efficacy Variables: Nutrition Assessments (FFQ, 3DFR, and Satiety Questionnaire), Anthropometric Profiles (e.g., Waist and Hip Circumferences), Lab and Biochemical Variables (e.g., Insulin, Lipid Levels, HbA1c), Body Composition (Body Fat), Hormone Level
High-protein diet promotes sensitivity to cholecystokinin and shifts the cecal microbiome without altering brain inflammation in diet-induced obesity
Measured: The outcome of efficacy is measured at Day 1 Baseline and at monthly visits during the 12 month study period for each subject.
Safety Variables: Incidence, Severity and Duration of Adverse Events, Vital Signs, Concomitant Medications and Physical Examination Results.
High-protein diet promotes sensitivity to cholecystokinin and shifts the cecal microbiome without altering brain inflammation in diet-induced obesity
Measured: Safety variables are measured at the time any adverse events occur, and vital signs, concomitant medications and physical examination results are measured at Baseline on Day 1 and monthly throughout the 12 month study period for each subject.
Improvement in NAFLD Fibrosis Score
Patients enrolled with a history of NAFLD will be assessed for improvement in NAFLD Fibrosis scoring index and other imaging parameters if performed as standard clinical care.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2010 (estimated)
- Study start1 Sep 2010
- Primary completion31 Dec 2018
- Study completion27 Feb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Joseph R Pisegna, MD, Principal investigator, VA Greater Los Angeles Healthcare System, West Los Angeles, CA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01146704
- Sponsor's protocol ID
- F7219-R
- Status last verified
- Jan 2025
- First submitted
- 2 Apr 2010
- Last updated
- 4 Feb 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Wang L, Jacobs JP, Lagishetty V, Yuan PQ, Wu SV, Million M, Reeve JR Jr, Pisegna JR, Tache Y. High-protein diet improves sensitivity to cholecystokinin and shifts the cecal microbiome without altering brain inflammation in diet-induced obesity in rats. Am J Physiol Regul Integr Comp Physiol. 2017 Oct 1;313(4):R473-R486. doi: 10.1152/ajpregu.00105.2017. Epub 2017 Jul 19.
PubMed 28724546Vu JP, Luong L, Parsons WF, Oh S, Sanford D, Gabalski A, Lighton JR, Pisegna JR, Germano PM. Long-Term Intake of a High-Protein Diet Affects Body Phenotype, Metabolism, and Plasma Hormones in Mice. J Nutr. 2017 Dec;147(12):2243-2251. doi: 10.3945/jn.117.257873. Epub 2017 Oct 25.
PubMed 29070713Stengel A, Goebel-Stengel M, Wang L, Hu E, Karasawa H, Pisegna JR, Tache Y. High-protein diet selectively reduces fat mass and improves glucose tolerance in Western-type diet-induced obese rats. Am J Physiol Regul Integr Comp Physiol. 2013 Sep 15;305(6):R582-91. doi: 10.1152/ajpregu.00598.2012. Epub 2013 Jul 24.
PubMed 23883680Vu JP, Goyal D, Luong L, Oh S, Sandhu R, Norris J, Parsons W, Pisegna JR, Germano PM. PACAP intraperitoneal treatment suppresses appetite and food intake via PAC1 receptor in mice by inhibiting ghrelin and increasing GLP-1 and leptin. Am J Physiol Gastrointest Liver Physiol. 2015 Nov 15;309(10):G816-25. doi: 10.1152/ajpgi.00190.2015. Epub 2015 Sep 3.
PubMed 26336928
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gastrointestinal Hormonal Regulation of Obesity
- ClinicalTrials.gov ID
- NCT01146704
- Acronym / sponsor ID
- F7219-R
- Conditions
- Obesity
- Keywords
- Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 1 Sep 2010 (actual)
- Primary completion
- 31 Dec 2018 (actual)
- Study completion
- 27 Feb 2019 (actual)
- First posted
- 17 Jun 2010 (estimated)
- Results
- Posted 10 Feb 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this study is to test and determine whether a high protein diet is efficacious, safe and beneficial to curtail food intake and body weight in obese adult human patients and to establish whether neurohormonal mechanisms of a high protein diet induce an early signal of fullness or satiety in a relevant experimental model, focusing on activation of gastric vagal afferents.
Detailed description
Obesity is a major cause of morbidity and mortality within the VA medical system accounting for the majority of cases of diabetes mellitus, hypertension, coronary artery disease and cerebrovascular accidents. An improved understanding of the regulation of body weight in Veteran obese patients will improve the quality of life by avoidance of serious medical complications and by suggesting novel therapeutic approaches.
The large proportion of the Veteran population that frequent the VA health care system and who suffer from obesity or have obesity-related illnesses can benefit from this research.
Obesity is associated with early mortality in the United States. It has been estimated to result in about 280,000 deaths per year in U.S. adults and the expenses related to obesity are in excess of $80 billion. Obesity is a major cause of morbidity and mortality within the VA medical system accounting for the majority of cases of diabetes mellitus, hypertension, coronary artery disease and cerebrovascular accidents.
The proposed studies will address important physiological questions regarding the mechanisms of gut peptides regulating satiety and food intake, as well as provide potentially important clinical treatment strategies. The release of GI hormones in response to meal stimuli plays an important role in the regulation of body weight homeostasis. The neural pathways interconnecting gut signaling of satiety to the brain in response to nutrient intake are regulated by neuropeptides and GI hormones.
The investigators have a long history in the study of GI hormones. In the current application, the investigators plan to elucidate the impact of a high protein diet on the profile of gut hormones released postprandially in obese subjects and the underlying changes at the neuronal (vagal afferent) level that take place in response to a high protein diet in a relevant experimental model.
Understanding the regulatory mechanisms involved in satiety will provide clues for existing and novel forms of therapies. Studies may also provide insight into underlying mechanisms responsible for weight loss induced by gastroplasty and bariatric procedure used for the treatment of obesity.
The study design is a three-group randomized, controlled study. This randomized controlled study lasting 24-30 months will assign approximately 198 volunteer subjects (ages 30, BMI 27-40 kg/m2) (66 subjects each) to the following three groups who will adhere to diets with the same number of calories:
- Very high protein diet group based on 1.4 gram of protein per pound of lean body mass,
- High protein diet group based on 1 gram of protein per pound of lean body mass, and
- Standard protein diet group as control based on 0.5 gram protein per pound of lean body mass with same calories.
All participants will meet with a Registered Dietitian (who it is anticipated will join the research study team), to assist them with their diet efforts in all the arms.
In the study, the percent energy from fat will be held constant at 30% and the differences in the diets relate only to the protein and carbohydrate contents (35% protein and 35% carbohydrate, 25% protein and 45% carbohydrate, and 12.5% protein and 57.5% carbohydrate respectively).
The investigators will assess the efficacy of a high protein diet on satiety and pattern of postprandial gut hormone in obese patients. All the subjects will be followed by a dietitian and determination of circulating gut hormone and biochemical assays will be performed.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard Diet | Active comparator | Dietary Supplement: Protein powder supplement, standard dosage based on 0.5 gram protein per pound of subject's lean body massStandard protein diet group as control based on 0.5 gram protein per pound of lean body mass with same calories: 15% protein and 55% carbohydrate. |
| High Protein Diet | Active comparator | Dietary Supplement: Protein powder supplement, High Level Protein, based on 1 gram of protein per pound of lean body mass: 25% protein and 45% carbohydrateHigh protein diet group based on 1 gram of protein per pound of lean body mass: 30% protein and 40% carbohydrate. |
Who may qualify
- Ages
- 30 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Subjects must be able to attend all 7 scheduled study visits at the West LA GI clinic at the VAGLAHS, not including the screening visit.
- Subjects must sign the VA Greater Los Angeles Healthcare System Institutional Review Board approved written informed consent prior to the initiation of any study-related activities or study specific procedures or randomization.
- Subjects must have given written authorization for the release of protected health information in compliance with Health Insurance Portability and Accountability Act (HIPAA) regulations.
- After the Informed Consent process, these additional Inclusion Criteria will be applied to potential subjects:
- Age 30 years and older at screening.
Key exclusion criteria (14 listed)
- Weight instability: Subjects reporting weight change of greater than 3.0 kg in the month prior to screening.
- Any subject who has been on a very low calorie diet (less than 800 kcal/day) for a period of 4 months or more in the 12 months prior to screening, or who has lost greater than 10 kg in the 6 months prior to screening.
- Any subject who has a history of diabetic gastroparesis or gastric emptying disorder as indicated in the potential subject's medical history and VA's Computer Patient Record System (CPRS).
- Use of any other investigational drug(s) within 8 weeks prior to screening.
- Subjects should not have received antibiotics within the prior 4 weeks of screening.
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 |
|---|---|---|
| Protein powder supplement, standard dosage based on 0.5 gram protein per pound of subject's lean body massAlso: Standard Protein DietStandard protein diet as control, based on 0.5 gram protein per pound of lean body mass, isocaloric (same number of calories) and consisting of 15% protein and 55% carbohydrate. | Dietary supplement | Standard Diet |
| Protein powder supplement, High Level Protein, based on 1 gram of protein per pound of lean body mass: 25% protein and 45% carbohydrateAlso: High Protein DietHigh level of protein diet, based on 1 gram of protein per pound of subject's lean body mass, isocaloric (same number of calories) and consisting of 30% protein and 40% carbohydrate. | Dietary supplement | High Protein Diet |
Primary outcome
Change in Body Weight From Baseline to 12 Months
Time frame: The primary outcome of weight loss is measured at the Baseline at Day 1, and at the end of the 12 months study period for each subject.
The primary objective is to compare weight loss between each of the two diets, a high-protein diet versus a standard diet.
3 secondary outcomes
Efficacy Variables: Nutrition Assessments (FFQ, 3DFR, and Satiety Questionnaire), Anthropometric Profiles (e.g., Waist and Hip Circumferences), Lab and Biochemical Variables (e.g., Insulin, Lipid Levels, HbA1c), Body Composition (Body Fat), Hormone Level
Time frame: The outcome of efficacy is measured at Day 1 Baseline and at monthly visits during the 12 month study period for each subject.
Safety Variables: Incidence, Severity and Duration of Adverse Events, Vital Signs, Concomitant Medications and Physical Examination Results.
Time frame: Safety variables are measured at the time any adverse events occur, and vital signs, concomitant medications and physical examination results are measured at Baseline on Day 1 and monthly throughout the 12 month study period for each subject.
Improvement in NAFLD Fibrosis Score
Time frame: 1 year
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 28724546Wang L, Jacobs JP, Lagishetty V, Yuan PQ, Wu SV, Million M, Reeve JR Jr, Pisegna JR, Tache Y. High-protein diet improves sensitivity to cholecystokinin and shifts the cecal microbiome without altering brain inflammation in diet-induced obesity in rats. Am J Physiol Regul Integr Comp Physiol. 2017 Oct 1;313(4):R473-R486. doi: 10.1152/ajpregu.00105.2017. Epub 2017 Jul 19.
- Background: PubMed 29070713Vu JP, Luong L, Parsons WF, Oh S, Sanford D, Gabalski A, Lighton JR, Pisegna JR, Germano PM. Long-Term Intake of a High-Protein Diet Affects Body Phenotype, Metabolism, and Plasma Hormones in Mice. J Nutr. 2017 Dec;147(12):2243-2251. doi: 10.3945/jn.117.257873. Epub 2017 Oct 25.
- Background: PubMed 23883680Stengel A, Goebel-Stengel M, Wang L, Hu E, Karasawa H, Pisegna JR, Tache Y. High-protein diet selectively reduces fat mass and improves glucose tolerance in Western-type diet-induced obese rats. Am J Physiol Regul Integr Comp Physiol. 2013 Sep 15;305(6):R582-91. doi: 10.1152/ajpregu.00598.2012. Epub 2013 Jul 24.
- Background: PubMed 26336928Vu JP, Goyal D, Luong L, Oh S, Sandhu R, Norris J, Parsons W, Pisegna JR, Germano PM. PACAP intraperitoneal treatment suppresses appetite and food intake via PAC1 receptor in mice by inhibiting ghrelin and increasing GLP-1 and leptin. Am J Physiol Gastrointest Liver Physiol. 2015 Nov 15;309(10):G816-25. doi: 10.1152/ajpgi.00190.2015. Epub 2015 Sep 3.
- Individual participant dataSharing planned: No
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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.
Joseph R Pisegna, MD principal investigator
VA Greater Los Angeles Healthcare System, West Los Angeles, CA
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Protein powder supplement, standard dosage based on 0.5 gram protein per pound of subject's lean body mass and Protein powder supplement, High Level Protein, based on 1 gram of protein per pound of lean body mass: 25% protein and 45% carbohydrate in people with Obesity, run by VA Office of Research and Development 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 11 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 4 Feb 2025. 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?
Yes. Results are posted in the registry (first posted 10 Feb 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Change in Body Weight From Baseline to 12 Months (time frame: The primary outcome of weight loss is measured at the Baseline at Day 1, and at the end of the 12 months study period for each subject.). 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 NCT01146704, which also lists 4 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 4 Feb 2025.