ObesityPhase 1NCT00459992
Effects of Betahistine Hydrochloride in Overweight Women
A Phase 1 study testing Betahistine Hydrochloride in people with Obesity and Overweight, run by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) at 1 site in United States.
Trial summary
This study will evaluate the effects of a drug called betahistine on appetite and food intake in overweight women. Betahistine has been used for many years to treat vertigo (dizziness). Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Obesity, Overweight, Overnutrition
- What is being tested?
- Betahistine Hydrochloride
- How many people
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Apr 2007to 14 Feb 2011
- Phase
- Phase 1
- 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 18 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Volunteers will qualify if they meet the following criteria:
- Good general health. In general, subjects will be required to take no medications. However, individuals taking medications for obesity-related co-morbid conditions, who have not had changes in dosage for more than 6 months, may be included, at the discretion of the principal investigator.
- Age 18-50 years.
- Female sex. In this pilot study, we seek to decrease the variability of subject response to the greatest extent possible. Since women have a higher prevalence of obesity than men, and tend to be the group that most uses weight loss pharmacotherapy, we will only study women in the pilot investigation. Subsequent studies with include both sexes.
- Regular menses (either spontaneous or as a result of oral contraceptive pills) or post-menopausal status (no menses for at least 3 months).
- Obesity, defined as body mass index (BMI) between 30 and 40 kg/m(2) but weight under 300 lbs, in order for subject to be able to undergo DEXA scanning with the Hologic instrument available in the Nuclear Medicine Department.
- A negative pregnancy test at the initial evaluation. Sexually active women must be using an effective form of birth control. These methods include abstinence, oral contraceptives, an intrauterine device (IUD), levonogestrol implants (Norplant), or medroxyprogesterone acetate injections (Depo-provera shots). (One of these methods must have been used by the subject for at least two months prior to the start of the study). If one of these cannot be used, contraceptive foam with a condom is recommended.
- Willingness to participate in the research protocol.
Who cannot join
- Volunteers will be excluded (and referred to non-experimental treatment programs as needed) for the following reasons:
- A presence of major illnesses: renal, hepatic (other than obesity-related steatosis), gastrointestinal, most endocrinologic (e.g., Cushing syndrome, hyper- or hypothyroidism, pheochromocytoma), hematological problems or pulmonary disorders; or porphyria;
- History of anaphylaxis, asthma, urticaria, rhinitis, allergic rash, or other allergic disease requiring antihistamine treatment; subjects with a history of antihistamine treatment for a self-limited allergic reaction such as to poison ivy or to a medication that they are no longer taking may be included at the discretion of the primary investigator.
- History of peptic ulcer disease;
- Baseline QT interval prolongation (greater than or equal to 480 msec QTc) because of reports of histaminergic compounds causing prolonged QT interval and cardiac arrhythmias in susceptible patients (i.e. those with prolonged QT interval at baseline);
- Current smokers of tobacco products;
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- Self-reported lactose intolerance;
- Self-reported food allergy to foods used in standardized food array in this protocol or to betahistine itself;
- Subjects following a diet with specific food requirements such as vegetarian, vegan, or kosher because of the use of a standardized food array in this protocol;
- Subjects with a history of DSMIV classifiable eating disorders such as anorexia nervosa, bulimia nervosa, or binge-eating disorder will be excluded from the current proof-of-concept study;
- Women with reproductive potential who are pregnant or who are currently nursing an infant;
- Individuals who have current substance abuse or a psychiatric disorder or other condition that in the opinion of the investigators would impede competence or compliance or possibly hinder completion of the study;
- Subjects who regularly use prescription medications unrelated to the complications of obesity (especially vasoactive compounds such as calcium channel blockers, nitrates, beta-blockers, etc.), subjects using H2 blockers for dyspepsia, and subjects who require chronic use of antihistamines for allergic conditions; oral contraceptive use will be permitted, provided the contraceptive has been used for at least two months before starting study medication. The use of over-the-counter and prescription medications will be reviewed on a case-by-case basis; depending on the medication, subjects who have continued to take prescription medication for at least 3 months prior to study entry may be eligible. Allowable medications may include statins for the treatment of dyslipidemia and low-dose aspirin for primary prevention of acute coronary syndrome. Medications used for the treatment of hypertension will not be allowed because of the potential vasodilatory activity of betahistine.
- Recent (3 months) use of anorexiant medications;
- Weight change of more than 3% of body weight in the past two months;
- Subjects with a consistently (2 weeks apart) elevated systolic blood pressure of greater than 160 mm Hg and/or a diastolic blood pressure greater than 95 mm Hg.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, 20892
About this study
Official title: Pilot Study of the Metabolic Effects of Betahistine Hydrochloride in Overweight Women
This study will evaluate the effects of a drug called betahistine on appetite and food intake in overweight women. Betahistine has been used for many years to treat vertigo (dizziness). It was taken off the market in the United States in 1970 because it was thought to be ineffective for vertigo, but is still used for this purpose in many other countries. Some research suggests that betahistine may reduce appetite and food intake.
Healthy overweight women between 18 and 50 years of age may be eligible for this study. Candidates must have a body mass index (BMI) between 30 and 40 and weigh less than 300 pounds. They are screened with a medical history and physical examination, blood and urine tests, electrocardiogram (EKG), breathing test and eating behavior questionnaires.
Read more
Participants are admitted to the NIH Clinical Center for a 3-day/2-night stay for the following procedures:
- Medication: Subjects take either betahistine (in one of three possible doses) or placebo capsules one time on the days of admission to the Clinical Center (day 1), three times on day 2 and two times on day 3.
- Blood tests and 24-hour urine collection.
- Resting metabolic rate: Subjects rest quietly for 1 hour after awakening and then rest again under a clear plastic hood or while wearing a face mask, breathing normally for about 25 minutes.
- DEXA scan to measure body fat, muscle, and bone mineral content: Subjects lie on a table above a source of X-rays while a very small dose of X-rays is passed through the body.
- Meal studies: Subjects food intake is measured on days 2 and 3.
- Questionnaires: Subjects complete questionnaires about how hungry or full they are feeling and rate how much they liked the foods they ate.
Read the detailed description
Current medications for the long-term treatment of obesity are moderately effective at best. Therefore, research focusing on compounds that affect energy balance through novel mechanisms is warranted. Preliminary human and animal data suggest central nervous system histaminergic tone is important in the regulation of food intake. We therefore propose to study the effects of betahistine hydrochloride, a histamine analogue which has agonist activity at the histaminergic H1 receptor and antagonist/reverse agonist activity at the H3 receptor. Prior animal studies have suggested that betahistine suppresses food intake and reduces body weight, but there are sparse human data assessing the effects of betahistine on metabolism.
Betahistine s effects on women s food intake and metabolism will be evaluated through an inpatient randomized double-blind placebo controlled dose-ranging study. We will examine the acute effects of betahistine on food intake, hunger, and satiety, resting energy expenditure, and on hormones and substrates relevant for body weight regulation. If results suggest betahistine has salutary effects on food intake or metabolism in humans, these studies will lay the groundwork for additional investigations to assess the efficacy of betahistine in the treatment of obesity.
- Conditions
- Obesity, Overweight, Overnutrition
- Being tested
- Betahistine Hydrochloride
- Keywords
- Obesity, Weight Gain, Adult, Histamine, Metabolism, Overweight
- Medical subject headings
- Obesity, Overweight, Overnutrition, Weight Gain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Betahistine HydrochlorideDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in food intake and appetite with betahistine treatment.
Secondary outcomes (1)
Gut hormone assessment with betahistine treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2007 (estimated)
- Study start10 Apr 2007
- Primary completion14 Feb 2011
- Study completion14 Feb 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Sponsor type
- US National Institutes of Health
- Investigators
- Jack A Yanovski, M.D., Principal investigator, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00459992
- Sponsor's protocol ID
- 070126
- Other IDs
- 07-CH-0126
- Status last verified
- 11 Dec 2014
- First submitted
- 12 Apr 2007
- Last updated
- 16 Dec 2019
- Results posted
- No
Publications
Hedley AA, Ogden CL, Johnson CL, Carroll MD, Curtin LR, Flegal KM. Prevalence of overweight and obesity among US children, adolescents, and adults, 1999-2002. JAMA. 2004 Jun 16;291(23):2847-50. doi: 10.1001/jama.291.23.2847.
PubMed 15199035Ogden CL, Carroll MD, Curtin LR, McDowell MA, Tabak CJ, Flegal KM. Prevalence of overweight and obesity in the United States, 1999-2004. JAMA. 2006 Apr 5;295(13):1549-55. doi: 10.1001/jama.295.13.1549.
PubMed 16595758Vidal J. Updated review on the benefits of weight loss. Int J Obes Relat Metab Disord. 2002 Dec;26 Suppl 4:S25-8. doi: 10.1038/sj.ijo.0802215.
PubMed 12457296Pietila TK, Cantini E, Itkonen ST, Salonen A, Pajari AM. Replacing red meat with non-soy legumes alters choline metabolites but not systemic inflammation or proxies of gut barrier function in healthy males in a 6-week RCT. J Nutr Biochem. 2026 Aug;154:110355. doi: 10.1016/j.jnutbio.2026.110355. Epub 2026 Mar 27.
PubMed 41905546Ballenger KL, Tugarinov N, Talvacchio SK, Knue MM, Dang Do AN, Ahlman MA, Reynolds JC, Yanovski JA, Marini JC. Osteogenesis Imperfecta: The Impact of Genotype and Clinical Phenotype on Adiposity and Resting Energy Expenditure. J Clin Endocrinol Metab. 2022 Jan 1;107(1):67-76. doi: 10.1210/clinem/dgab679.
PubMed 34519823Ali AH, Yanoff LB, Stern EA, Akomeah A, Courville A, Kozlosky M, Brady SM, Calis KA, Reynolds JC, Crocker MK, Barak N, Yanovski JA. Acute effects of betahistine hydrochloride on food intake and appetite in obese women: a randomized, placebo-controlled trial. Am J Clin Nutr. 2010 Dec;92(6):1290-7. doi: 10.3945/ajcn.110.001586. Epub 2010 Sep 29.
PubMed 20881066
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study of the Metabolic Effects of Betahistine Hydrochloride in Overweight Women
- ClinicalTrials.gov ID
- NCT00459992
- Acronym / sponsor ID
- 070126
- Conditions
- Obesity, Overweight, Overnutrition
- Keywords
- Obesity, Weight Gain, Adult, Histamine, Metabolism, Overweight
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)US National Institutes of Health
- Study start
- 10 Apr 2007
- Primary completion
- 14 Feb 2011 (actual)
- Study completion
- 14 Feb 2011 (actual)
- First posted
- 13 Apr 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 evaluate the effects of a drug called betahistine on appetite and food intake in overweight women. Betahistine has been used for many years to treat vertigo (dizziness). It was taken off the market in the United States in 1970 because it was thought to be ineffective for vertigo, but is still used for this purpose in many other countries. Some research suggests that betahistine may reduce appetite and food intake.
Healthy overweight women between 18 and 50 years of age may be eligible for this study. Candidates must have a body mass index (BMI) between 30 and 40 and weigh less than 300 pounds. They are screened with a medical history and physical examination, blood and urine tests, electrocardiogram (EKG), breathing test and eating behavior questionnaires.
Participants are admitted to the NIH Clinical Center for a 3-day/2-night stay for the following procedures:
- Medication: Subjects take either betahistine (in one of three possible doses) or placebo capsules one time on the days of admission to the Clinical Center (day 1), three times on day 2 and two times on day 3.
- Blood tests and 24-hour urine collection.
- Resting metabolic rate: Subjects rest quietly for 1 hour after awakening and then rest again under a clear plastic hood or while wearing a face mask, breathing normally for about 25 minutes.
- DEXA scan to measure body fat, muscle, and bone mineral content: Subjects lie on a table above a source of X-rays while a very small dose of X-rays is passed through the body.
- Meal studies: Subjects food intake is measured on days 2 and 3.
- Questionnaires: Subjects complete questionnaires about how hungry or full they are feeling and rate how much they liked the foods they ate.
Detailed description
Current medications for the long-term treatment of obesity are moderately effective at best. Therefore, research focusing on compounds that affect energy balance through novel mechanisms is warranted. Preliminary human and animal data suggest central nervous system histaminergic tone is important in the regulation of food intake. We therefore propose to study the effects of betahistine hydrochloride, a histamine analogue which has agonist activity at the histaminergic H1 receptor and antagonist/reverse agonist activity at the H3 receptor. Prior animal studies have suggested that betahistine suppresses food intake and reduces body weight, but there are sparse human data assessing the effects of betahistine on metabolism.
Betahistine s effects on women s food intake and metabolism will be evaluated through an inpatient randomized double-blind placebo controlled dose-ranging study. We will examine the acute effects of betahistine on food intake, hunger, and satiety, resting energy expenditure, and on hormones and substrates relevant for body weight regulation. If results suggest betahistine has salutary effects on food intake or metabolism in humans, these studies will lay the groundwork for additional investigations to assess the efficacy of betahistine in the treatment of obesity.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Good general health. In general, subjects will be required to take no medications. However, individuals taking medications for obesity-related co-morbid conditions, who have not had changes in dosage for more than 6 months, may be included, at the discretion of the principal investigator.
- Age 18-50 years.
- Female sex. In this pilot study, we seek to decrease the variability of subject response to the greatest extent possible. Since women have a higher prevalence of obesity than men, and tend to be the group that most uses weight loss pharmacotherapy, we will only study women in the pilot investigation. Subsequent studies with include both sexes.
- Regular menses (either spontaneous or as a result of oral contraceptive pills) or post-menopausal status (no menses for at least 3 months).
- Obesity, defined as body mass index (BMI) between 30 and 40 kg/m(2) but weight under 300 lbs, in order for subject to be able to undergo DEXA scanning with the Hologic instrument available in the Nuclear Medicine Department.
Key exclusion criteria (16 listed)
- Volunteers will be excluded (and referred to non-experimental treatment programs as needed) for the following reasons:
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 |
|---|---|---|
| Betahistine Hydrochloride | Drug | – |
Primary outcome
Changes in food intake and appetite with betahistine treatment.
1 secondary outcome
Gut hormone assessment with betahistine treatment.
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 16 Dec 2019.
- Background: PubMed 15199035Hedley AA, Ogden CL, Johnson CL, Carroll MD, Curtin LR, Flegal KM. Prevalence of overweight and obesity among US children, adolescents, and adults, 1999-2002. JAMA. 2004 Jun 16;291(23):2847-50. doi: 10.1001/jama.291.23.2847.
- Background: PubMed 16595758Ogden CL, Carroll MD, Curtin LR, McDowell MA, Tabak CJ, Flegal KM. Prevalence of overweight and obesity in the United States, 1999-2004. JAMA. 2006 Apr 5;295(13):1549-55. doi: 10.1001/jama.295.13.1549.
- Background: PubMed 12457296Vidal J. Updated review on the benefits of weight loss. Int J Obes Relat Metab Disord. 2002 Dec;26 Suppl 4:S25-8. doi: 10.1038/sj.ijo.0802215.
- Derived from this study: PubMed 41905546Pietila TK, Cantini E, Itkonen ST, Salonen A, Pajari AM. Replacing red meat with non-soy legumes alters choline metabolites but not systemic inflammation or proxies of gut barrier function in healthy males in a 6-week RCT. J Nutr Biochem. 2026 Aug;154:110355. doi: 10.1016/j.jnutbio.2026.110355. Epub 2026 Mar 27.
- Derived from this study: PubMed 34519823Ballenger KL, Tugarinov N, Talvacchio SK, Knue MM, Dang Do AN, Ahlman MA, Reynolds JC, Yanovski JA, Marini JC. Osteogenesis Imperfecta: The Impact of Genotype and Clinical Phenotype on Adiposity and Resting Energy Expenditure. J Clin Endocrinol Metab. 2022 Jan 1;107(1):67-76. doi: 10.1210/clinem/dgab679.
- Derived from this study: PubMed 20881066Ali AH, Yanoff LB, Stern EA, Akomeah A, Courville A, Kozlosky M, Brady SM, Calis KA, Reynolds JC, Crocker MK, Barak N, Yanovski JA. Acute effects of betahistine hydrochloride on food intake and appetite in obese women: a randomized, placebo-controlled trial. Am J Clin Nutr. 2010 Dec;92(6):1290-7. doi: 10.3945/ajcn.110.001586. Epub 2010 Sep 29.
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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.
Jack A Yanovski, M.D. principal investigator
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Betahistine Hydrochloride in people with Obesity and Overweight, run by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) 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 8 inclusion and 16 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 16 Dec 2019. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Changes in food intake and appetite with betahistine treatment.. 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 NCT00459992, which also lists 6 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 16 Dec 2019.