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Effects of Betahistine Hydrochloride in Overweight Women

NCT00459992 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2019-12-16

No results posted yet for this study

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). 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.

Conditions

Interventions

DRUG

Betahistine Hydrochloride

Sponsors & Collaborators

  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

    lead NIH

Principal Investigators

  • Jack A Yanovski, M.D. · Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-04-10
Primary Completion
2011-02-14
Completion
2011-02-14

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00459992 on ClinicalTrials.gov