Acute effects of betahistine hydrochloride on food intake and appetite in obese women: a randomized, placebo-controlled trial1234

Background: Central nervous system histaminergic tone is thought to play a role in appetite regulation. In animal models, histamine receptor 1 (HRH1) agonists and histamine receptor 3 (HRH3) antagonists decrease food intake.Objective: The objective of this study was to examine the acute effects of b...

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Published inThe American journal of clinical nutrition Vol. 92; no. 6; pp. 1290 - 1297
Main Authors Ali, Asem H, Yanoff, Lisa B, Stern, Elizabeth A, Akomeah, Abena, Courville, Amber, Kozlosky, Merel, Brady, Sheila M, Calis, Karim A, Reynolds, James C, Crocker, Melissa K, Barak, Nir, Yanovski, Jack A
Format Journal Article
LanguageEnglish
Published Elsevier Inc 01.12.2010
American Society for Nutrition
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Summary:Background: Central nervous system histaminergic tone is thought to play a role in appetite regulation. In animal models, histamine receptor 1 (HRH1) agonists and histamine receptor 3 (HRH3) antagonists decrease food intake.Objective: The objective of this study was to examine the acute effects of betahistine hydrochloride (an HRH1 agonist and HRH3 antagonist) on food intakes and appetites.Design: The study was a proof-of-concept, randomized, double-blinded, placebo-controlled, dose-ranging study performed to examine the effects of betahistine in women with class I or II obesity [body mass index (BMI; in kg/m2) of 30–39.99]. After a 24-h placebo run-in period, subjects received a placebo (n = 19) or 48 (n = 19), 96 (n = 17), or 144 (n = 21) mg betahistine/d for 24 h. Treatment was followed by a buffet test meal to assess energy intake. Hunger, satiety, and desire to eat were measured after consuming the meal by using visual analog scales. Data were analyzed by using regression models with the assumption that there would be an increasing effect of betahistine doses. Analyses were adjusted for age, log fat and lean mass, food preferences, and intake during a buffet test meal obtained during the placebo run-in period.Results: Of the 79 obese women (mean ± SD age: 42 ± 11 y; BMI: 35 ± 3) enrolled in the study, 76 women completed the study. The betahistine dose did not significantly change intakes from those observed during the run-in period of the buffet test meal (P = 0.78). Hunger, fullness, and desire to eat (all P > 0.62) similarly showed no differences according to the betahistine dose.Conclusions: Betahistine did not produce an effect on food intakes or appetites. More potent histaminergic modulators may be required to elucidate the possible role of histaminergic pathways in human obesity. This trial was registered at clinicaltrials.gov as NCT00459992
Bibliography:AHA and LBY contributed equally to this study.
Supported by the National Institutes of Health (NIH) Intramural Research Program, grant Z01-HD-00641 from the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), with supplemental funding from the NIH Office of Research on Women's Health (to JAY), and by a cooperative research agreement with Obecure Ltd to the NICHD (to JAY). Obecure Ltd provided some research support for the study and the betahistine and matching placebo capsules under a material transfer agreement with the NICHD. The study was designed, implemented, and data were analyzed and interpreted independent of Obecure Ltd; however, the manuscript was reviewed and approved by NB, who is an employee of Obecure Ltd.
ISSN:0002-9165
1938-3207
DOI:10.3945/ajcn.110.001586