A randomized, double-blind, placebo-controlled clinical trial of 8-week intranasal oxytocin administration in adults with obesity: Rationale, study design, and methods.
Appetite regulation
Energy metabolism
Neuroimaging
Obesity
Oxytocin
Weight loss
Journal
Contemporary clinical trials
ISSN: 1559-2030
Titre abrégé: Contemp Clin Trials
Pays: United States
ID NLM: 101242342
Informations de publication
Date de publication:
11 2022
11 2022
Historique:
received:
22
06
2022
revised:
28
08
2022
accepted:
02
09
2022
pubmed:
11
9
2022
medline:
16
11
2022
entrez:
10
9
2022
Statut:
ppublish
Résumé
Obesity affects more than one-third of adults in the U.S., and effective treatment options are urgently needed. Oxytocin administration induces weight loss in animal models of obesity via effects on caloric intake, energy expenditure, and fat metabolism. We study intranasal oxytocin, an investigational drug shown to reduce caloric intake in humans, as a potential novel treatment for obesity. We report the rationale, design, methods, and biostatistical analysis plan of a randomized, double-blind, placebo-controlled clinical trial of intranasal oxytocin for weight loss (primary endpoint) in adults with obesity. Participants (aged 18-45 years) were randomly allocated (1:1) to oxytocin (four times daily over eight weeks) versus placebo. Randomization was stratified by biological sex and BMI (30 to <35, 35 to <40, ≥40 kg/m Sixty-one male and female participants aged 18-45 years were randomized (mean age 34 years, mean BMI 37 kg/m Investigating intranasal oxytocin's efficacy, safety, and mechanisms as an anti-obesity medication will advance the search for optimal treatment strategies for obesity and its associated severe sequelae.
Sections du résumé
BACKGROUND
Obesity affects more than one-third of adults in the U.S., and effective treatment options are urgently needed. Oxytocin administration induces weight loss in animal models of obesity via effects on caloric intake, energy expenditure, and fat metabolism. We study intranasal oxytocin, an investigational drug shown to reduce caloric intake in humans, as a potential novel treatment for obesity.
METHODS
We report the rationale, design, methods, and biostatistical analysis plan of a randomized, double-blind, placebo-controlled clinical trial of intranasal oxytocin for weight loss (primary endpoint) in adults with obesity. Participants (aged 18-45 years) were randomly allocated (1:1) to oxytocin (four times daily over eight weeks) versus placebo. Randomization was stratified by biological sex and BMI (30 to <35, 35 to <40, ≥40 kg/m
RESULTS
Sixty-one male and female participants aged 18-45 years were randomized (mean age 34 years, mean BMI 37 kg/m
CONCLUSION
Investigating intranasal oxytocin's efficacy, safety, and mechanisms as an anti-obesity medication will advance the search for optimal treatment strategies for obesity and its associated severe sequelae.
Identifiants
pubmed: 36087842
pii: S1551-7144(22)00235-X
doi: 10.1016/j.cct.2022.106909
pmc: PMC10329413
mid: NIHMS1903909
pii:
doi:
Substances chimiques
Oxytocin
50-56-6
Types de publication
Randomized Controlled Trial
Journal Article
Research Support, N.I.H., Extramural
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
106909Subventions
Organisme : NIMH NIH HHS
ID : K24 MH120568
Pays : United States
Organisme : NIDDK NIH HHS
ID : P30 DK040561
Pays : United States
Organisme : NIDDK NIH HHS
ID : P30 DK046200
Pays : United States
Organisme : NIDDK NIH HHS
ID : R01 DK109932
Pays : United States
Informations de copyright
Copyright © 2022. Published by Elsevier Inc.
Déclaration de conflit d'intérêts
Declaration of Competing Interest The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: E.A.L. served on the scientific advisory board and has a financial interest in OXT Therapeutics, Inc. E.A.L. also received funding for an investigator-initiated study by Tonix Pharmaceuticals. All other authors declare no conflicts of interest.
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