Overview

This trial is active, not recruiting.

Condition eating behavior
Treatments oxytocin, placebo
Phase phase 0
Sponsor Massachusetts General Hospital
Start date January 2012
End date January 2017
Trial size 140 participants
Trial identifier NCT01513499, MGH1004

Summary

Exciting advances have led to the concept that hormones can modulate appetite and food intake. Oxytocin is a peptide hormone that is released in regions throughout the brain, including areas involved in food motivation. Animal studies suggest that oxytocin may reduce food intake. The effects of oxytocin administration on eating behavior in humans, which could have important implications in eating-related disorders ranging from obesity to anorexia nervosa, have not been investigated. This double-blind placebo-controlled cross-over study of single-dose oxytocin administration investigates whether:

1. Caloric intake will decrease following administration of oxytocin versus placebo

2. Appetite will decrease following administration of oxytocin versus placebo

3. Resting energy expenditure will increase following administration of oxytocin versus placebo

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model crossover assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Arm
(Active Comparator)
Intranasal oxytocin
oxytocin Syntocinon (Novartis)
Intranasal oxytocin 24 IU single-dose administration
(Placebo Comparator)
Intranasal placebo
placebo
Intranasal Placebo single-dose administration

Primary Outcomes

Measure
Caloric intake
time frame: +60 minutes after drug/placebo

Secondary Outcomes

Measure
Appetite
time frame: +55 (fasting) and +90 minutes (post-prandial) after drug/placebo
Resting energy expenditure
time frame: +30 minutes after drug/placebo

Eligibility Criteria

Male or female participants from 18 years up to 45 years old.

Inclusion Criteria: - 18-45 years old - BMI 18.5-24.9, 25-40 - Regular breakfast eater (at least 4 times per week) - Stable weight within the past three months Exclusion Criteria: - Psychiatric disease - Use of psychotropic medications - History of eating disorder - History of excessive exercise within the last three months - History of diabetes mellitus - Active substance abuse - Hematocrit below normal range - Gastrointestinal tract surgery (including gastrectomy, gastric bypass surgery, and small or large bowel resection) - History of cardiovascular disease (such as hypertrophic cardiomyopathy, valvular heart disease, coronary heart disease, or coronary artery spasms) - Untreated thyroid disease - Tobacco use

Additional Information

Official title Effect of Intranasal Oxytocin on Appetite and Caloric Intake in Humans
Principal investigator Elizabeth A Lawson, MD
Trial information was received from ClinicalTrials.gov and was last updated in July 2016.
Information provided to ClinicalTrials.gov by Massachusetts General Hospital.