Effect of Intranasal Oxytocin on Appetite and Caloric Intake in Men and Women

Eating Behavior Clinical Trial

Official title:

Effect of Intranasal Oxytocin on Appetite and Caloric Intake in Humans

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01513499
• Other study ID #: MGH1004
• Status: Completed
• Phase: Early Phase 1
• Start date: January 2012
• Est. completion date: January 2014

Study information

• Verified date: April 2019
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: January 2014
• Est. primary completion date: January 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Eating Behavior

Intervention

Drug:
• Oxytocin
Intranasal oxytocin 24 IU single-dose administration
• Placebo
Intranasal Placebo single-dose administration

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Massachusetts General Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Caloric intake		+60 minutes after drug/placebo
Secondary	Appetite	Assessed using a Visual Analogue Scale	+55 (fasting) and +90 minutes (post-prandial) after drug/placebo
Secondary	Resting energy expenditure	Assessed using metabolic cart	+30 minutes after drug/placebo