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Effect of Intranasal Oxytocin on Appetite and Caloric Intake in Men

This study is currently recruiting participants.
Verified May 2013 by Massachusetts General Hospital
Sponsor:
Information provided by (Responsible Party):
Elizabeth Austen Lawson, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT01513499
First received: January 11, 2012
Last updated: May 14, 2013
Last verified: May 2013
History of Changes

January 11, 2012
May 14, 2013
January 2012
January 2014   (final data collection date for primary outcome measure)
Caloric intake [ Time Frame: +60 minutes after drug/placebo ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01513499 on ClinicalTrials.gov Archive Site
  • Appetite [ Time Frame: +55 (fasting) and +90 minutes (post-prandial) after drug/placebo ] [ Designated as safety issue: No ]
    Assessed using a Visual Analogue Scale
  • Resting energy expenditure [ Time Frame: +30 minutes after drug/placebo ] [ Designated as safety issue: No ]
    Assessed using metabolic cart
Same as current
Not Provided
Not Provided
 
Effect of Intranasal Oxytocin on Appetite and Caloric Intake in Men
Effect of Intranasal Oxytocin on Appetite and Caloric Intake in Humans

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
Not Provided
Interventional
Not Provided
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Eating Behavior
  • Drug: Oxytocin
    Intranasal oxytocin 24 IU single-dose administration
    Other Name: Syntocinon (Novartis)
  • Drug: Placebo
    Intranasal Placebo single-dose administration
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
30
January 2014
January 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • 18-45 years old
  • BMI 18.5-24.9, 30-40
  • 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
Male
18 Years to 45 Years
Yes
Contact: Elizabeth A Lawson, MD 617-726-3870 ealawson@partners.org
United States
 
NCT01513499
MGH1004
No
Elizabeth Austen Lawson, Massachusetts General Hospital
Massachusetts General Hospital
Not Provided
Principal Investigator: Elizabeth A Lawson, MD Massachusetts General Hospital
Massachusetts General Hospital
May 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP