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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Elizabeth Austen Lawson, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT01513499
First received: January 11, 2012
Last updated: May 28, 2014
Last verified: October 2013
  Purpose

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

Condition Intervention
Eating Behavior
Drug: Oxytocin
Drug: Placebo

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Official Title: Effect of Intranasal Oxytocin on Appetite and Caloric Intake in Humans

Resource links provided by NLM:


Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:
  • Caloric intake [ Time Frame: +60 minutes after drug/placebo ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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


Estimated Enrollment: 140
Study Start Date: January 2012
Estimated Study Completion Date: January 2016
Estimated Primary Completion Date: January 2016 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Oxytocin
    Intranasal oxytocin 24 IU single-dose administration
    Other Name: Syntocinon (Novartis)
    Drug: Placebo
    Intranasal Placebo single-dose administration
  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01513499

Locations
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Massachusetts General Hospital
Investigators
Principal Investigator: Elizabeth A Lawson, MD Massachusetts General Hospital
  More Information

No publications provided

Responsible Party: Elizabeth Austen Lawson, Assistant in Medicine, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT01513499     History of Changes
Other Study ID Numbers: MGH1004
Study First Received: January 11, 2012
Last Updated: May 28, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Massachusetts General Hospital:
Eating behavior
Appetite
Oxytocin
Neuropeptide

Additional relevant MeSH terms:
Oxytocin
Oxytocics
Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on July 31, 2014