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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01513499
Recruitment Status : Active, not recruiting
First Posted : January 20, 2012
Last Update Posted : May 1, 2017
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief 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

Condition or disease Intervention/treatment Phase
Eating Behavior Drug: Oxytocin Drug: Placebo Early Phase 1

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 140 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Other
Official Title: Effect of Intranasal Oxytocin on Appetite and Caloric Intake in Humans
Study Start Date : January 2012
Estimated Primary Completion Date : January 2018
Estimated Study Completion Date : January 2018

Resource links provided by the National Library of Medicine

Drug Information available for: Oxytocin
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Active Comparator: Oxytocin
Intranasal oxytocin
Drug: Oxytocin
Intranasal oxytocin 24 IU single-dose administration
Other Name: Syntocinon (Novartis)
Placebo Comparator: Placebo
Intranasal placebo
Drug: Placebo
Intranasal Placebo single-dose administration


Outcome Measures

Primary Outcome Measures :
  1. Caloric intake [ Time Frame: +60 minutes after drug/placebo ]

Secondary Outcome Measures :
  1. Appetite [ Time Frame: +55 (fasting) and +90 minutes (post-prandial) after drug/placebo ]
    Assessed using a Visual Analogue Scale

  2. Resting energy expenditure [ Time Frame: +30 minutes after drug/placebo ]
    Assessed using metabolic cart


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Elizabeth Austen Lawson, Assistant in Medicine, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT01513499     History of Changes
Other Study ID Numbers: MGH1004
First Posted: January 20, 2012    Key Record Dates
Last Update Posted: May 1, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Elizabeth Austen Lawson, Massachusetts General Hospital:
Eating behavior
Appetite
Oxytocin
Neuropeptide

Additional relevant MeSH terms:
Oxytocin
Oxytocics
Reproductive Control Agents
Physiological Effects of Drugs