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

Mass General Brigham logo

Mass General Brigham

Status and phase

Completed
Early Phase 1

Conditions

Eating Behavior

Treatments

Drug: Placebo
Drug: Oxytocin

Study type

Interventional

Funder types

Other

Identifiers

NCT01513499
MGH1004

Details and patient eligibility

About

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

Enrollment

25 patients

Sex

All

Ages

18 to 45 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Other

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Quadruple Blind

25 participants in 2 patient groups, including a placebo group

Oxytocin
Active Comparator group
Description:
Intranasal oxytocin
Treatment:
Drug: Oxytocin
Placebo
Placebo Comparator group
Description:
Intranasal placebo
Treatment:
Drug: Placebo

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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