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OpenTrials
Completed

NCT Number: NCT01513499

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

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

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Key information

Conditions

Eating Behavior Behavior Behavior, Animal Feeding Behavior

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Oxytocin

Drug

Intranasal oxytocin 24 IU single-dose administration

Other names: Syntocinon (Novartis)

Placebo

Drug

Intranasal Placebo single-dose administration

Primary outcomes

  1. Caloric intake

    Time frame: +60 minutes after drug/placebo

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Registry information

Official study title

Effect of Intranasal Oxytocin on Appetite and Caloric Intake in Humans

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Jan 20, 2012
Registry last updated
Apr 8, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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