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CompletedNCT01513499Updated Apr 8, 2019

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

An Early Phase 1 interventional study of Oxytocin and Placebo in Eating Behavior, sponsored by Massachusetts General Hospital. Completed at 1 site in United States. Open to participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-04-08.

Sponsored by Massachusetts General Hospital · Early Phase 1, Interventional, and Other

Phase
Early Phase 1
Study type
Interventional
Enrollment
25
Allocation
Randomized
Ages
18 Years to 45 Years
Sex
All
01

Study 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
02

Conditions studied

  • Eating Behavior

Keywords

  • Eating behavior
  • Appetite
  • Oxytocin
  • Neuropeptide
03

In context

Lead sponsor

Massachusetts General Hospital is the lead sponsor of 2,536 studies on the registry; 446 are open to participants now.

Of its 214 completed or terminated interventional studies of FDA-regulated products, 161 (75%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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
05

Study design

Phase
Early Phase 1
Primary purpose
Other
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
25 participants (actual)

Study arms

  • Active comparator
    Oxytocin

    Intranasal oxytocin

    Drug: Oxytocin

  • Placebo comparator
    Placebo

    Intranasal placebo

    Drug: Placebo

Interventions

  • DrugOxytocin

    Intranasal oxytocin 24 IU single-dose administration

    Also known as: Syntocinon (Novartis)

  • DrugPlacebo

    Intranasal Placebo single-dose administration

06

What researchers measure

Primary outcomes

  1. Caloric intake

    Time frame: +60 minutes after drug/placebo

Secondary outcomes

  1. Appetite

    Assessed using a Visual Analogue Scale

    Time frame: +55 (fasting) and +90 minutes (post-prandial) after drug/placebo

  2. Resting energy expenditure

    Assessed using metabolic cart

    Time frame: +30 minutes after drug/placebo

07

Study locations

1 site
  • Massachusetts General Hospital
    Boston, Massachusetts 02114, United States
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 8, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01513499
Lead sponsor
Massachusetts General Hospital
Responsible party
Elizabeth Austen Lawson (Assistant in Medicine, Massachusetts General Hospital) — Principal investigator
First posted
Jan 20, 2012
Start date
Jan 2012
Primary completion
Jan 2014
Completion
Jan 2014
Last update
Apr 8, 2019

Study contacts

Elizabeth A Lawson, MD
principal investigator · Massachusetts General Hospital

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2019. You cannot join it, but the record below documents what was studied.

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