NCT01513499

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. 1.Caloric intake will decrease following administration of oxytocin versus placebo
  2. 2.Appetite will decrease following administration of oxytocin versus placebo
  3. 3.Resting energy expenditure will increase following administration of oxytocin versus placebo

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at P25-P50 for early_phase_1

Timeline
Completed

Started Jan 2012

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2012

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

January 11, 2012

Completed
9 days until next milestone

First Posted

Study publicly available on registry

January 20, 2012

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2014

Completed
Last Updated

April 8, 2019

Status Verified

April 1, 2019

Enrollment Period

2 years

First QC Date

January 11, 2012

Last Update Submit

April 4, 2019

Conditions

Eating Behavior

Keywords

Eating behaviorAppetiteOxytocinNeuropeptide

Outcome Measures

Primary Outcomes (1)

  • Caloric intake

    +60 minutes after drug/placebo

Secondary Outcomes (2)

  • Appetite

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

  • Resting energy expenditure

    +30 minutes after drug/placebo

Study Arms (2)

Oxytocin

ACTIVE COMPARATOR

Intranasal oxytocin

Drug: Oxytocin

Placebo

PLACEBO COMPARATOR

Intranasal placebo

Drug: Placebo

Interventions

OxytocinDRUG

Intranasal oxytocin 24 IU single-dose administration

Also known as: Syntocinon (Novartis)
Oxytocin
PlaceboDRUG

Intranasal Placebo single-dose administration

Placebo

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

MeSH Terms

Conditions

Feeding Behavior

Interventions

Oxytocinlactitol

Condition Hierarchy (Ancestors)

Behavior, AnimalBehavior

Intervention Hierarchy (Ancestors)

Pituitary Hormones, PosteriorPituitary HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPeptidesAmino Acids, Peptides, and Proteins

Study Officials

  • Elizabeth A Lawson, MD

    Massachusetts General Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant in Medicine

Study Record Dates

First Submitted

January 11, 2012

First Posted

January 20, 2012

Study Start

January 1, 2012

Primary Completion

January 1, 2014

Study Completion

January 1, 2014

Last Updated

April 8, 2019

Record last verified: 2019-04

Locations

US(1)