Oxytocin and Eating

NCT ID: NCT03225456

Last Updated: 2017-07-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-09-30

Study Completion Date

2019-01-31

Brief Summary

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In this protocol, the investigators propose a randomised controlled trial to explore the effects of intra-nasal oxytocin administration on appetite regulation. The investigators will run a cross-over design with 60 healthy adult men.

Detailed Description

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Conditions

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Weight Gain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Oxytocin

Participants will receive two doses of 24 IU intra-nasal oxytocin (Syntocinon) in a single session

Group Type EXPERIMENTAL

Syntocinon

Intervention Type DRUG

Intra-nasal oxytocin

Placebo

Participants will received match placebo, again in two doses in a single session

Group Type PLACEBO_COMPARATOR

Placebos

Intervention Type DRUG

Intra-nasal placebo

Interventions

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Syntocinon

Intra-nasal oxytocin

Intervention Type DRUG

Placebos

Intra-nasal placebo

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Gender: Male
* Age: 21-45 years
* Normal weight: Body mass index of 18.5 to 22.9
* Have had a stable weight for the past 3 months (less than 5kg)
* Have regular breakfast meals (≥ 4 times a week of self-reported consumption of a breakfast meal)
* Have habitual sleep of 6.5-8.5 hours
* Have English as first language (or fluent in spoken and written English)

Exclusion Criteria

* Symptoms / history of any major medical condition, including:

* Bariatric surgery or surgical obesity treatment
* Diabetes
* Cardiovascular disease
* Thyroid disease
* Anaemia
* Psychiatric disorders
* Eating disorders
* Excessive exercise (running \> 40 km or exercising \> 10 hr in a week)
* Currently on a special diet or trying deliberately to restrict food intake
* Currently on a weight loss program
* Smoking or substance abuse
* Use of medications that can affect weight (e.g., steroids, approved weight-loss drugs)
Minimum Eligible Age

21 Years

Maximum Eligible Age

45 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Singapore General Hospital

OTHER

Sponsor Role collaborator

SingHealth Investigational Medicine Unit

UNKNOWN

Sponsor Role collaborator

Yale-NUS College

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Yale-NUS College

Singapore, , Singapore

Site Status

Countries

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Singapore

Other Identifiers

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IG15-LR052

Identifier Type: -

Identifier Source: org_study_id

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