Oxytocin and Eating

July 18, 2017 updated by: Yale-NUS College

Exploring the Effects of Oxytocin on Appetite Regulation in Healthy Adult Men

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Singapore
      • Singapore, Singapore, 138527
        • Yale-NUS College

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 45 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: BASIC_SCIENCE
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Oxytocin
Participants will receive two doses of 24 IU intra-nasal oxytocin (Syntocinon) in a single session
Drug: Syntocinon
Intra-nasal oxytocin
PLACEBO_COMPARATOR: Placebo
Participants will received match placebo, again in two doses in a single session
Drug: Placebos
Intra-nasal placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Taste sensitivity
Time Frame: 2-hour span following oxytocin administration
Taste thresholds for primary taste senses, measured using psychophysical staircase procedures
2-hour span following oxytocin administration
Taste preference
Time Frame: 2-hour span following oxytocin administration

Measured using the positive/negative generalised Labeled Magnitude Scale used to

assess pleasantness
2-hour span following oxytocin administration
Value placed upon food
Time Frame: 2-hour span following oxytocin administration
Willingness to pay for food (vs non-food items) in a Becker-DeGroot-Marschak auction task
2-hour span following oxytocin administration

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Subjective ratings of hunger and fullness
Time Frame: 2-hour span following oxytocin administration
Measured using 100-point Visual Analogue Scales
2-hour span following oxytocin administration

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yale-NUS College

Collaborators

Singapore General Hospital
SingHealth Investigational Medicine Unit

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

September 1, 2017

Primary Completion (ANTICIPATED)

December 1, 2018

Study Completion (ANTICIPATED)

January 1, 2019

Study Registration Dates

First Submitted

July 17, 2017

First Submitted That Met QC Criteria

July 18, 2017

First Posted (ACTUAL)

July 21, 2017

Study Record Updates

Last Update Posted (ACTUAL)

July 21, 2017

Last Update Submitted That Met QC Criteria

July 18, 2017

Last Verified

July 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IG15-LR052

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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