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Oxytocin and Eating

Primary Purpose

Weight Gain

Status
Unknown status
Phase
Phase 2
Locations
Singapore
Study Type
Interventional
Intervention
Syntocinon
Placebos
Sponsored by
Yale-NUS College
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Weight Gain focused on measuring appetite regulation, obesity, oxytocin

Eligibility Criteria

21 Years - 45 Years (Adult)MaleAccepts Healthy Volunteers

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)

Sites / Locations

  • Yale-NUS College

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Oxytocin

Placebo

Arm Description

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

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

Outcomes

Primary Outcome Measures

Taste sensitivity
Taste thresholds for primary taste senses, measured using psychophysical staircase procedures
Taste preference
Measured using the positive/negative generalised Labeled Magnitude Scale used to assess pleasantness
Value placed upon food
Willingness to pay for food (vs non-food items) in a Becker-DeGroot-Marschak auction task

Secondary Outcome Measures

Subjective ratings of hunger and fullness
Measured using 100-point Visual Analogue Scales

Full Information

First Posted
July 17, 2017
Last Updated
July 18, 2017
Sponsor
Yale-NUS College
Collaborators
Singapore General Hospital, SingHealth Investigational Medicine Unit
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1. Study Identification

Unique Protocol Identification Number
NCT03225456
Brief Title
Oxytocin and Eating
Official Title
Exploring the Effects of Oxytocin on Appetite Regulation in Healthy Adult Men
Study Type
Interventional

2. Study Status

Record Verification Date
July 2017
Overall Recruitment Status
Unknown status
Study Start Date
September 2017 (Anticipated)
Primary Completion Date
December 2018 (Anticipated)
Study Completion Date
January 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yale-NUS College
Collaborators
Singapore General Hospital, SingHealth Investigational Medicine Unit

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Weight Gain
Keywords
appetite regulation, obesity, oxytocin

7. Study Design

Primary Purpose
Basic Science
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Oxytocin
Arm Type
Experimental
Arm Description
Participants will receive two doses of 24 IU intra-nasal oxytocin (Syntocinon) in a single session
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Participants will received match placebo, again in two doses in a single session
Intervention Type
Drug
Intervention Name(s)
Syntocinon
Intervention Description
Intra-nasal oxytocin
Intervention Type
Drug
Intervention Name(s)
Placebos
Intervention Description
Intra-nasal placebo
Primary Outcome Measure Information:
Title
Taste sensitivity
Description
Taste thresholds for primary taste senses, measured using psychophysical staircase procedures
Time Frame
2-hour span following oxytocin administration
Title
Taste preference
Description
Measured using the positive/negative generalised Labeled Magnitude Scale used to assess pleasantness
Time Frame
2-hour span following oxytocin administration
Title
Value placed upon food
Description
Willingness to pay for food (vs non-food items) in a Becker-DeGroot-Marschak auction task
Time Frame
2-hour span following oxytocin administration
Secondary Outcome Measure Information:
Title
Subjective ratings of hunger and fullness
Description
Measured using 100-point Visual Analogue Scales
Time Frame
2-hour span following oxytocin administration

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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)
Facility Information:
Facility Name
Yale-NUS College
City
Singapore
ZIP/Postal Code
138527
Country
Singapore

12. IPD Sharing Statement

Plan to Share IPD
No

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Oxytocin and Eating

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