Oxytocin and Eating

Phase 2

• Conditions: Weight Gain
• Interventions: Drug: Placebos; Drug: Syntocinon

• Registration Number: NCT03225456
• Lead Sponsor: Yale-NUS College

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2017-07
• Study First Submitted: 2017-07-17
• Study First Submitted QC: 2017-07-18
• Last Update Submitted: 2017-07-18
• Study First Posted: 2017-07-21
• Last Update Posted: 2017-07-21
• Study Start: 2017-09
• Primary Completion: 2018-12
• Study Completion: 2019-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Male
• Target Recruitment: 60

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Placebo	Placebos	Participants will received match placebo, again in two doses in a single session
Oxytocin	Syntocinon	Participants will receive two doses of 24 IU intra-nasal oxytocin (Syntocinon) in a single session

Primary Outcome Measures

Name	Time	Method
Taste sensitivity	2-hour span following oxytocin administration	Taste thresholds for primary taste senses, measured using psychophysical staircase procedures
Value placed upon food	2-hour span following oxytocin administration	Willingness to pay for food (vs non-food items) in a Becker-DeGroot-Marschak auction task
Taste preference	2-hour span following oxytocin administration	Measured using the positive/negative generalised Labeled Magnitude Scale used to; assess pleasantness

Secondary Outcome Measures

Name	Time	Method
Subjective ratings of hunger and fullness	2-hour span following oxytocin administration	Measured using 100-point Visual Analogue Scales

Trial Locations

Locations (1)

Yale-NUS College; 🇸🇬 Singapore, Singapore