Oxytocin and Eating

Weight Gain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03225456
• Other study ID #: IG15-LR052
• Status: Not yet recruiting
• Phase: Phase 2
• First received: July 17, 2017
• Last updated: July 18, 2017
• Start date: September 2017
• Est. completion date: January 2019

Study information

• Verified date: July 2017
• Source: Yale-NUS College
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: January 2019
• Est. primary completion date: December 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 21 Years to 45 Years

Eligibility

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)

Related Conditions & MeSH terms

• Weight Gain

Intervention

Drug:
• Syntocinon
Intra-nasal oxytocin
• Placebos
Intra-nasal placebo

Locations

Country	Name	City	State
Singapore	Yale-NUS College	Singapore

Sponsors (3)

Lead Sponsor	Collaborator
Yale-NUS College	Singapore General Hospital, SingHealth Investigational Medicine Unit

Country where clinical trial is conducted

Singapore, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Taste sensitivity	Taste thresholds for primary taste senses, measured using psychophysical staircase procedures	2-hour span following oxytocin administration
Primary	Taste preference	Measured using the positive/negative generalised Labeled Magnitude Scale used to; assess pleasantness	2-hour span following oxytocin administration
Primary	Value placed upon food	Willingness to pay for food (vs non-food items) in a Becker-DeGroot-Marschak auction task	2-hour span following oxytocin administration
Secondary	Subjective ratings of hunger and fullness	Measured using 100-point Visual Analogue Scales	2-hour span following oxytocin administration