Oxytocin and Eating

NCT03225456 | Unknown Phase 2

• 1 other identifier: IG15-LR052
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Weight Gain

Keywords

appetite regulation; obesity; oxytocin

Outcome Measures

Primary Outcomes (3)

• Taste sensitivity

  Taste thresholds for primary taste senses, measured using psychophysical staircase procedures

  2-hour span following oxytocin administration

• Taste preference

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

  2-hour span following oxytocin administration

• 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 Outcomes (1)

• Subjective ratings of hunger and fullness

  2-hour span following oxytocin administration

Study Arms (2)

Oxytocin

EXPERIMENTAL

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

Drug: Syntocinon

Placebo

PLACEBO COMPARATOR

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

Drug: Placebos

Interventions

Syntocinon DRUG

Intra-nasal oxytocin

Oxytocin

Placebos DRUG

Intra-nasal placebo

Placebo

Eligibility Criteria

• Age: 21 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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)

Sponsors & Collaborators

• Yale-NUS College: lead
• Singapore General Hospital: collaborator
• SingHealth Investigational Medicine Unit: collaborator

Study Sites (1)

Yale-NUS College

Singapore, 138527, Singapore

Location

MeSH Terms

Conditions

Weight Gain; Obesity

Interventions

Oxytocin

Condition Hierarchy (Ancestors)

Body Weight Changes; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Pituitary Hormones, Posterior; Pituitary Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 17, 2017
• First Posted: July 21, 2017
• Study Start: September 1, 2017
• Primary Completion: December 1, 2018
• Study Completion: January 1, 2019
• Last Updated: July 21, 2017

Record last verified: 2017-07

Data Sharing

• IPD Sharing: Will not share

Locations

SG (1)