Oxytocin and Eating

Study Overview
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Brief Summary
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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.

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

Conditions
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Weight Gain

Intervention / Treatment
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* Drug: Syntocinon
* Drug: Placebos


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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appetite regulation, obesity, oxytocin