Effect of Intranasal Oxytocin on Appetite and Caloric Intake in Men and Women

Study Overview
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Brief Summary
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Exciting advances have led to the concept that hormones can modulate appetite and food intake. Oxytocin is a peptide hormone that is released in regions throughout the brain, including areas involved in food motivation. Animal studies suggest that oxytocin may reduce food intake. The effects of oxytocin administration on eating behavior in humans, which could have important implications in eating-related disorders ranging from obesity to anorexia nervosa, have not been investigated. This double-blind placebo-controlled cross-over study of single-dose oxytocin administration investigates whether: Caloric intake will decrease following administration of oxytocin versus placebo Appetite will decrease following administration of oxytocin versus placebo Resting energy expenditure will increase following administration of oxytocin versus placebo

Official Title
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Effect of Intranasal Oxytocin on Appetite and Caloric Intake in Humans

Conditions
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Eating Behavior

Intervention / Treatment
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* Drug: Oxytocin
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18-45 years old BMI 18.5-24.9, 25-40 Regular breakfast eater (at least 4 times per week) Stable weight within the past three months Exclusion Criteria: Psychiatric disease Use of psychotropic medications History of eating disorder History of excessive exercise within the last three months History of diabetes mellitus Active substance abuse Hematocrit below normal range Gastrointestinal tract surgery (including gastrectomy, gastric bypass surgery, and small or large bowel resection) History of cardiovascular disease (such as hypertrophic cardiomyopathy, valvular heart disease, coronary heart disease, or coronary artery spasms) Untreated thyroid disease Tobacco use

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

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: Other
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Oxytocin<br>Intranasal oxytocin | Drug: Oxytocin<br>* Intranasal oxytocin 24 IU single-dose administration<br>* Other names: Syntocinon (Novartis);|
| Placebo Comparator: Placebo<br>Intranasal placebo | Drug: Placebo<br>* Intranasal Placebo single-dose administration<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Caloric intake |  | +60 minutes after drug/placebo | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Appetite | Assessed using a Visual Analogue Scale | +55 (fasting) and +90 minutes (post-prandial) after drug/placebo | 
| Resting energy expenditure | Assessed using metabolic cart | +30 minutes after drug/placebo | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Eating behavior, Appetite, Oxytocin, Neuropeptide