The purpose of the study is to determine the effect of intranasal OXT caloric intake and eating behaviors in otherwise healthy obese adolescents. The primary objective of this study is to determine the effects of intranasal administration of oxytocin on food intake in obese, pubertal or post-pubertal adolescents (13 to \<18 years in girls, and 15 to \<20 years in boys).
Participants will undergo a telephone screening and then, within 4 weeks, complete an in-person screening visit to determine eligibility. Then, within 4 weeks they will be randomized to either OXT or placebo. After a minimum 1-week (7-28 days) "washout," participants will cross-over to treatment with the other condition (i.e., placebo or OXT).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
The active substance of Syntocinon is a synthetic nonapeptide identical to the posterior pituitary hormone oxytocin.
The placebo is identical to the Syntocinon formulation with the exception of the active compound, i.e., without oxytocin.
Effect on Food Intake
Kilocalories Consumed at as desired ('Ad Lib') Test Meal
Time frame: 28 Days
Adverse Events
Number of participants with adverse events.
Time frame: 28 Days
Effect of OXT on Eating Behaviors at Mealtime (appetite)
Investigators will assess appetite, a visual analog scale (VAS) to quantify participants' self-reported appetite on a linear scale will be used. The range of the VAS is 0% to 100% of the scale, with 0% corresponding to no self-reported appetite, and 100% corresponding to maximal self-reported appetite.
Time frame: 28 Days
Effect of OXT on Eating Behaviors at Mealtime (impulsivity)
Investigators will measure impulsivity, which may affect the decision to eat, performance on a computerized stop-signal task will be assessed. Outcome measures include: direction errors (#, more = more errors), proportion of successful stops (%, higher = more successful), reaction time on "Go" trials (longer = slower), stop signal reaction time (longer= slower).
Time frame: 28 Days
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