Effect of Intranasal Oxytocin on Appetite and Caloric Intake in Humans
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Caloric intake
研究概览
简要总结
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Oxytocin
Intranasal oxytocin
干预措施: Oxytocin (Drug)
Placebo
Intranasal placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Caloric intake
时间窗: +60 minutes after drug/placebo
次要结局
- Appetite(+55 (fasting) and +90 minutes (post-prandial) after drug/placebo)
- Resting energy expenditure(+30 minutes after drug/placebo)
研究者
Elizabeth Austen Lawson
Assistant in Medicine
Massachusetts General Hospital