Exploring the Effects of Oxytocin on Appetite Regulation in Healthy Adult Men
试验速览
- 阶段
- 2 期
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Taste sensitivity
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 21 Years 至 45 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •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)
排除标准
- •Symptoms / history of any major medical condition, including:
- •Bariatric surgery or surgical obesity treatment
- •Cardiovascular disease
- •Thyroid disease
- •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)
研究组 & 干预措施
Oxytocin
Participants will receive two doses of 24 IU intra-nasal oxytocin (Syntocinon) in a single session
干预措施: Syntocinon (Drug)
Placebo
Participants will received match placebo, again in two doses in a single session
干预措施: Placebos (Drug)
结局指标
主要结局
Taste sensitivity
时间窗: 2-hour span following oxytocin administration
Taste thresholds for primary taste senses, measured using psychophysical staircase procedures
Value placed upon food
时间窗: 2-hour span following oxytocin administration
Willingness to pay for food (vs non-food items) in a Becker-DeGroot-Marschak auction task
Taste preference
时间窗: 2-hour span following oxytocin administration
Measured using the positive/negative generalised Labeled Magnitude Scale used to assess pleasantness
次要结局
- Subjective ratings of hunger and fullness(2-hour span following oxytocin administration)