The Impact of Weight Loss Through Alternate Day Fasting on Homeostatic and Hedonic Appetite Control and Eating Behaviour: a Proof of Concept Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 54
- 试验地点
- 2
- 主要终点
- Change in energy intake from ad libitum lunch
研究概览
简要总结
The aim of this study is to test the hypothesis that dietary weight loss (WL) through alternate day fasting (ADF) will enhance appetite control, health markers and wellbeing following WL compared to standard daily calorie restriction (CR).
详细描述
This is a proof of concept randomized controlled trial in which overweight/obese females will be randomised to a dietary weight loss intervention (ADF or CR) to achieve ≥5% WL. Behavioural measures of appetite control including ad libitum intake after a fixed meal, body composition, resting metabolic rate, measured physical activity and daily energy expenditure, sleep quality, hedonic food reward and eating behaviour traits will be assessed before, during and after the WL intervention in those who reach the target weight loss within 12 weeks. After weight loss phase, participants will be given standard healthy eating and physical activity advice for weight maintenance and body weight will be followed up after weight loss at 12 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Female participants aged between 18 and 55 years at the time of signing informed consent
- •BMI of 25.0 - 34.9 kg/m2
排除标准
- •Significant health problems which in the opinion of the investigator, might jeopardise participant's safety or compliance with the protocol
- •Currently enrolled in a weight loss programme or following a specific diet plan.
- •History of eating disorders including binge eating.
- •Taking any medication or supplements known to affect appetite or weight within the past month and/or during the study
- •Pregnant, planning to become pregnant or breastfeeding
- •History of anaphylaxis to food
- •Known food allergies or food intolerance
- •Smokers and those who have recently ceased smoking (< 6 months)
- •BMI < 24.9 kg/m2 or > 35 kg/m2
- •Volunteers having lost significant amount of weight in the previous 6 months (± 4kg)
- •Volunteers who exercise > 3 days per week or have significantly changed their physical activity patterns in the past 6 months or who intend to change them during the study
- •Participants receiving systemic or local treatment likely to interfere with evaluation of the study parameters
- •Participants who work in appetite or feeding related areas.
- •Participants who do shift work
结局指标
主要结局
Change in energy intake from ad libitum lunch
时间窗: week 0, week 3 and at study completion, an average of 12 weeks
Measured changes in ad-libitum energy intake following consumption of formulated test meal in comparison to control
次要结局
- Change in explicit liking of food from Leeds Food Preference Questionnaire(week 0, week 3 and at study completion, an average of 12 weeks)
- Change in Visual Analogue Scale (VAS) ratings of appetite(week 0, week 3 and at study completion, an average of 12 weeks)
- Change in Control of Eating Questionnaire (CoEQ) scale scores(week 0, week 3 and at study completion, an average of 12 weeks)
- Change in explicit wanting of food from Leeds Food Preference Questionnaire scores(week 0, week 3 and at study completion, an average of 12 weeks)
- Change in relative preference of food from Leeds Food Preference Questionnaire scores(week 0, week 3 and at study completion, an average of 12 weeks)
- Change in implicit wanting of food from Leeds Food Preference Questionnaire scores(week 0, week 3 and at study completion, an average of 12 weeks)
- Change in free-living physical activity(week 0, week 3 and at study completion, an average of 12 weeks)
- Change in VAS rating of palatability post lunch(week 0, week 3 and at study completion, an average of 12 weeks)
- Change in fat mass(week 0, week 3 and at study completion, an average of 12 weeks)
- Change in fat free mass(week 0, week 3 and at study completion, an average of 12 weeks)
- Change in resting metabolic rate(week 0, week 3 and at study completion, an average of 12 weeks)
研究者
Dr Graham Finlayson
Chair in Psychobiology
University of Leeds