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临床试验/NCT02169778
NCT02169778已完成不适用

Effect of Intermittent Versus Continuous Energy Restriction on Compensatory Mechanisms Activated During Weight Reduction

Norwegian University of Science and Technology1 个研究点 分布在 1 个国家目标入组 34 人开始时间: 2013年8月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
34
试验地点
1
主要终点
Appetite related hormones

研究概览

简要总结

Obesity has become a global epidemic with huge public health implications. Although clinical significant weight loss can be achieved by a combination of diet and behavioral modification, strong metabolic adaptations, with increased appetite and suppressed energy expenditure, are activated, which compromise weight loss maintenance and increase the risk of relapse. The aim of this project is to compare the effects of intermittent versus continuous energy restriction on the compensatory responses previously described using two low calory diets, with a similar macronutrient distribution. More specifically, this study will analyze, in the short-term, if an intermittent energy restricted diet is associated with less appetite and low reduction in energy expenditure when compared with a continuous energy restricted diet. This project can bring large practical benefits concerning the design of weight loss programs to minimize weight relapse.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 50 Years(Adult)
性别
All
接受健康志愿者
是

入选标准

  • •adult (18-50 years old)
  • •obese healthy volunteers (30<BMI<40 kg/m2)
  • •weight stable on the last three months (<2kg), not currently dieting to lose weight and with an inactive lifestyle

排除标准

  • •history of endocrine/cardiovascular/pulmonary/kidney disease
  • •milk intolerance
  • •depression or other psychological disorders
  • •eating disorders
  • •drug or alcohol abuse within the last two years
  • •current medication known to affect appetite or induce weight loss
  • •a planned surgery during the study period
  • •participating in another research study

研究组 & 干预措施

Intermittent energy restricted diet

Experimental

The intermittent energy restricted group will undergo 3 nonconsecutive days of partial fasting per week. During the 3 days of partial fasting, participants will be asked to consume a very-low calorie diet (VLCD) providing 550kcal/day for women and 650kcal/day for men. The VLCD products provide 110kcal/pack and include a variety of shakes, smoothies and soups. For the feeding days a diet matching energy needs will be prescribed, using meal replacements (such as smoothies, soups and cereal bars) and conventional food. Drinking at least 2.5 liters of non-caloric liquids will be recommended.

干预措施: Intermittent energy restricted diet (Behavioral)

Continuous energy restricted diet

Experimental

The continuous energy restricted group will be prescribed a low calorie diet (LCD) with 33% energy restriction, using meal replacements (such as smoothies, soups and cereal bars) and conventional food. The diets' macronutrient composition of the two groups will be matched (50% carbohydrates, 20% protein and 30% fat).

干预措施: Continuous energy restricted diet (Behavioral)

结局指标

主要结局

Appetite related hormones

时间窗: 12 weeks after the intervention

Appetite-related hormones (active Ghrelin, PYY, GLP-1, CCK) will be measured in fasting and every 30 minutes up to 2,5 hours.

次要结局

  • Body composition(At 1 year from baseline)
  • Resting metabolic rate (RMR)(12 weeks after the intervention)
  • Exercise efficiency(12 weeks after the intervention)
  • Body composition(12 weeks after the intervention)
  • Body composition(At 6 months from baseline)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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