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临床试验/NCT02622490
NCT02622490Unknown不适用

Diet-induced Thermogenesis 2

University Hospital, Linkoeping2 个研究点 分布在 1 个国家目标入组 28 人开始时间: 2015年9月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
发起方
入组人数
28
试验地点
2
主要终点
Metabolic rate

研究概览

简要总结

About thirty participants, of varying degrees of obesity or being non-obese, without serious concomitant diseases consume either a high- or a low- carbohydrate beverage. The beverage is also consumed either as one single drink or as 5 small portions in the morning and are tested for effects on major cardiovascular risk markers and on metabolic rate for three hours on each occasion.

详细描述

Thirty participants come to the metabolic ward at about 8 o´clock in the fasting state and stay until lunch on four occasions each. The participants are randomized to the order of the test meals. The meals have a total caloric content of 750 kcal and have either 50% of energy from carbohydrates (low fat) or 20% of energy from carbohydrates (low carb.). The meals are consumed on one occasion in the morning or divided in 5 portions (150 kcal each) for every 30 minutes, i.e. total combinations of meal composition and of meal distribution is 4. Effects of the food on p-glucose, s-insulin, blood-lipids, hormones and on metabolic rate is measured by blood tests or by indirect calorimetry (for metabolic rate). Sense of satiety is measured by visual analogue scales.

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
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Healthy participants > 18 years with or without obesity

排除标准

  • Major illnesses,
  • thyroid diseases,
  • need to take prednisolone,
  • psychiatric disease,
  • inability to understand Swedish

研究组 & 干预措施

High carb. one meal

Active Comparator

Intervention: One meal of 750 kcal with 50 % of energy content from carbohydrates

干预措施: two test meals with two different macronutrient compositions (Other)

Low carb. one meal

Active Comparator

Intervention: One meal of 750 kcal with 20 % of energy content from carbohydrates

干预措施: two test meals with two different macronutrient compositions (Other)

Low Carb. 5 small meals

Active Comparator

Intervention: Five meals every 30 minutes of 150 kcal/each with 20 % of energy content from carbohydrates.

干预措施: two test meals with two different macronutrient compositions (Other)

High carb. 5 meals

Experimental

Intervention: Five meals every 30 minutes of 150 kcal/each with 50 % of energy content from carbohydrates.

干预措施: two test meals with two different macronutrient compositions (Other)

结局指标

主要结局

Metabolic rate

时间窗: During about 3 hours

The metabolic rate is measured before (baseline) and there after repeatedly during 3 hours

次要结局

  • Effects on glucose and insulin(3 hours)

研究者

发起方
University Hospital, Linkoeping
申办方类型
Other
责任方
Principal Investigator
主要研究者

Fredrik H Nystrom

professor, MD

University Hospital, Linkoeping

研究点 (2)

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