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临床试验/NCT03652207
NCT03652207已完成不适用

The Effects of Palatinose™ on Weight Management and Body Composition in Overweight and Obese Individuals

Beneo-Institute2 个研究点 分布在 1 个国家目标入组 64 人开始时间: 2009年4月20日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
64
试验地点
2
主要终点
Body Weight Change

研究概览

简要总结

The study aims to assess body weight and body composition changes in overweight and obese persons consuming an energy-reduced diet containing foods with either sucrose or isomaltulose (Palatinose(TM)) over a period of 3 months.

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
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Subject is healthy at the time of pre-examination
  • Subject has a BMI of 25 - 35 kg/m² and motivated to lose weight
  • Subject is aged 18 - 60 years at the time of pre-examination

排除标准

  • Person suffers from an acute or chronic disease
  • Person has known dietary restrictions or allergies to Foods
  • Intake of medications which interfere with body composition, appetite, satiety or food intake

结局指标

主要结局

Body Weight Change

时间窗: 12 weeks

Body weight Change over a 12-week period

次要结局

  • Body fat percentage(12 weeks)
  • Waist circumference(12 weeks)
  • BMI(12 weeks)
  • postprandial respiratory quotient (RQ)(120 minutes postprandial)

研究者

发起方
Beneo-Institute
申办方类型
Industry
责任方
Sponsor

研究点 (2)

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