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临床试验/NCT01773356
NCT01773356已完成不适用

Randomized, Controlled, Parallel Trial to Evaluate the Effects of Dihydrocapsiate on Energy Expenditure in Women

Ellen Evans1 个研究点 分布在 1 个国家目标入组 126 人开始时间: 2011年1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
发起方
入组人数
126
试验地点
1
主要终点
Resting Energy Expenditure

研究概览

简要总结

The objective of this study is to test the effect of dihydrocapsiate on energy expenditure in women.

详细描述

Capsaicin, a substance found in chili pepper, is known to stimulate thermogenesis. Dihydrocapsiate, a capsinoid, found in the non-pungent CH-19 sweet pepper has similar thermogenic effects without the gastrointestinal side effects. The objective of this project is to test the effect of 12 weeks of daily consumption of 9 mg dihydrocapsiate on resting energy expenditure relative to baseline when compared to a control group consuming products without DCT.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Double (Participant, Investigator)

入排标准

年龄范围
25 Years 至 45 Years(Adult)
性别
Female
接受健康志愿者
是

入选标准

  • •BMI: 18.5-34.5 kg/m2
  • •Good general health
  • •Low to mild physical activity
  • •Willing to maintain habitual diet and physical activity patterns throughout the study period
  • •Premenopausal and cycling regularly or using oral contraceptives
  • •Willing to attend study visits only during the follicular phase or bleed phase of their menstrual cycle
  • •Understands study procedures and signs forms providing informed consent to participate in the study
  • •Have spoken and written English literacy

排除标准

  • •Diabetes mellitus or any conditions that might affect energy metabolism
  • •Weight change ±2 kg over previous three months
  • •Known sensitivity or allergy to ingredients of the study products
  • •Non-breakfast eater
  • •Recent use of antibiotics
  • •History of smoking during the six months prior to study
  • •Recent signs or symptoms of infection, including cold or flu-like symptoms
  • •Concurrent or recent intervention study participation
  • •Instability in breathing patterns or energy expenditure measures
  • •History of drug or alcohol abuse
  • •Lipid-lowering, anti-hypertensive or anti-inflammatory steroid medication use
  • •Weight loss medication
  • •Pregnant or lactating
  • •Unwilling to be randomized to any experimental group and unable to meet all requirements of the study

研究组 & 干预措施

Dihydrocapsiate 9 mg/d

Active Comparator

9 mg/d of Dihydrocapsiate will be consumed in ready to ear cereal, cereal bars or crackers

干预措施: Dihydrocapsiate (Dietary Supplement)

Placebo 0 mg/d

Placebo Comparator

0 mg/d of Dihydrocapsiate will be consumed in ready to ear cereal, cereal bars or crackers

干预措施: Dihydrocapsiate (Dietary Supplement)

结局指标

主要结局

Resting Energy Expenditure

时间窗: Change from Baseline at 12 weeks

次要结局

  • Thermic effect of feeding(Change from baseline at 12 weeks)
  • Body Composition(Change from baseline at 12 weeks)

研究者

发起方
Ellen Evans
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Ellen Evans

Dr Ellen Evans

University of Georgia

研究点 (1)

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