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临床试验/NCT04025346
NCT04025346已完成不适用

A Randomized, Double-blind, Placebo-controlled, Cross-over Study to Evaluate the Efficacy of Capsimax on Metabolic Rate

Vedic Lifesciences Pvt. Ltd.2 个研究点 分布在 1 个国家目标入组 44 人开始时间: 2019年10月17日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
44
试验地点
2
主要终点
Effect of Investigational Product on Resting Energy Expenditure

研究概览

简要总结

Capsimax™ is a proprietary Capsicum Extract that employs Beadlet Technology. In the previous study it has been used to investigate its effect in reducing body fat/weight and increase metabolic rate. In this study, Capsimax™ will be used to assess effect on Resting Energy Expenditure (REE) using Indirect Calorimetry.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Other
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 55 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Healthy, adult, male/female participants with age ≥ 18 ≤ 55 years.
  • A Body Mass Index (BMI) between 18.5 to 29.9 kg/m
  • Fasting blood sugar ≤ 100 mg/dl
  • Hemoglobin: Males ≥ 11 g/dl and Females ≥ 10 g/dl
  • BP < 140/90 mmHg

排除标准

  • Post-menopausal females
  • History of hypo/ hyperthyroidism.
  • History of significant neurological or psychiatric condition such as seizures, depression, or insomnia.

结局指标

主要结局

Effect of Investigational Product on Resting Energy Expenditure

时间窗: From baseline to 4 hours.

Assessed by Indirect Calorimetry

次要结局

未报告次要终点

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (2)

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