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临床试验/NCT04651023
NCT04651023已完成不适用

Shanghai Meiji Health Science and Technology Co., Ltd

Shanghai Meiji Health Science and Technology Co., Ltd.0 个研究点目标入组 95 人开始时间: 2009年1月10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
95
主要终点
Changes in anthropometrix indices during the study

研究概览

简要总结

Investigators performed a randomized double-blind trial to determine the effects of long-term NnEx ingestion in patients with overweight or obesity. Ninety-five participants (23<BMI<30 kg/m2) were randomly allocated to three groups: a control group, a 1 g/day NnEx group, and a 2 g/day NnEx group. The effects of the consumption of 2 g/day or 1 g/day NnEx for 12 weeks on indices of adiposity and fasting blood metabolic parameters were compared with those of no consumption of NnEx.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
Double (Participant, Care Provider)

入排标准

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

入选标准

  • Has a body mass index (BMI) of 23-30 kg/m2
  • Has no history of using any antidiabetic medication
  • Absence of liver, kidney, or heart disease
  • Absence of food allergy and daily tea consumption <2 L
  • Meet all of the above criteria and to follow the instructions given during the study.

排除标准

  • Testing delayed for >1 week without justification
  • Difficulty attending the hospital on the required days
  • Lack of data regarding the times of beverage consumption for over 5% of the study
  • Abnormal overeating
  • Test results believed to be unreliable because of the lack of provision of diet and exercise reports during the fasting period
  • Difficulty drawing blood
  • Poor confidence in the test data

结局指标

主要结局

Changes in anthropometrix indices during the study

时间窗: baseline, 6 weeks, 12 weeks

weight in kilograms

次要结局

  • Changes in fasting biochemical indices during the study(baseline, 6 weeks, 12 weeks)

研究者

申办方类型
Industry
责任方
Principal Investigator
主要研究者

Zai-Si Ji, phD

Principal Investigator

Shanghai Meiji Health Science and Technology Co., Ltd.

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