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临床试验/NCT02247596
NCT02247596已完成2 期

Effects of High-Dose Resveratrol on Resting Energy Expenditure and HOMA in Non-Diabetic Obese Males

Khoo Teck Puat Hospital1 个研究点 分布在 1 个国家目标入组 36 人开始时间: 2009年7月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
2 期
状态
已完成
入组人数
36
试验地点
1
主要终点
Change from baseline in Resting Energy Expenditure via indirect calorimetry at 2 weeks

研究概览

简要总结

The primary aim of our study was to examine the effects of two weeks of oral resveratrol on resting energy expenditure and insulin sensitivity in non-diabetic obese male subjects. Secondary variables included plasma lipid subfraction, blood pressure and glycated hemoglobin (HbA1c).

详细描述

Patients were recruited between July 2009 and July 2012 from a single hospital in Singapore. Eligible patients were Chinese males, aged between 21 and 55 years old, with a body mass index (BMI) of 30 kg/m2 or more and venous glucose of <7.0 and <11.1 mmol/L at 0 and 120 minutes respectively on oral glucose tolerance testing (OGTT) following a 12-hour fast. They must be willing to abstain from embarking on an exercise regime or ingesting large quantities of resveratrol-containing foods including alcohol during the study period.

The study was a randomized, double-blind, parallel group trial consisting of a screening visit, a two-week treatment period and a post-treatment visit.

Randomization was centrally performed during treatment assignment with a 2-digit reference code placed in sealed opaque envelopes maintained by the person responsible for the preparation of the intervention drug and placebo. Trans-resveratrol extract from Polygonum Cuspidatum (Mega Resveratrol, Danbury, USA) was used in the trial. The placebo was not distinguishable by color, form, or taste from the active drug. The randomization code was unblinded only after all predefined data were recorded.

Subjects were given 1g three times a day of either resveratrol or placebo for two weeks and instructed to abstain from foods with high resveratrol content during the entire duration of the trial. Compliance was determined by pill counting at the end of the trial period. Subjects in both arms were not allowed to commence on an exercise regimen or supplements during the study period. Subjects who dropped out of the trial would not be replaced. All variables were measured at baseline and at the end of the treatment period.

RMR was measured by indirect calorimetry using a breath-by-breath metabolic gas analyser via the face-mask method.

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
Double (Participant, Investigator)

入排标准

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

入选标准

  • Ability to give informed consent
  • Obese Chinese Male
  • Age 21 to 55 yrs old
  • No diabetes mellitus
  • BMI of 30 kg/m2 or more during screening

排除标准

  • Unwilling to abstain from ingesting large quantities of resveratrol-containing foods (eg. red wine, nuts)
  • Cancer diagnosis that is currently under treatment, is clinically detectable, or that has been treated within the past 5 years
  • Terminal disease or on palliative care
  • Current excessive alcohol intake (>21 units per week for men; 14 units per week for women)
  • Known diabetes mellitus
  • Past history of unexplained hypoglycemia
  • Past or current history of strokes
  • History of any grape allergy
  • On alternative or traditional medications
  • Treated with another investigational drug within last 6 months
  • Poorly controlled hypertension (SBP >/= 160 or DBP >/= 100) within last one month
  • ALT and/or AST > 1.5 times above upper limit of normal within last 6 months
  • GFR < 50 ml/min/1.73m2 (MDRD equation) within last 6 months
  • Staff of Department of Medicine, Khoo Teck Puat Hospital

研究组 & 干预措施

Placebo

Placebo Comparator

Sugar pill 1g tds for 2 weeks

干预措施: Placebo (Drug)

Resveratrol

Experimental

Trans-resveratrol extract from Polygonum Cuspidatum 1g three times a day for 2 weeks

干预措施: Resveratrol (Drug)

结局指标

主要结局

Change from baseline in Resting Energy Expenditure via indirect calorimetry at 2 weeks

时间窗: 2 weeks (pre and post intervention)

Measured in Kcal/day using a metabolic cart

次要结局

  • Change from baseline in Glycated hemoglobin at 2 weeks(2 weeks (pre and post intervention))
  • Change from baseline in insulin resistance via Homeostasis Model Assessment (HOMA) 2 calculator at 2 weeks(2 weeks (pre and post intervention))
  • Change from baseline in lipid subfractions at 2 weeks(2 weeks (pre and post intervention))
  • Change from baseline in Blood pressure at 2 weeks(2 weeks (pre and post intervention))

研究者

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

Goh Kian Peng

PI

Khoo Teck Puat Hospital

研究点 (1)

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