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临床试验/NCT04886297
NCT04886297已完成3 期

Department of Nutrition and Food Hygiene,School of Public Health, Sun Yat-sen University

Sun Yat-sen University1 个研究点 分布在 1 个国家目标入组 168 人开始时间: 2021年5月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
3 期
状态
已完成
发起方
入组人数
168
试验地点
1
主要终点
Effect of resveratrol on lipid profile in patients with dyslipidemia

研究概览

简要总结

In order to study the effect of resveratrol on the improvement of lipid and uric acid metabolism, randomized intervention trials were conducted to compare the effects of resveratrol on the improvement of lipid and uric acid metabolism in different dose groups. To explore the best dose of resveratrol for the prevention and treatment of metabolic diseases provide an important scientific basis.

详细描述

In order to study the effect of resveratrol on the improvement of lipid and uric acid metabolism, randomized controlled trials were conducted to enrolled 160 patients with dyslipidemia. The subjects were divided into 0 mg / d, 100 mg / d, 300 mg / d, 600 mg/ d four dose groups, intervention for 8 weeks, comparing different doses of resveratrol on lipid and uric acid metabolism. To explore the best dose of resveratrol for the prevention and treatment of metabolic diseases provide an important scientific basis.

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
35 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Dyslipidemia
  • The age between 35 and 70 years old

排除标准

  • Intake of any medicine that affect lipid metabolism currently or in the preceding 6 months
  • Dietary supplementation with phytochemicals including resveratrol in the preceding 3 months
  • History of acute or chronic infectious disease, autoimmune disease, cancer, traumatic injury, or surgery in the preceding 1 month
  • History of severe chronic disease including AS and CVD, liver or renal dysfunction, and lactation or pregnancy
  • Pregnant woman and Breast Feeding Women

研究组 & 干预措施

placebo

Placebo Comparator

The placebo capsules only contained pullulan and maltodextrin. During the trial period, the participants were instructed to consume two Mega Resveratrol® placebo capsules once daily (30 min after breakfast).

Intervention: Drug: Mega Resveratrol® capsules

干预措施: Mega Resveratrol® Placebo capsules (Drug)

100mg/d resveratrol

Experimental

During the trial period, the participants will be instructed to consume one Mega Resveratrol® capsules and one Mega Resveratrol® placebo capsules 30 min after breakfast. The resveratrol capsules (100 mg anthocyanins per capsule) will provid a total daily intake of 100 mg resveratrol.

Intervention: Drug: Mega Resveratrol® capsules

干预措施: Mega Resveratrol® capsules (Drug)

300mg/d resveratrol

Experimental

During the trial period, the participants will be instructed to consume one Mega Resveratrol® capsules and one Mega Resveratrol® placebo capsules 30 min after breakfast. The resveratrol capsules (300 mg anthocyanins per capsule) will provid a total daily intake of 300 mg resveratrol.

Intervention: Drug: Mega Resveratrol® capsules

干预措施: Mega Resveratrol® capsules (Drug)

600mg/d resveratrol

Experimental

During the trial period, the participants will be instructed to consume two Mega Resveratrol® capsules 30 min after breakfast. The resveratrol capsules (300 mg anthocyanins per capsule, 2 per day) will provid a total daily intake of 600 mg resveratrol.

Intervention: Drug: Mega Resveratrol® capsules

干预措施: Mega Resveratrol® capsules (Drug)

结局指标

主要结局

Effect of resveratrol on lipid profile in patients with dyslipidemia

时间窗: Change from Baseline to 4 weeks and 8 weeks

Lipid profile in serum will be measured, mainly including TC, TG, LDL-C and HDL-C, by automatic biochemical analyzer.

次要结局

  • Effect of resveratrol on uric acid and xanthine oxidase in patients with dyslipidemia(Change from Baseline to 4 weeks and 8 weeks)

研究者

发起方
Sun Yat-sen University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Zhou Yuqing

Principal Investigator

Sun Yat-sen University

研究点 (1)

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