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Completed

NCT Number: NCT04886297

A Dose-response Study of Dietary Resveratrol on Lipid Metabolism Disorder

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.

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Key information

Conditions

Dyslipidemias Lipid Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

35 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Sun Yat-Sen University

Guangzhou, Guangdong, China

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Dyslipidemia
  • The age between 35 and 70 years old

Exclusion criteria

  • 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

Treatment and study plan

Mega Resveratrol® capsules

Drug

Subjects were orally administered Mega Resveratrol® capsules daily for 8 weeks.

Mega Resveratrol® Placebo capsules

Drug

Mega Resveratrol® Placebo capsules

Primary outcomes

  1. Effect of resveratrol on lipid profile in patients with dyslipidemia

    Time frame: 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.

Secondary outcomes

  1. Effect of resveratrol on uric acid and xanthine oxidase in patients with dyslipidemia

    Time frame: Change from Baseline to 4 weeks and 8 weeks

    Uric acid concentration and xanthine oxidase activity will be measured by automatic biochemical analyzer and commercial kits, respectively.

Sponsors and collaborators

Lead sponsor

Sun Yat-sen University

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
May 14, 2021
Registry last updated
Oct 27, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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