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NCT04886297 Clinical Trial

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

Dyslipidemias Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04886297
Other study ID # lwh87331597
Secondary ID
Status Completed
Phase Phase 3
First received
Last updated
Start date May 1, 2021
Est. completion date September 30, 2022

Study information
Verified date October 2022
Source Sun Yat-sen University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility
Status Completed
Enrollment 168
Est. completion date September 30, 2022
Est. primary completion date May 30, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 35 Years to 70 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Mega Resveratrol® capsules
Subjects were orally administered Mega Resveratrol® capsules daily for 8 weeks.
• Mega Resveratrol® Placebo capsules
Mega Resveratrol® Placebo capsules

Locations
Country Name City State
China Sun Yat-Sen University Guangzhou Guangdong

Sponsors (1)
Lead Sponsor Collaborator
Sun Yat-sen University

Country where clinical trial is conducted

China, 

Outcome
Type Measure Description Time frame Safety issue
Primary Effect of resveratrol on lipid profile in patients with dyslipidemia Lipid profile in serum will be measured, mainly including TC, TG, LDL-C and HDL-C, by automatic biochemical analyzer. Change from Baseline to 4 weeks and 8 weeks
Secondary Effect of resveratrol on uric acid and xanthine oxidase in patients with dyslipidemia Uric acid concentration and xanthine oxidase activity will be measured by automatic biochemical analyzer and commercial kits, respectively. Change from Baseline to 4 weeks and 8 weeks
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