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

Phase 3
Completed
Conditions
Dyslipidemias
Interventions
Registration Number
NCT04886297
Lead Sponsor
Sun Yat-sen University
Brief 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.

Detailed 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 & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
168
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

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
300mg/d resveratrolMega Resveratrol® capsulesDuring 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
600mg/d resveratrolMega Resveratrol® capsulesDuring 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
placeboMega Resveratrol® Placebo capsulesThe 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
100mg/d resveratrolMega Resveratrol® capsulesDuring 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
Primary Outcome Measures
NameTimeMethod
Effect of resveratrol on lipid profile in patients with dyslipidemiaChange 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 Outcome Measures
NameTimeMethod
Effect of resveratrol on uric acid and xanthine oxidase in patients with dyslipidemiaChange 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.

Trial Locations

Locations (1)

Sun Yat-Sen University

🇨🇳

Guangzhou, Guangdong, China

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