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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Dyslipidemias

Intervention / Treatment
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* Drug: Mega Resveratrol® capsules
* Drug: Mega Resveratrol® Placebo capsules


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 35 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: placebo<br>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 | Drug: Mega Resveratrol® Placebo capsules<br>* Mega Resveratrol® Placebo capsules<br>|
| Experimental: 100mg/d resveratrol<br>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 | Drug: Mega Resveratrol® capsules<br>* Subjects were orally administered Mega Resveratrol® capsules daily for 8 weeks.<br>|
| Experimental: 300mg/d resveratrol<br>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 | Drug: Mega Resveratrol® capsules<br>* Subjects were orally administered Mega Resveratrol® capsules daily for 8 weeks.<br>|
| Experimental: 600mg/d resveratrol<br>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 | Drug: Mega Resveratrol® capsules<br>* Subjects were orally administered Mega Resveratrol® capsules daily for 8 weeks.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |