Back to resultsA Dose-response Study of Dietary Resveratrol on Lipid Metabolism Disorder
Primary Purpose
Dyslipidemias
Status
Completed
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
Mega Resveratrol® capsules
Mega Resveratrol® Placebo capsules
Sponsored by
About this trial
This is an interventional prevention trial for Dyslipidemias
Eligibility Criteria
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
Sites / Locations
- Sun Yat-Sen University
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Placebo Comparator
Experimental
Experimental
Experimental
Arm Label
placebo
100mg/d resveratrol
300mg/d resveratrol
600mg/d resveratrol
Arm Description
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
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
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
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
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04886297
Brief Title
A Dose-response Study of Dietary Resveratrol on Lipid Metabolism Disorder
Official Title
Department of Nutrition and Food Hygiene,School of Public Health, Sun Yat-sen University
Study Type
Interventional
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Completed
Study Start Date
May 1, 2021 (Actual)
Primary Completion Date
May 30, 2022 (Actual)
Study Completion Date
September 30, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sun Yat-sen University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dyslipidemias
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
168 (Actual)
8. Arms, Groups, and Interventions
Arm Title
placebo
Arm Type
Placebo Comparator
Arm Description
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
Arm Title
100mg/d resveratrol
Arm Type
Experimental
Arm Description
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
Arm Title
300mg/d resveratrol
Arm Type
Experimental
Arm Description
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
Arm Title
600mg/d resveratrol
Arm Type
Experimental
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
Mega Resveratrol® capsules
Intervention Description
Subjects were orally administered Mega Resveratrol® capsules daily for 8 weeks.
Intervention Type
Drug
Intervention Name(s)
Mega Resveratrol® Placebo capsules
Intervention Description
Mega Resveratrol® Placebo capsules
Primary Outcome Measure Information:
Title
Effect of resveratrol on lipid profile in patients with dyslipidemia
Description
Lipid profile in serum will be measured, mainly including TC, TG, LDL-C and HDL-C, by automatic biochemical analyzer.
Time Frame
Change from Baseline to 4 weeks and 8 weeks
Secondary Outcome Measure Information:
Title
Effect of resveratrol on uric acid and xanthine oxidase in patients with dyslipidemia
Description
Uric acid concentration and xanthine oxidase activity will be measured by automatic biochemical analyzer and commercial kits, respectively.
Time Frame
Change from Baseline to 4 weeks and 8 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ling Wenhua
Organizational Affiliation
North Campus, Guangzhou Campus, No. 74, Zhongshan 2nd Road, Yuexiu District, Guangzhou
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sun Yat-Sen University
City
Guangzhou
State/Province
Guangdong
Country
China
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
A Dose-response Study of Dietary Resveratrol on Lipid Metabolism Disorder
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