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

NCT ID: NCT04886297

Last Updated: 2022-10-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

168 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-05-01

Study Completion Date

2022-09-30

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.

Conditions

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Dyslipidemias

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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placebo

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

Group Type PLACEBO_COMPARATOR

Mega Resveratrol® Placebo capsules

Intervention Type DRUG

Mega Resveratrol® Placebo capsules

100mg/d resveratrol

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

Group Type EXPERIMENTAL

Mega Resveratrol® capsules

Intervention Type DRUG

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

300mg/d resveratrol

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

Group Type EXPERIMENTAL

Mega Resveratrol® capsules

Intervention Type DRUG

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

600mg/d resveratrol

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

Group Type EXPERIMENTAL

Mega Resveratrol® capsules

Intervention Type DRUG

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

Interventions

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Mega Resveratrol® capsules

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

Intervention Type DRUG

Mega Resveratrol® Placebo capsules

Mega Resveratrol® Placebo capsules

Intervention Type DRUG

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
Minimum Eligible Age

35 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Sun Yat-sen University

OTHER

Sponsor Role lead

Responsible Party

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Zhou Yuqing

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ling Wenhua

Role: PRINCIPAL_INVESTIGATOR

North Campus, Guangzhou Campus, No. 74, Zhongshan 2nd Road, Yuexiu District, Guangzhou

Locations

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Sun Yat-Sen University

Guangzhou, Guangdong, China

Site Status

Countries

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China

References

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Zhou Y, Zeng Y, Pan Z, Jin Y, Li Q, Pang J, Wang X, Chen Y, Yang Y, Ling W. A Randomized Trial on Resveratrol Supplement Affecting Lipid Profile and Other Metabolic Markers in Subjects with Dyslipidemia. Nutrients. 2023 Jan 17;15(3):492. doi: 10.3390/nu15030492.

Reference Type DERIVED
PMID: 36771199 (View on PubMed)

Other Identifiers

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lwh87331597

Identifier Type: -

Identifier Source: org_study_id

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