NCT04886297

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
168

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started May 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2021

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

May 7, 2021

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 14, 2021

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2022

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2022

Completed
Last Updated

October 27, 2022

Status Verified

October 1, 2022

Enrollment Period

1.1 years

First QC Date

May 7, 2021

Last Update Submit

October 24, 2022

Conditions

Dyslipidemias

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Effect of resveratrol on uric acid and xanthine oxidase in patients with dyslipidemia

    Change from Baseline to 4 weeks and 8 weeks

Study Arms (4)

placebo

PLACEBO COMPARATOR

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

100mg/d resveratrol

EXPERIMENTAL

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

300mg/d resveratrol

EXPERIMENTAL

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

600mg/d resveratrol

EXPERIMENTAL

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

Interventions

Mega Resveratrol® capsulesDRUG

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

100mg/d resveratrol300mg/d resveratrol600mg/d resveratrol
Mega Resveratrol® Placebo capsulesDRUG

Mega Resveratrol® Placebo capsules

placebo

Eligibility Criteria

Age35 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Dyslipidemia
  • The age between 35 and 70 years old

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sun Yat-Sen University

Guangzhou, Guangdong, China

Location

Related Publications (1)

  • 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.

    PMID: 36771199DERIVED

MeSH Terms

Conditions

Dyslipidemias

Condition Hierarchy (Ancestors)

Lipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Ling Wenhua

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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

May 7, 2021

First Posted

May 14, 2021

Study Start

May 1, 2021

Primary Completion

May 30, 2022

Study Completion

September 30, 2022

Last Updated

October 27, 2022

Record last verified: 2022-10

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)