DyslipidemiasPhase 3NCT04886297
A Dose-response Study of Dietary Resveratrol on Lipid Metabolism Disorder
A Phase 3 study testing Mega Resveratrol® capsules in people with Dyslipidemias, run by Sun Yat-sen University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 35 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Dyslipidemias
- What is being tested?
- Mega Resveratrol® capsules
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 168 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2021to 30 Sep 2022
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Dyslipidemia
- The age between 35 and 70 years old
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Department of Nutrition and Food Hygiene,School of Public Health, Sun Yat-sen University
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.
Read the 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.
- Conditions
- Dyslipidemias
- Being tested
- Mega Resveratrol® capsules, Mega Resveratrol® Placebo capsules
- Medical subject headings
- Dyslipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mega Resveratrol® capsulesDrug
Subjects were orally administered Mega Resveratrol® capsules daily for 8 weeks.
Mega Resveratrol® Placebo capsulesDrug
Mega Resveratrol® Placebo capsules
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: 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 Receives: 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 Receives: Drug: Mega Resveratrol® capsules |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Uric acid concentration and xanthine oxidase activity will be measured by automatic biochemical analyzer and commercial kits, respectively.
Measured: Change from Baseline to 4 weeks and 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2021
- Study start1 May 2021
- Primary completion30 May 2022
- Study completion30 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DyslipidemiasStudies of the same condition, open and under way.
- More trials run by Sun Yat-sen UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 168 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhou Yuqing, Sun Yat-sen University
- Investigators
- Ling Wenhua, Principal investigator, North Campus, Guangzhou Campus, No. 74, Zhongshan 2nd Road, Yuexiu District, Guangzhou
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04886297
- Sponsor's protocol ID
- lwh87331597
- Status last verified
- Oct 2022
- First submitted
- 7 May 2021
- Last updated
- 27 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 36771199
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Department of Nutrition and Food Hygiene,School of Public Health, Sun Yat-sen University
- ClinicalTrials.gov ID
- NCT04886297
- Acronym / sponsor ID
- lwh87331597
- Conditions
- Dyslipidemias
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 168 participants (actual)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 1 May 2021 (actual)
- Primary completion
- 30 May 2022 (actual)
- Study completion
- 30 Sep 2022 (actual)
- First posted
- 14 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| placebo | Placebo comparator | Drug: Mega 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 resveratrol | Experimental | Drug: Mega 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 |
| 300mg/d resveratrol | Experimental | Drug: Mega 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 resveratrol | Experimental | Drug: Mega 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 |
Who may qualify
- Ages
- 35 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Dyslipidemia
- The age between 35 and 70 years old
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mega Resveratrol® capsulesSubjects were orally administered Mega Resveratrol® capsules daily for 8 weeks. | Drug | 100mg/d resveratrol, 300mg/d resveratrol, 600mg/d resveratrol |
| Mega Resveratrol® Placebo capsulesMega Resveratrol® Placebo capsules | Drug | placebo |
Primary outcome
Effect of resveratrol on lipid profile in patients with dyslipidemia
Time frame: Change 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.
1 secondary outcome
Effect of resveratrol on uric acid and xanthine oxidase in patients with dyslipidemia
Time frame: Change from Baseline to 4 weeks and 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2022.
- Derived from this study: PubMed 36771199Zhou 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ling Wenhua principal investigator
North Campus, Guangzhou Campus, No. 74, Zhongshan 2nd Road, Yuexiu District, Guangzhou
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Mega Resveratrol® capsules in people with Dyslipidemias, run by Sun Yat-sen University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effect of resveratrol on lipid profile in patients with dyslipidemia (time frame: Change from Baseline to 4 weeks and 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04886297, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2022.