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

Sun Yat-sen University

Status and phase: Completed; Phase 3

Conditions: Dyslipidemias

Treatments: Drug: Mega Resveratrol® Placebo capsules; Drug: Mega Resveratrol® capsules

Study type: Interventional

Funder types: Other

Identifiers

NCT04886297

lwh87331597

Details and patient eligibility

About

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.

Full 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.

Enrollment: 168 patients

Sex: All

Ages: 35 to 70 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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168 participants in 4 patient groups, including a placebo group

placebo

Placebo Comparator group

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

Treatment:

Drug: Mega Resveratrol® Placebo capsules

100mg/d resveratrol

Experimental group

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

Treatment:

Drug: Mega Resveratrol® capsules

300mg/d resveratrol

Experimental group

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

Treatment:

Drug: Mega Resveratrol® capsules

600mg/d resveratrol

Experimental group

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

Treatment:

Drug: Mega Resveratrol® capsules