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Completed

NCT Number: NCT03415503

Dietary Anthocyanins Improve Lipid Metabolism in a Dose - Dependent Manner

In order to study the effect of anthocyanins on the improvement of glucose and lipid metabolism, randomized intervention trials were conducted to compare the effects of anthocyanins on the improvement of glucose and lipid metabolism in different dose groups.To explore the best dose of anthocyanins for the prevention and treatment of anthocyanin metabolic diseases provide an important scientific basis.

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Key information

Conditions

Dyslipidemias Lipid Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

35 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Department of Nutrition and Food Hygiene,School of Public Health, Sun Yat-sen University

Guangzhou, Guangdong, China

About this study

In order to study the effect of anthocyanins on the improvement of glucose and lipid metabolism, randomized controlled trials were conducted to enrolled 300 patients with dyslipidemia. The subjects were divided into 0 mg / d, 40 mg / d, 80 mg / d, 320 mg/ d five dose groups, intervention for 12 weeks, comparing different doses of anthocyanins on glucose and lipid metabolism.To explore the best dose of anthocyanins for the prevention and treatment of anthocyanin metabolic diseases provide an important scientific basis.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Dyslipidemia
  • Subjects with dyslipidemia who also have prediabetes
  • The age between 35 and 70 years old

Exclusion criteria

  • intake of any medicine that affect lipid and glucose metabolism currently or in the preceding 6 months
  • dietary supplementation with phytochemicals including anthocyanins in the preceding 2 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

Treatment and study plan

Medox® Anthocyanin capsules

Drug

Subjects were orally administered Medox® capsules daily for 12 weeks.

Other names: Medox® Placebo capsules

Primary outcomes

  1. Anthocyanins dose-dependently improved blood lipids in patients with dyslipidemia.

    Time frame: 12 weeks

    After 12 weeks intervention of anthocyanins, serum lipid profiles were measured at baseline, at 6 weeks, and at the end of 12 weeks.

Secondary outcomes

  1. Anthocyanin supplementation improves cholesterol efflux capacity in a dose-response manner in subjects with dyslipidemia

    Time frame: 12 weeks

    After 12 weeks intervention of anthocyanins,cholesterol efflux capacity (CEC) were measured at baseline, at 6 weeks, and at the end of 12 weeks.

  2. Anthocyanins supplementation improve anti-oxidative and anti-inflammation capacity in a dose-response manner in subjects with dyslipidemia.

    Time frame: 12 weeks

    After 12 weeks intervention of anthocyanins,Urine 8-iso-prostaglandinF2α (8-iso-PGF2α), 8-hydroxy-2'-deoxyguanosine (8-OHdG) and serum malondialdehyde (MDA), superoxide dismutase (SOD), UA (urine acid), interleukin-6 (IL-6), interleukin-10(IL-10), tumor necrosis factor-α (TNF-α) and C-reactive protein (CRP) were measured at baseline, at 6 weeks and at the end of 12 weeks.

  3. Anthocyanins supplementation attenuate platelet hyperreactivity in a dose-response manner in subjects with dyslipidemia.

    Time frame: 12 weeks

    After 12 weeks intervention of anthocyanins, platelet aggregation, the expression of P-selectin (CD62p) activated GPⅡbⅢa (PAC-1), platelet reactive oxygen species (ROS) and platelet mitochondrial membrane potential (TMRM) were measured at baseline, at 6 weeks and at the end of 12 weeks.

Sponsors and collaborators

Lead sponsor

Sun Yat-sen University

Other

Registry information

Official study title

Anthocyanin Supplementation Improves Blood Lipids in a Dose-response Manner in Subjects With Dyslipidemia

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Jan 30, 2018
Registry last updated
Nov 3, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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