Dietary Anthocyanins Improve Lipid Metabolism in a Dose - Dependent Manner

NCT03415503 | Completed Phase 3

• 1 other identifier: lingwh87331597
• Study Type: interventional
• Target: 169
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Dyslipidemias

Keywords

anthocyanins; dyslipidemias; dose response

Outcome Measures

Primary Outcomes (1)

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

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

  12 weeks

Secondary Outcomes (3)

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

  12 weeks

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

  12 weeks

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

  12 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 2 Medox® placebo capsules twice daily (30 min after breakfast or supper).

Drug: Medox® Anthocyanin capsules

40mg/d anthocyanins

EXPERIMENTAL

Medox® Anthocyanin capsules is consisted of 17 different natural purified anthocyanins.from bilberry (Vaccinium myrtillus) and black currant (Ribesnigrum). To achieve the double-blind,every group are instructed to consume the same amount of capsule. During the trial period, the participants will be instructed to consume one Medox® anthocyanin capsules and one Medox® placebo capsules 30 min after breakfast and consume two Medox® placebo capsules 30 min after supper.The anthocyanin capsules (40 mg anthocyanins per capsule) will provid a total daily intake of 40 mg anthocyanins.

Drug: Medox® Anthocyanin capsules

80mg/d anthocyanins

EXPERIMENTAL

Medox® Anthocyanin capsules is consisted of 17 different natural purified anthocyanins.from bilberry (Vaccinium myrtillus) and black currant (Ribesnigrum).To achieve the double-blind,every group are instructed to consume the same amount of capsule. During the trial period, the participants will be instructed to consume one Medox® anthocyanin capsules and one Medox® placebo capsules 30 min after breakfast and consume two Medox® placebo capsules 30 min after supper.The anthocyanin capsules (80 mg anthocyanins per capsule) will provid a total daily intake of 80 mg anthocyanins.

Drug: Medox® Anthocyanin capsules

320mg/d anthocyanins

EXPERIMENTAL

Medox® Anthocyanin capsules is consisted of 17 different natural purified anthocyanins.from bilberry (Vaccinium myrtillus) and black currant (Ribesnigrum).To achieve the double-blind,every group are instructed to consume the same amount of capsule. During the trial period, the participants will be instructed to consume two Medox® anthocyanin capsules 30 min after breakfast and after supper.The anthocyanin capsules (80 mg anthocyanins per capsule,4 per day) will provid a total daily intake of 320 mg anthocyanins.

Drug: Medox® Anthocyanin capsules

Interventions

Medox® Anthocyanin capsules DRUG

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

Also known as: Medox® Placebo capsules

320mg/d anthocyanins; 40mg/d anthocyanins; 80mg/d anthocyanins; placebo

Eligibility Criteria

• Age: 35 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sun Yat-sen University: lead

Study Sites (1)

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

Guangzhou, Guangdong, China

Location

Related Publications (1)

• Zhao Y, Xu H, Tian Z, Wang X, Xu L, Li K, Gao X, Fan D, Ma X, Ling W, Yang Y. Dose-dependent reductions in plasma ceramides after anthocyanin supplementation are associated with improvements in plasma lipids and cholesterol efflux capacity in dyslipidemia: A randomized controlled trial. Clin Nutr. 2021 Apr;40(4):1871-1878. doi: 10.1016/j.clnu.2020.10.014. Epub 2020 Oct 15.

  PMID: 33131908 DERIVED

MeSH Terms

Conditions

Dyslipidemias

Condition Hierarchy (Ancestors)

Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Ling W H, Pro

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

  STUDY CHAIR

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: December 12, 2017
• First Posted: January 30, 2018
• Study Start: October 1, 2018
• Primary Completion: October 1, 2019
• Study Completion: October 1, 2019
• Last Updated: November 3, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)