Dietary Anthocyanins Improve Lipid Metabolism in a Dose - Dependent Manner

Sponsor

Sun Yat-sen University (Other)

Overall Status

Completed

CT.gov ID

NCT03415503

Collaborator

(none)

169

Enrollment

Location

Arms

Actual Duration (Months)

14.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Dyslipidemias	Drug: Medox® Anthocyanin capsules	Phase 3

Detailed Description

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

169 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Prevention

Official Title:

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

Actual Study Start Date :

Oct 1, 2018

Actual Primary Completion Date :

Oct 1, 2019

Actual Study Completion Date :

Oct 1, 2019

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: placebo 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 Subjects were orally administered Medox® capsules daily for 12 weeks. Other Names: Medox® Placebo capsules
Experimental: 40mg/d anthocyanins 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 Subjects were orally administered Medox® capsules daily for 12 weeks. Other Names: Medox® Placebo capsules
Experimental: 80mg/d anthocyanins 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 Subjects were orally administered Medox® capsules daily for 12 weeks. Other Names: Medox® Placebo capsules
Experimental: 320mg/d anthocyanins 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 Subjects were orally administered Medox® capsules daily for 12 weeks. Other Names: Medox® Placebo capsules

Outcome Measures

Primary Outcome Measures

Anthocyanins dose-dependently improved blood lipids in patients with dyslipidemia. [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 Outcome Measures

Anthocyanin supplementation improves cholesterol efflux capacity in a dose-response manner in subjects with dyslipidemia [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.
Anthocyanins supplementation improve anti-oxidative and anti-inflammation capacity in a dose-response manner in subjects with dyslipidemia. [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.
Anthocyanins supplementation attenuate platelet hyperreactivity in a dose-response manner in subjects with dyslipidemia. [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

35 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Department of Nutrition and Food Hygiene,School of Public Health, Sun Yat-sen University	Guangzhou	Guangdong	China

Sponsors and Collaborators

Sun Yat-sen University

Investigators

Study Chair: Ling W H, Pro, Department of Nutrition and Food Hygiene,School of Public Health, Sun Yat-sen University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Zhanghy, Principal Investigator, Sun Yat-sen University

ClinicalTrials.gov Identifier:

NCT03415503

Other Study ID Numbers:

lingwh87331597

First Posted:

Jan 30, 2018

Last Update Posted:

Nov 3, 2020

Last Verified:

Oct 1, 2020

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Keywords provided by Zhanghy, Principal Investigator, Sun Yat-sen University

anthocyanins

dyslipidemias

dose response

Additional relevant MeSH terms:

Dyslipidemias

Study Results

No Results Posted as of Nov 3, 2020