Dietary Anthocyanins Improve Lipid Metabolism in a Dose - Dependent Manner

Dyslipidemias Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03415503
• Other study ID #: lingwh87331597
• Status: Completed
• Phase: Phase 3
• Start date: October 1, 2018
• Est. completion date: October 1, 2019

Study information

• Verified date: October 2020
• Source: Sun Yat-sen University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 169
• Est. completion date: October 1, 2019
• Est. primary completion date: October 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 35 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Dyslipidemias

Intervention

Drug:
• Medox® Anthocyanin capsules
Subjects were orally administered Medox® capsules daily for 12 weeks.

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Sun Yat-sen University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Anthocyanin supplementation improves cholesterol efflux capacity in a dose-response manner in subjects with dyslipidemia	After 12 weeks intervention of anthocyanins,cholesterol efflux capacity (CEC) were measured at baseline, at 6 weeks, and at the end of 12 weeks.	12 weeks
Secondary	Anthocyanins supplementation improve anti-oxidative and anti-inflammation capacity in a dose-response manner in subjects with dyslipidemia.	After 12 weeks intervention of anthocyanins,Urine 8-iso-prostaglandinF2a (8-iso-PGF2a), 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-a (TNF-a) and C-reactive protein (CRP) were measured at baseline, at 6 weeks and at the end of 12 weeks.	12 weeks
Secondary	Anthocyanins supplementation attenuate platelet hyperreactivity in a dose-response manner in subjects with dyslipidemia.	After 12 weeks intervention of anthocyanins, platelet aggregation, the expression of P-selectin (CD62p) activated GP?b?a (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.	12 weeks