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Dietary Anthocyanins Improve Lipid Metabolism in a Dose - Dependent Manner

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ClinicalTrials.gov Identifier: NCT03415503
Recruitment Status : Completed
First Posted : January 30, 2018
Last Update Posted : November 3, 2020
Sponsor:
Information provided by (Responsible Party):
Zhanghy, Sun Yat-sen University

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.

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Study Type : Interventional  (Clinical Trial)
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 : October 1, 2018
Actual Primary Completion Date : October 1, 2019
Actual Study Completion Date : October 1, 2019

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 Name: 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 Name: 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 Name: 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 Name: Medox® Placebo capsules




Primary Outcome Measures :
  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 Outcome Measures :
  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.



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Ages Eligible for Study:   35 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03415503


Locations
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China, Guangdong
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
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Study Chair: Ling W H, Pro Department of Nutrition and Food Hygiene,School of Public Health, Sun Yat-sen University
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Zhanghy, Principal Investigator, Sun Yat-sen University
ClinicalTrials.gov Identifier: NCT03415503    
Other Study ID Numbers: lingwh87331597
First Posted: January 30, 2018    Key Record Dates
Last Update Posted: November 3, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Zhanghy, Sun Yat-sen University:
anthocyanins
dyslipidemias
dose response
Additional relevant MeSH terms:
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Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases