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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

Tracking Information
First Submitted Date  ICMJE December 12, 2017
First Posted Date  ICMJE January 30, 2018
Last Update Posted Date November 3, 2020
Actual Study Start Date  ICMJE October 1, 2018
Actual Primary Completion Date October 1, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 1, 2020)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: January 23, 2018)
Anthocyanins dose-dependently improved blood lipids in patients with dyslipidemia. [ Time Frame: 12 weeks ]
After 12 weeks intervention of anthocyanins,cholesterol in serum will be measured,mainly includeLDL-c and HDL-c. HDL-cholesterol and LDL-cholesterol concentrations were measured by using the clearance method.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 30, 2020)
  • 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.
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Dietary Anthocyanins Improve Lipid Metabolism in a Dose - Dependent Manner
Official Title  ICMJE Anthocyanin Supplementation Improves Blood Lipids in a Dose-response Manner in Subjects With Dyslipidemia
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.
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Condition  ICMJE Dyslipidemias
Intervention  ICMJE Drug: Medox® Anthocyanin capsules
Subjects were orally administered Medox® capsules daily for 12 weeks.
Other Name: Medox® Placebo capsules
Study Arms  ICMJE
  • 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).
    Intervention: Drug: Medox® Anthocyanin 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.
    Intervention: Drug: Medox® Anthocyanin 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.
    Intervention: Drug: Medox® Anthocyanin 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.
    Intervention: Drug: Medox® Anthocyanin capsules
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 1, 2020)
169
Original Estimated Enrollment  ICMJE
 (submitted: January 23, 2018)
300
Actual Study Completion Date  ICMJE October 1, 2019
Actual Primary Completion Date October 1, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 35 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03415503
Other Study ID Numbers  ICMJE lingwh87331597
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party Zhanghy, Sun Yat-sen University
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Sun Yat-sen University
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Ling W H, Pro Department of Nutrition and Food Hygiene,School of Public Health, Sun Yat-sen University
PRS Account Sun Yat-sen University
Verification Date October 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP