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Dietary Anthocyanins Improve Glucose and Lipid Metabolism in a Dose - Dependent Manner

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ClinicalTrials.gov Identifier: NCT03415503
Recruitment Status : Not yet recruiting
First Posted : January 30, 2018
Last Update Posted : August 28, 2018
Sponsor:
Information provided by (Responsible Party):
Zhanghy, Sun Yat-sen University

Study Description
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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 Hyperglycemia 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, 160 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
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Official Title: Dietary Anthocyanins Improve Glucose and Lipid Metabolism in a Dose - Dependent Manner
Estimated Study Start Date : October 1, 2018
Estimated Primary Completion Date : May 1, 2019
Estimated Study Completion Date : December 1, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hyperglycemia

Arms and Interventions
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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 and 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: 160mg/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 consume two Medox® placebo capsules 30 min after supper.The anthocyanin capsules (80 mg anthocyanins per capsule,2 per day) will provid a total daily intake of 160 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


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Eligibility Criteria
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Ages Eligible for Study:   35 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Dyslipidemia
  • Dysglycemia
  • Must be able to swallow tablets
  • The age between 35 and 65 years old

Exclusion Criteria:

  • Insulin dependent diabetes
  • Trauma and infection
  • Drug treatment of dyslipidemia and dysglycemia
  • Pregnant woman and Breast Feeding Women
Contacts and Locations
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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


Contacts
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Contact: ZHANG H Y 15625084772 ext 86 ZHANGHY97@MAIL2.SYSU.EDU.CN

Locations
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China, Guangdong
Department of Nutrition and Food Hygiene,School of Public Health, Sun Yat-sen University Not yet recruiting
Guangzhou, Guangdong, China
Contact: ling w h, professor    87331597 ext 020    lingwh@mail.sysu.edu.cn   
Contact: zhang h y    15625084772 ext 86    zhanghy97@mail2.sysu.edu.cn   
Sponsors and Collaborators
Sun Yat-sen University
Investigators
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Principal Investigator: ZHANG H Y Department of Nutrition and Food Hygiene,School of Public Health, Sun Yat-sen University
More Information
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Responsible Party: Zhanghy, Principal Investigator, Sun Yat-sen University
ClinicalTrials.gov Identifier: NCT03415503     History of Changes
Other Study ID Numbers: lingwh87331597
First Posted: January 30, 2018    Key Record Dates
Last Update Posted: August 28, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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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
Hyperglycemia
Additional relevant MeSH terms:
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Dyslipidemias
Hyperglycemia
Lipid Metabolism Disorders
Metabolic Diseases
Glucose Metabolism Disorders