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Effect of Anthocyanins on Metabolic Profiles in Subjects With Pre-diabetes

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ClinicalTrials.gov Identifier: NCT02689765
Recruitment Status : Completed
First Posted : February 24, 2016
Last Update Posted : December 6, 2016
Sponsor:
Information provided by (Responsible Party):
LiPing Yang, Sun Yat-sen University

Study Description
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Brief Summary:
Metabolic problems represent one of the major health concerns which are attractive for being addressed by nutritional interventions, as these are directly connected to dietary habits.Anthocyans possess cardiovascular disease prevention, obesity control, and diabetes alleviation properties, but association between anthocyans and prediabetes need to be more firmly understood and established from robust clinical data. However, there is little human research that has reported on the efficacy of increased anthocyans bioactive consumption on insulin sensitivity in pre-diabetes.

Condition or disease Intervention/treatment Phase
Insulin Resistance Glucose Metabolism Disorders Type 2 Diabetes Lipid Metabolism Disorders Dietary Supplement: Anthocyanins Dietary Supplement: Placebo Phase 4

Detailed Description:
The investigators plan to conduct a randomized double-blind, placebo-controlled trial to characterize the potential effects of anthocyans, purified from bilberries and blackcurrants, on metabolic abnormalities commonly associated with type 2 pre-diabetes.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 160 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effect of Anthocyanins on Metabolic Profiles in Subjects With Pre-diabetes: A Randomized, Double-blind, Placebo-controlled Study
Study Start Date : February 2016
Actual Primary Completion Date : October 2016
Actual Study Completion Date : October 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prediabetes

Arms and Interventions
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Arm Intervention/treatment
Experimental: Anthocyanins
Volunteers will be randomised double blinded into 'Anthocyanins' groups(n=60 per group)and given twice daily two capsules of either 80 grams of Anthocyanins, which corresponds a mixture of fresh blue berries and blackcurrants.The total duration of this trial was 24wk.
 Dietary Supplement: Anthocyanins
Anthocyanins capsules, which comprises different natural Anthocyanins purified from bilberries and blackcurrants
Other Name: Medox
Placebo Comparator: Control
A daily intake of 320mg Placebo to instead of treatment of Anthocyanins.
 Dietary Supplement: Placebo
Placebo capsules is identically packaged.


Outcome Measures
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Primary Outcome Measures :
  1. Change in fasting glucose and HbA1C [ Time Frame: 12 weeks ]

Secondary Outcome Measures :
  1. The area under the curves for Glucose,insulin and C peptide releasing test(fasting and post 75g oral glucose tolerance test) [ Time Frame: 12 weeks ]
  2. Lipids [ Time Frame: 12 weeks ]
    Total cholesterol,Triglycerides,HDL cholesterol,LDL cholesterol,Apolipoprotein A-I ,Apolipoprotein B

  3. Calculated pancreatic β-cell function and insulin resistance [ Time Frame: 12 weeks ]

Eligibility Criteria
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Ages Eligible for Study:   40 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • FPG 100 mg/dL (5.6 mmol/L) to 125 mg/dL (6.9 mmol/L) (IFG) OR 2-h plasma glucose in the 75gOGTT 140 mg/dL (7.8 mmol/L) to 199 mg/dL (11.0 mmol/L)(IGT) OR HbA1C 5.7-6.4%.
  • Newly diagnosed T2DM who exceed the upper limit of the range but has not yet accepted hypoglycemic therapy.

Exclusion Criteria:

Patients with cardiac, renal, or hepatic diseases or with hyperthyroidism or who had concomitant infections, or who use of anti-diabetic drug or potential affect plasma glucose drugs, pregnant and breast-feeding women, and with polycystic ovarian syndrome.

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): NCT02689765


Locations
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China, Guangdong
Baiyun Street Hospital,Yuexiu District
Guangzhou, Guangdong, China, 510100
Sponsors and Collaborators
Sun Yat-sen University
More Information
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Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: LiPing Yang, PhD, Sun Yat-sen University
ClinicalTrials.gov Identifier: NCT02689765    
Other Study ID Numbers: 20151218
First Posted: February 24, 2016    Key Record Dates
Last Update Posted: December 6, 2016
Last Verified: December 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Additional relevant MeSH terms:
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Diabetes Mellitus
Insulin Resistance
Prediabetic State
Metabolic Diseases
Glucose Metabolism Disorders
 Lipid Metabolism Disorders
Disease
Pathologic Processes
Endocrine System Diseases
Hyperinsulinism