Effect of Anthocyanins on Metabolic Profiles in Subjects With Pre-diabetes
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02689765|
Recruitment Status : Completed
First Posted : February 24, 2016
Last Update Posted : December 6, 2016
|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|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||160 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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|
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.
- Change in fasting glucose and HbA1C [ Time Frame: 12 weeks ]
- 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 ]
- Lipids [ Time Frame: 12 weeks ]Total cholesterol,Triglycerides,HDL cholesterol,LDL cholesterol,Apolipoprotein A-I ,Apolipoprotein B
- Calculated pancreatic β-cell function and insulin resistance [ Time Frame: 12 weeks ]
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
|Baiyun Street Hospital,Yuexiu District|
|Guangzhou, Guangdong, China, 510100|