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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Anthocyanins | Experimental | 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. |
|
| Control | Placebo Comparator | A daily intake of 320mg Placebo to instead of treatment of Anthocyanins. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Anthocyanins | Dietary Supplement | Anthocyanins capsules, which comprises different natural Anthocyanins purified from bilberries and blackcurrants |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in fasting glucose and HbA1C | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| The area under the curves for Glucose,insulin and C peptide releasing test(fasting and post 75g oral glucose tolerance test) | 12 weeks | |
| Lipids | Total cholesterol,Triglycerides,HDL cholesterol,LDL cholesterol,Apolipoprotein A-I ,Apolipoprotein B |
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Inclusion Criteria:
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.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Baiyun Street Hospital,Yuexiu District | Guangzhou | Guangdong | 510100 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33061500 | Derived | Yang L, Liu Z, Ling W, Wang L, Wang C, Ma J, Peng X, Chen J. Effect of Anthocyanins Supplementation on Serum IGFBP-4 Fragments and Glycemic Control in Patients with Fasting Hyperglycemia: A Randomized Controlled Trial. Diabetes Metab Syndr Obes. 2020 Sep 28;13:3395-3404. doi: 10.2147/DMSO.S266751. eCollection 2020. | |
| 32973912 | Derived |
| Label | URL |
|---|---|
| The effects of purified anthocyanins on dyslipidemia, oxidative status, and insulin sensitivity in patients with type 2 diabetes. | View source |
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| ID | Term |
|---|---|
| D007333 | Insulin Resistance |
| D044882 | Glucose Metabolism Disorders |
| D003924 | Diabetes Mellitus, Type 2 |
| D052439 | Lipid Metabolism Disorders |
| ID | Term |
|---|---|
| D006946 | Hyperinsulinism |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D003920 | Diabetes Mellitus |
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| ID | Term |
|---|---|
| D000872 | Anthocyanins |
| ID | Term |
|---|---|
| D005419 | Flavonoids |
| D002867 | Chromones |
| D001578 | Benzopyrans |
| D011714 | Pyrans |
| D006573 |
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| Placebo | Dietary Supplement | Placebo capsules is identically packaged. |
|
| 12 weeks |
| Calculated pancreatic β-cell function and insulin resistance | 12 weeks |
| Yang L, Ling W, Qiu Y, Liu Y, Wang L, Yang J, Wang C, Ma J. Anthocyanins increase serum adiponectin in newly diagnosed diabetes but not in prediabetes: a randomized controlled trial. Nutr Metab (Lond). 2020 Sep 21;17:78. doi: 10.1186/s12986-020-00498-0. eCollection 2020. |
| 32930848 | Derived | Yang L, Qiu Y, Ling W, Liu Z, Yang L, Wang C, Peng X, Wang L, Chen J. Anthocyanins regulate serum adipsin and visfatin in patients with prediabetes or newly diagnosed diabetes: a randomized controlled trial. Eur J Nutr. 2021 Jun;60(4):1935-1944. doi: 10.1007/s00394-020-02379-x. Epub 2020 Sep 15. |
| The effects of anthocyanin supplementation on insulin resistance and liver injury biomarkers in patients with NAFLD. | View source |
| The supplementation of an anthocyanin mixture to hypercholesterolemic subjects for 24 weeks reduced serum levels of CRP, VCAM-1 and IL-1b, which involved the improvement of the lipid profile | View source |
| D004700 | Endocrine System Diseases |
| Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006027 | Glycosides |
| D002241 | Carbohydrates |
| D010860 | Pigments, Biological |
| D001685 | Biological Factors |