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

NCT02689765 — Phase 4, Completed, 160 participants, Sun Yat-sen University

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Effect of Anthocyanins on Metabolic Profiles in Subjects With Pre-diabetes: A Randomized, Double-blind, Placebo-controlled Study

Registry	NCT02689765
Status	Completed
Phase	Phase 4
Study type	Interventional; randomized, parallel, masking: quadruple, treatment
Enrollment	160 (Actual)
Sponsor	Sun Yat-sen University (Other)
Conditions	Insulin Resistance, Glucose Metabolism Disorders, Type 2 Diabetes, Lipid Metabolism Disorders
Interventions	Anthocyanins, Placebo (Dietary supplement)
Dates	start 2016-02-01, primary completion 2016-10-01, completion 2016-10-01, first posted 2016-02-24, last updated 2016-12-06
Locations	1 site in China

-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.

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+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.

+Arms and interventions

Arm	Type	Interventions	Description
Anthocyanins	Experimental	Dietary Supplement: 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.
Control	Placebo comparator	Dietary Supplement: Placebo	A daily intake of 320mg Placebo to instead of treatment of Anthocyanins.

Anthocyanins (Dietary supplement), also known as Medox: Anthocyanins capsules, which comprises different natural Anthocyanins purified from bilberries and blackcurrants
Placebo (Dietary supplement): Placebo capsules is identically packaged.

+Outcome measures

Primary outcomes

Change in fasting glucose and HbA1C [12 weeks]

Secondary outcomes

The area under the curves for Glucose,insulin and C peptide releasing test(fasting and post 75g oral glucose tolerance test) [12 weeks]
Lipids [12 weeks]: Total cholesterol,Triglycerides,HDL cholesterol,LDL cholesterol,Apolipoprotein A-I ,Apolipoprotein B
Calculated pancreatic β-cell function and insulin resistance [12 weeks]

+Eligibility

Sex: All, ages: 40 Years to 75 Years

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.

+Locations (1)

Facility	City	Country	Status
Baiyun Street Hospital,Yuexiu District	Guangzhou, Guangdong	China

+Publications

Results publication: 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. PMID 33061500
Results publication: 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. PMID 32973912
Results publication: 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. PMID 32930848