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

Phase 4

Completed

• Conditions: Insulin Resistance; Glucose Metabolism Disorders; Lipid Metabolism Disorders; Type 2 Diabetes
• Interventions: Dietary Supplement: Placebo; Dietary Supplement: Anthocyanins

• Registration Number: NCT02689765
• Lead Sponsor: Sun Yat-sen University

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.

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 Timeline

• Study Start: 2016-02
• Study First Submitted: 2016-02-19
• Study First Submitted QC: 2016-02-23
• Study First Posted: 2016-02-24
• Primary Completion: 2016-10
• Study Completion: 2016-10
• Status Verified: 2016-12
• Last Update Submitted: 2016-12-05
• Last Update Posted: 2016-12-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 160

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control	Placebo	A daily intake of 320mg Placebo to instead of treatment of Anthocyanins.
Anthocyanins	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.

Primary Outcome Measures

Name	Time	Method
Change in fasting glucose and HbA1C	12 weeks

Secondary Outcome Measures

Name	Time	Method
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
The area under the curves for Glucose,insulin and C peptide releasing test(fasting and post 75g oral glucose tolerance test)	12 weeks

Trial Locations

Locations (1)

Baiyun Street Hospital,Yuexiu District; 🇨🇳 Guangzhou, Guangdong, China