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

Type 2 Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02689765
• Other study ID #: 20151218
• Status: Completed
• Phase: Phase 4
• First received: February 19, 2016
• Last updated: December 5, 2016
• Start date: February 2016
• Est. completion date: October 2016

Study information

• Verified date: December 2016
• Source: Sun Yat-sen University
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 160
• Est. completion date: October 2016
• Est. primary completion date: October 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 75 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus
• Disease
• Glucose Intolerance
• Glucose Metabolism Disorders
• Insulin Resistance
• Lipid Metabolism Disorders
• Metabolic Diseases
• Prediabetic State
• Type 2 Diabetes

Intervention

Dietary Supplement:
• Anthocyanins
Anthocyanins capsules, which comprises different natural Anthocyanins purified from bilberries and blackcurrants
• Placebo
Placebo capsules is identically packaged.

Locations

Country	Name	City	State
China	Baiyun Street Hospital,Yuexiu District	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Sun Yat-sen University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in fasting glucose and HbA1C		12 weeks	Yes
Secondary	The area under the curves for Glucose,insulin and C peptide releasing test(fasting and post 75g oral glucose tolerance test)		12 weeks	Yes
Secondary	Lipids	Total cholesterol,Triglycerides,HDL cholesterol,LDL cholesterol,Apolipoprotein A-I ,Apolipoprotein B	12 weeks	Yes
Secondary	Calculated pancreatic ß-cell function and insulin resistance		12 weeks	Yes

External Links

•   The effects of anthocyanin supplementation on insulin resistance and liver injury biomarkers in patients with NAFLD.
•   The effects of purified anthocyanins on dyslipidemia, oxidative status, and insulin sensitivity in patients with type 2 diabetes.
•   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