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

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

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.

Study Overview

• Status: Completed
• Conditions: Glucose Metabolism Disorders; Insulin Resistance; Type 2 Diabetes; Lipid Metabolism Disorders
• Intervention / Treatment: Dietary supplement: Anthocyanins; Dietary supplement: Placebo

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 Type: Interventional
• Enrollment (Actual): 160
• Phase: Phase 4

Contacts and Locations

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510100
      • Baiyun Street Hospital,Yuexiu District

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 75 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Dietary supplement: Anthocyanins; Anthocyanins capsules, which comprises different natural Anthocyanins purified from bilberries and blackcurrants; Other Names: Medox
Placebo Comparator: Control; A daily intake of 320mg Placebo to instead of treatment of Anthocyanins.	Dietary supplement: Placebo; Placebo capsules is identically packaged.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change in fasting glucose and HbA1C	12 weeks

Secondary Outcome Measures

Outcome Measure	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	12 weeks
Calculated pancreatic β-cell function and insulin resistance		12 weeks

Collaborators and Investigators

• Sponsor: Sun Yat-sen University

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Helpful Links

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

Study record dates

Study Major Dates

• Study Start: February 1, 2016
• Primary Completion (Actual): October 1, 2016
• Study Completion (Actual): October 1, 2016

Study Registration Dates

• First Submitted: February 19, 2016
• First Submitted That Met QC Criteria: February 23, 2016
• First Posted (Estimate): February 24, 2016

Study Record Updates

• Last Update Posted (Estimate): December 6, 2016
• Last Update Submitted That Met QC Criteria: December 5, 2016
• Last Verified: December 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Endocrine System Diseases; Hyperinsulinism; Diabetes Mellitus; Disease; Prediabetic State; Insulin Resistance; Metabolic Diseases; Lipid Metabolism Disorders; Glucose Metabolism Disorders
• Other Study ID Numbers: 20151218

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED