Back to resultsEffect of Anthocyanins on Metabolic Profiles in Subjects With Pre-diabetes
Primary Purpose
Insulin Resistance, Glucose Metabolism Disorders, Type 2 Diabetes
Status
Completed
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Anthocyanins
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Insulin Resistance
Eligibility Criteria
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.
Sites / Locations
- Baiyun Street Hospital,Yuexiu District
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Anthocyanins
Control
Arm Description
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.
A daily intake of 320mg Placebo to instead of treatment of Anthocyanins.
Outcomes
Primary Outcome Measures
Change in fasting glucose and HbA1C
Secondary Outcome Measures
The area under the curves for Glucose,insulin and C peptide releasing test(fasting and post 75g oral glucose tolerance test)
Lipids
Total cholesterol,Triglycerides,HDL cholesterol,LDL cholesterol,Apolipoprotein A-I ,Apolipoprotein B
Calculated pancreatic β-cell function and insulin resistance
Full Information
NCT ID
NCT02689765
First Posted
February 19, 2016
Last Updated
December 5, 2016
Sponsor
Sun Yat-sen University
1. Study Identification
Unique Protocol Identification Number
NCT02689765
Brief Title
Effect of Anthocyanins on Metabolic Profiles in Subjects With Pre-diabetes
Official Title
Effect of Anthocyanins on Metabolic Profiles in Subjects With Pre-diabetes: A Randomized, Double-blind, Placebo-controlled Study
Study Type
Interventional
2. Study Status
Record Verification Date
December 2016
Overall Recruitment Status
Completed
Study Start Date
February 2016 (undefined)
Primary Completion Date
October 2016 (Actual)
Study Completion Date
October 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sun Yat-sen University
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Insulin Resistance, Glucose Metabolism Disorders, Type 2 Diabetes, Lipid Metabolism Disorders
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
160 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Anthocyanins
Arm Type
Experimental
Arm Description
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.
Arm Title
Control
Arm Type
Placebo Comparator
Arm Description
A daily intake of 320mg Placebo to instead of treatment of Anthocyanins.
Intervention Type
Dietary Supplement
Intervention Name(s)
Anthocyanins
Other Intervention Name(s)
Medox
Intervention Description
Anthocyanins capsules, which comprises different natural Anthocyanins purified from bilberries and blackcurrants
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Intervention Description
Placebo capsules is identically packaged.
Primary Outcome Measure Information:
Title
Change in fasting glucose and HbA1C
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
The area under the curves for Glucose,insulin and C peptide releasing test(fasting and post 75g oral glucose tolerance test)
Time Frame
12 weeks
Title
Lipids
Description
Total cholesterol,Triglycerides,HDL cholesterol,LDL cholesterol,Apolipoprotein A-I ,Apolipoprotein B
Time Frame
12 weeks
Title
Calculated pancreatic β-cell function and insulin resistance
Time Frame
12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Baiyun Street Hospital,Yuexiu District
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510100
Country
China
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
33061500
Citation
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.
Results Reference
derived
PubMed Identifier
32973912
Citation
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.
Results Reference
derived
PubMed Identifier
32930848
Citation
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.
Results Reference
derived
Links:
URL
http://www.ncbi.nlm.nih.gov/pubmed/?term=Purified+anthocyanin+supplementation+reduces+dyslipidemia%2C+enhances+antioxidant+capacity%2C+and+prevents+insulin+resistance+in+diabetic+patients
Description
The effects of purified anthocyanins on dyslipidemia, oxidative status, and insulin sensitivity in patients with type 2 diabetes.
URL
http://www.ncbi.nlm.nih.gov/pubmed/?term=A+CONSORT-compliant%2C+randomized%2C+double-blind%2C+placebo-controlled+pilot+trial+of+purified+anthocyanin+in+patients+with+nonalcoholic+fatty+liver+disease
Description
The effects of anthocyanin supplementation on insulin resistance and liver injury biomarkers in patients with NAFLD.
URL
http://www.ncbi.nlm.nih.gov/pubmed/?term=Anti-inflammatory+effect+of+purified+dietary+anthocyanin+in+adults+with+hypercholesterolemia%3A+a+randomized+controlled+trial
Description
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
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Effect of Anthocyanins on Metabolic Profiles in Subjects With Pre-diabetes
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