Investgation of the effect of Curcumin and/or omega-3 polyunsaturated fatty acids supplementation on anthropometric indices, glucose hemostasis, markers of cardiometabolic risk and gene expression of vascular endothelial growth factor and serum concentrations of inflammatory and oxidatve stress indices in type 2 diabetic patients
Determining of the effect of Curcumin and/or omega-3 polyunsaturated fatty acids supplementation on anthropometric indices, glucose hemostasis, markers of cardiometabolic risk and gene expression of vascular endothelial growth factor and serum concentrations of inflammatory and oxidatve stress indices in type 2 diabetic patients
Design
A triple blinded randomized controlled clinical trial with parallel groups
Settings and conduct
This study will be a randomized, triple-blind clinical trial in type 2 diabetes patients in Emam Reza hospital in Tabriz. Participants will be recruited through a convenience sampling and randomly divided into four groups matched based on body mass index, dosage and type of drug. Similar envelopes will be used to conceal the allocation in opaque numbered packages.
Participants/Inclusion and exclusion criteria
Inclusion criteria: > 18 years old, diagnosed as having T2DM based on the criterion of the American Diabetes Association, at least moderately controlled diabetes (%5/8>HbA1c) and a stable anti-diabetic drug regimen (over 4 months) before starting the study
Exclusion criteria: Omega 3 fatty acids supplement intake, multivitamin-mineral supplements or medicinal products that interfere with patients' lipid profile, cancer and any chronic disease other than diabetes, pregnancy and lactation
Intervention groups
Intervention group 1: Two 1000 mg omega-3 capsules daily and two 500 mg turmeric capsules for 12 weeks.
Intervention group 2: Two 500 mg turmeric capsules and two placebo capsules of Omega 3 containing sunflower oil
Intervention group 3: Two 1000 mg omega-3 capsules and 2 capsules of turmeric placebo
Intervention group 4 (control): two placebo omega-3 capsules and 2 capsules of turmeric placebo
Investgation of the effect of Curcumin and/or omega-3 polyunsaturated fatty acids supplementation on anthropometric indices, glucose hemostasis, markers of cardiometabolic risk and gene expression of vascular endothelial growth factor and serum concentrations of inflammatory and oxidatve stress indices in type 2 diabetic patients
Public title
Curcumin and/or omega-3 polyunsaturated fatty acids supplementation in diabetes mellitus
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
> 18 years old
Diagnosed as having T2DM based on the criterion of the American Diabetes Association
At least moderately controlled diabetes (%5/8>HbA1c)
A stable anti-diabetic drug regimen (over 4 months) before starting the study
Exclusion criteria:
Omega 3 fatty acids supplement intake
Multivitamin-mineral supplements or medicinal products that interfere with patients' lipid profile
Cancer and any chronic disease other than diabetes
Pregnancy and lactation
Smoking
Drinking
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Data and Safety Monitoring Board
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
A block randomization method will be used to allocate participants to the groups with a 1:1:1:1 allocation using random allocation software (RAS) with block sizes of 4 and 8. Similar sealed envelopes will be used to conceal the allocation in a sequentially numbered opaque package.
Blinding (investigator's opinion)
Triple blinded
Blinding description
The clinical trial will be triple-blinded and study participants and the trial team/researchers conducting the intervention and assessing the outcomes will be blinded
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tabriz University of Medical Sciences
Street address
Research Vice Chancellor, Tabriz University of Medical Sciences, Daneshgah Ave.
City
تبریز
Province
East Azarbaijan
Postal code
3658745698
Approval date
2019-10-24, 1398/08/02
Ethics committee reference number
IR.TBZMED.REC.1398.759
Health conditions studied
1
Description of health condition studied
Type 2 diabetes mellitus
ICD-10 code
E11
ICD-10 code description
Type 2 diabetes mellitus
Primary outcomes
1
Description
Anthropometric indices
Timepoint
Measurement of body weight at baseline (before intervention) and 6 and 12 weeks after omega-3 and / or turmeric supplementation
Method of measurement
Seca digital scale
2
Description
Glucose homeostasis (fasting glucose and insulin concentration)
Timepoint
Measurement of glucose homeostasis at baseline (before intervention) and 12 weeks after omega-3 and / or turmeric supplementation
Method of measurement
Biochemical analysis
3
Description
Cardiometabolic risk markers (triglycerides, total cholesterol, LDL cholesterol, HDL cholesterol and VLDL cholesterol)
Timepoint
Measurement of cardiometabolic risk markers at baseline (before intervention) and 12 weeks after omega-3 and / or turmeric supplementation
Method of measurement
Biochemical analysis
4
Description
Gene expression of vascular endothelial growth factor
Timepoint
Measurement of Gene expression of vascular endothelial growth factor at baseline (before intervention) and 12 weeks after omega-3 and / or turmeric supplementation
Method of measurement
Biochemical analysis
Secondary outcomes
1
Description
Serum concentration of inflammatory indices (hs-CRP)
Timepoint
Measurement the serum levels of inflammatory markers at baseline (before intervention) and 12 weeks after omega-3 and / or turmeric supplementation
Method of measurement
Biochemical analysis
2
Description
Serum concentration of oxidative stress indices (MDA and TAC)
Timepoint
Measurement the serum levels of oxidative stress indices at baseline (before intervention) and 12 weeks after omega-3 and / or turmeric supplementation
Method of measurement
Biochemical analysis
Intervention groups
1
Description
Intervention group 1: Daily intake of two 1000 mg omega-3 capsules (Zahravi pharma co.) and two 500 mg turmeric capsules (made by Dineh Company) for 12 weeks after meals
Category
Treatment - Other
2
Description
Intervention group 2: Daily intake of two 500 mg turmeric capsules (made by Dineh Company) and two omega-3 placebo capsules containing sunflower oil and for 12 weeks after meals
Category
Treatment - Other
3
Description
Intervention group 3: Daily intake of two 1000 mg omega-3 capsules (Zahravi pharma co.) and two turmeric placebop capsules for 12 weeks after meals
Category
Treatment - Other
4
Description
Control group: Daily intake of two turmeric placebo capsules and two omega-3 placebo capsules containing sunflower oil and for 12 weeks after meals