None listed
Conditions
Brief summary
The prevalence of type 2 diabetes (T2D) and its associated complications represents a major global health hazard. According to the Diabetes Australia, the number of individuals with T2D reached 1.7 million with 1.2 million diagnosed and registered cases. Individuals with T2D are associated with two-four fold increased the risk of cardiovascular diseases (CVD) such as stroke, peripheral vascular disease, myocardial infarction and angina pectoris. CVD accounts for more than 70% of deaths in patients with T2D. Epidemiological studies documented T2D as an independent risk factor for CVD in both men and women. Despite effective glucose control measures and advances in the management of CVD in T2D, several other chronic risk factors like high blood pressure, abnormal triglycerides, small dense LDL particles, low HDL-C and insulin resistance increase the risk of developing CVD in individuals with type 2 diabetes. T2D related changes in the plasma lipid levels are key factors among the other factors that are manageable by interventions to control the CVD risk. It is well documented that combination of high plasma triglyceride levels and low HDL-C (HDL-C2) is well associated with cardiovascular risk. The previous meta-analysis has reported that every 1mmol/L increase in triglyceride increase cardiovascular disease risk by 32% in men and 76% increase in women. Along with the triglycerides, the glycosylation and oxidation of LDL particles differ in type 2 diabetes when compared with non-diabetic individuals. Several randomized controlled trials have supported the association of the reduction of LDL-C (up to 1mmol/L) with reduced cardiovascular disease. Targeting blood lipids and inflammation in type 2 diabetes individuals who are at a high risk of developing CVD will help to resolute these modifiable risk factors and presumably reduce the overall risk of developing CVD. In the present study, we propose to evaluate the complementary and/or synergistic effects of curcumin and n-3PUFA in modulating lipid profiles (decrease in triglycerides and small dense LDL-C particles) in individuals with type 2 diabetes through a 6 weeks factorial randomised controlled trial . We also evaluate the effects of curcumin and LCn-3PUFA on secondary outcomes such as inflammation, blood glucose, and blood pressure.
Interventions
Study participants will be randomly allocated to these treatment arms for 6 weeks
1) 2 X placebo tablets (matching for curcumin) + 2 X placebo capsules (matching for fish oil) per day
2) 2 X 500 mg curcumin tablets + 2 X placebo capsules (matching for fish oil) per day
3) 2 X 1000 mg fish oil capsules + 2 X placebo tablets (matching for curcumin) per day
4) 2 X 500 mg curcumin tablets + 2 X 1000 mg fish oil capsules per day
To monitor adherence to intervention,
1. Capsule intake by participa
Study participants will be randomly allocated to these treatment arms for 6 weeks 1) 2 X placebo tablets (matching for curcumin) + 2 X placebo capsules (matching for fish oil) per day 2) 2 X 500 mg curcumin tablets + 2 X placebo capsules (matching for fish oil) per day 3) 2 X 1000 mg fish oil capsules + 2 X placebo tablets (matching for curcumin) per day 4) 2 X 500 mg curcumin tablets + 2 X 1000 mg fish oil capsules per day To monitor adherence to intervention, 1. Capsule intake by participants will be measured on post-intervention visit 2. Compliance to the omega 3 fatty acids will be monitored by measuring participant's erythrocyte fatty acid content 3. Adherence to curcumin will be monitored by measuring curcumin content in the participant blood sample by using HPLC method.
Sponsors
The University of Newcastle
Study design
Allocation
Randomised controlled trial
Intervention model
Factorial
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver)
Eligibility
Sex/Gender
All
Age
40 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
This study is suitable for you if You are aged between 40 and 75 years; You are diagnosed with type 2 diabetes (duration less than 15 years) Your body mass index (BMI) lies between 25 and 45 kg/m2
Exclusion criteria
This study is not suitable for you if: You are pregnant, planning to become pregnant or breastfeeding Cannot provide informed consent You have type 1 diabetes You are currently on insulin treatment You are diagnosed with cancer You have a glomerular filtration rate less than 45 You have been diagnosed with painful peripheral neuropathy You have a cardiac pacemaker You have a history of severe neurological diseases (Parkinson’s, multiple sclerosis, epilepsy) You are consuming more than 2 serves of oily fish per week You are taking regular dietary supplements known to influence blood lipid levels You have sensitivity/ intolerance to the products involved in this study You are unwilling to fast for 10 hours before giving blood sample
Outcome results
None listed