Nutritional Supplements for prevention of type 2 diabetes
Combined effects of Curcumin and Omega 3 fatty acids on plasma glucose, lipid levels and inflammation bio-markers in the individuals with pre-diabetes.
University of Newcastle
80 participants
Jul 27, 2015
Interventional
Conditions
Summary
Diabetes is a chronic non-communicable and slowly progressing metabolic disease often involving multiple pathological mechanisms. Multiple mechanisms underlie the pathogenesis of diabetes including subclinical inflammation, glucotoxicity and lipotoxicity. Elevated levels of inflammation, particularly in the adipose tissue, is believed to be the primary trigger preceded by all of the above mentioned pathological mechanisms. Recent scientific literature established a strong link between inflammation and diabetes highlighting the role of inflammation as a primary pathological trigger for development of diabetes and its complications. Current therapies in the diabetes are unidimensional, targeted only to ameliorate the hyperglycaemic conditions. To date little or no attention has been paid to design pharmaceutical strategies to delay or modulate inflammatory pathways involved in reducing insulin secretion and/or action. Moreover current anti-diabetic medications have persistent side effects, such as body weight gain and hypoglycaemia in patients on sulphonylureas and insulin; gastrointestinal problems with metformin and acarbose; weight gain and bone fractures with thiazolidinediones; genital or urinary tract infections predominantly in females with sodium glucose co-transporter inhibitors. In the light of increasing prevalence and health costs associated with diabetes and its complications, there is a necessity for development of easy to comply strategies to modulate multiple metabolic targets with excellent long-term safety profile. In search of these agents, some bioactive compounds (nutraceuticals) aiming at prevention of diabetes through anti-inflammatory mechanisms have shown promising results. Extensive research has been carried out on anti-inflammatory and anti-hyperglycaemic potential of curcumin. Also the long chain n-3PUFA have been shown to possess lipid-lowering and anti-inflammatory properties by modulating multiple metabolic targets. We propose to evaluate the complimentary and/or synergistic effects of curcumin and/or n-3PUFA on pro-inflammatory mediators and insulin sensitivity in people with pre-diabetes. This is a 2x2 factorial, randomized, double blind, placebo controlled study. Eligible participants will be asked to consume 4 caps daily; placebo, curucmin plus placebo, omega 3 fatty acids plus placebo, curucmin and omega 3 fatty acids combination, for 12 weeks. Participants will be donating blood on the first day and post intervention along with information on 3 day food consumption, physical activity and other medications.
Eligibility
Inclusion Criteria9
- Age – 30-70; gender – both males and females
- No participation in any clinical trial for at least 3 months
- An HbA1c of 5.7% - 6.4%
- Impaired Glucose Tolerance (IGT):
- -hour OGTT plasma glucose greater than or equal to 7.8 mmol/ Land <11.1 mmol/L
- Impaired fasting glucose (IFG):
- Fasting plasma venous glucose measurement 6.1–6.9 mmol/L
- or more score or High risk individuals in AUSDRISK assessment tool
- BMI between 25-45
Exclusion Criteria14
- Pregnancy or lactation
- Established type 2 diabetes
- Allergic to sea foods
- People with gall bladder problems
- People currently on medication with erythropoietin
- People with anaemia
- People with pace maker implants
- Currently on medication with Aspirin and Warfarin
- History of severe neurological diseases or seizures
- History of new investigational drug three months prior to this trial
- Consuming more than 2 serve of oily fish per week
- Taking regular dietary supplements known to influence blood glucose level
- People taking regular vitamin C supplements
- Unwilling to fast for 10hr before obtaining blood samplePeople currently on medication with clopidogrel, ibuprofen, naproxen, dalteparin, enoxaparin and heparin,
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Interventions
Study participants will be randomly allocated to these treatment arms for 3 months Arm 1 : Placebo: 4 capsules/day (2 each for curcumin and fish oil placebos) Arm 2 : Curcumin (2 Tab @500 mg each) providing 180 mg curcumin plus 2 placebo capsules/day Arm 3: n-3PUFA (2 cap @1000mg each) providing 1.2g EPA/DHA plus 2 placebo capsules/day Arm 4: Curcumin (2 Tab @500 mg each providing a total of 180 mg curcumin) and n-3PUFA (2 cap @1000mg each providing a total of 1.2g EPA/DHA) per day To monitor adherence to intervention, 1. Capsule intake by participants will be measured on 6th and 12th week 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 curucmin content in the participant blood sample by using HPLC method.
Locations(1)
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ACTRN12615000559516