None listed
Conditions
Brief summary
The study aims to determine if supplementation with fish oils or the vitamin coenzyme Q10, or a combination of both, will lead to beneficial effects on blood pressure and heart disease risk in patients with renal impairment. Heart disease is one of the main causes of death in Australia. People with renal impairment are at increased cardiovascular risk due to the coexistence of hypertension (high blood pressure), blood lipid abnormalities (blood fats) and increased inflammation. One approach may be to complement drug treatment of renal impairment with non-drug measures such as nutrition and lifestyle factors. In this regard, fish oils have great clinical potential in the treatment of renal impairment and its associated complications. Fish oils reduce blood pressure and improve blood vessel wall elasticity. They improve blood fats, reduce the tendency of blood to clot and reduce inflammation. Coenzyme Q10 is a vitamin that plays a critical role in cell function. It improves blood pressure, blood vessel and heart function, and glucose control.
Interventions
The study is of a factorial design. Subjects will be randomly allocated to include either fish oil (Omacor) or placebo (olive oil) capsules whilst maintaining normal dietary habits and physical activity. Within each of these groups, subjects will be further randomised to receive supplements of Coenzyme Q10 (CoQ) or placebo. The intervention will be 8 weeks. The dose of oil in both placebo and fish oil capsules will be 4 g/day. This dose of oil will have minimal contribution towards total energy
The study is of a factorial design. Subjects will be randomly allocated to include either fish oil (Omacor) or placebo (olive oil) capsules whilst maintaining normal dietary habits and physical activity. Within each of these groups, subjects will be further randomised to receive supplements of Coenzyme Q10 (CoQ) or placebo. The intervention will be 8 weeks. The dose of oil in both placebo and fish oil capsules will be 4 g/day. This dose of oil will have minimal contribution towards total energy intake. The fish oil capsules (Omacor, 1g, Solvay Pharmaceuticals, Australia) contain approximately 90% n3 fatty acids (46% EPA and 38% DHA) and 4 mg/g alpha tocopherol. This dosage provides 3.6 g per day total n3 fatty acids, which equates to about one oily fish meal per day. CoQ will be given as 100 mg twice daily (Blackmores, Australia,). Capsules will not be taken on the morning of measurements of vascular function and blood sampling in order to avoid the possibility of acute effects.
Sponsors
Dr Trevor A Mori
Study design
Allocation
Randomised controlled trial
Intervention model
Factorial
Primary purpose
Prevention
Masking
Blinded (masking used)
Eligibility
Sex/Gender
All
Age
25 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
Evidence of impaired GFR (>20 and <80 ml/min), serum creatinine <350umol/L and haemoglobin >110g/L. Patients receiving antihypertensive or lipid-lowering medication will not be excluded.
Exclusion criteria
Angina pectoris; major surgery, a cardiovascular event or diagnosis of symptoms < 3 months; BP >170/100mmHg; diabetes; liver disease; current smokers; regular non-steroidal anti-inflammatory drug therapy; eating > 1 fish meal / week or regularly taking fish oil supplements; and consuming an average > 4 standard alcoholic drinks / day.
Outcome results
None listed