Investigation of the Effects of Omega-3 Supplementation in Chronic Kidney Disease Patients Diagnosed With Coronary Artery Disease and Dyslipidemia

Condition(s) studied

Investigational drug(s) / intervention(s)

Omega-3 Suplementation: The intervention group will receive a daily oral supplementation of 2000 mg omega-3, which will not be administered to the control group. Blood samples will be collected from all participants at baseline and at the end of the study to evaluate selected serum parameters. To minimize nutritional variability, individualized diets appropriate for coronary artery disease and chronic kidney disease were prescribed to both groups at the beginning of the study. Unlike many other intervention studies, this trial specifically targets end-stage renal disease patients and includes an evaluation of the intervention's impact in relation to dialysis initiation.

No intervention: Participants in the control group will not receive any dietary supplementation. Blood samples will be collected at baseline and at the end of the study to assess selected biochemical parameters. Standard dietary care appropriate for coronary artery disease and chronic kidney disease will be maintained throughout the study.

Study summary

Chronic kidney disease (CKD) is characterized by the slow, progressive, and irreversible loss of kidney function. Uremic toxins in CKD patients trigger an inflammatory response driven by various cytokines, chemokines, and other inflammatory molecules. As a result, increased oxidative stress and tissue damage are observed. In such an inflammatory environment, CKD patients are at higher risk of mortality due to the occurrence of adverse cardiovascular events. Omega-3 fatty acids are long-chain polyunsaturated fatty acids such as α-linolenic acid (ALA, 18:3), eicosapentaenoic acid (EPA, 20:5), and docosahexaenoic acid (DHA, 22:6). Omega-3 fatty acids are essential fatty acids because they cannot be synthesized in the body. There is increasing evidence that omega-3 fatty acids play a role in regulating inflammation and immune response by reducing the production of monocyte proinflammatory cytokines interleukin-1 (IL-1), IL-6, and TNF-α. Omega-3 has also been shown to alter abnormal lipid metabolism, reduce platelet aggregation, improve homocysteine levels, and improve endothelial function, blood pressure, heart rate, and oxidative stress.

This study, which aims to observe the effectiveness of omega-3 supplementation in individuals who must have a diet low in omega-3 fatty acids due to certain dietary restrictions (especially fish), will be conducted at the Health Sciences University Dr. Siyami Ersek Thoracic and Cardiovascular Surgery Education Research Hospital. 60 patients between the ages of 50-75 with chronic kidney disease diagnosed with coronary artery disease and dyslipidemia will be included in the study. The study will include patients with stage 2-4 chronic kidney disease who have a history of dyslipidemia and coronary artery disease, a glomerular filtration rate (GFR) of 20-60 ml/min, a body mass index (BMI) of 18-30 kg/m2, are 50-75 years old, and have LDL cholesterol \>70 mg/dl despite using equal doses of statins for at least 3 months. Ethics committee approval for the study was obtained from the Istanbul Medipol University "Non-Interventional Clinical Research" ethics committee. Randomly selected participants of similar sizes will be randomly divided into 2 groups. Group A (intervention group) will be asked to use 2 capsules containing 2000 mg (720 mg EPA, 480 mg DHA) omega 3 daily for 12 weeks. The total of these capsules taken in the morning and evening will provide the daily dose. Group B will be the control group. No supplement will be used in this group. Clinical, biochemical and functional status data of each participant will be obtained at the beginning of the study and after the 12-week intervention. Apart from the parameters checked in routine tests (Total cholesterol (mg/dL), LDL-C (mg/dL), HDL-C (mg/dL), triglyceride (mg/dL), CRP (mg/L), fasting blood glucose (mg/dL), calcium (mg/dL), phosphorus (mg/dL), sodium (mg/dL), potassium (mg/dL), Creatine, Urea, Uric acid), Homocysteine, IL-6, TNF-a, Superoxide dismutase (SOD) and Malondialdehyde (MDA) levels will be analyzed in Istanbul Beykent University Multidisciplinary Laboratory. Anthropometric measurements (height, weight) of the patients will be taken. In addition, the food consumption records and food consumption frequencies of the patients will be evaluated with the BeBIS program.

Eligibility

Primary outcome measure(s)

• Change in serum oxidative stress, inflammation, and lipid profile — Baseline and 12 weeks
  To evaluate changes in serum oxidative stress biomarkers (SOD (Superoxide Dismutase), MDA (Malondialdehyde), inflammation biomarkers (IL-6 (Interleukin-6), TNF-α (Tumor Necrosis Alpha), CRP (C-Reactive Protein) and lipid profile (LDL-C, HDL-C, Total cholesterol, Triglycerides) and homocysteine parameters between baseline and the end of the 12-week intervention.

Trial sites (1)

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