Dietary Supplements in Patients With Coronary Artery Bypass Grafting for Improving the Quality of Healthcare Delivery.

Summary

Cardiovascular disease (CVD) remains the leading cause of death worldwide. Prevention of CAD by targeting modifiable factors remains a key public health priority. L-Ascorbic Acid (Vitamin C - Vit. C) and Omega 3 fatty acids, Eicosapentaenoic / Docosahexaenoic Acid (EPO/DHA), powerful but also necessary antioxidants for the human body, after observational studies as well as randomized studies seem to have a beneficial effect in the direction of the prevention of CVD with pleiotropic mechanisms. Lignin, a polymer of plant origin that is considered a dietary fiber, has a developed porous structure and can retain exogenous and endogenous toxins, and pathogenic microorganisms. Lactulose considered a prebiotic provides a selective substrate for the metabolism of saccharolytic bacteria with bifidogenic activity and multiple benefits to the host's gut health. Coronary artery bypass grafting (CABG) is an established surgical intervention and treatment of symptoms of myocardial ischemia that improves patient survival Optimal Medical Therapy (OMT) after coronary arterial bypass grafting (CABG) as described in current clinical practice could be made even better by the addition of these beneficial food supplements.

A randomized controlled trial is proposed in an intervention group of 54 post-CABG patients who will be given daily orally in addition to the usual medication, 1000 mg Vitamin C, 840 mg EPO/DHA, 2130 mg Lignin \& 720 mg Lactulose and a control group of 54 patients (Control Group) in which only usual medication will be administered. The intervention will take place from the 15th postoperative day when CAGB patients are discharged and lasts for 2.5 months (10 weeks) postoperatively. The data will be collected on the 15th, 80-90th postop day in 6 months and 12 months postop and then the statistical analysis of the data will be performed. Considering the number of CABG surgeries performed electively in our clinic, this study is expected to be completed in approximately 2-3 years from the day of initiation.

The expected knowledge through the expected results such as these will emerge from this study is the potentially beneficial effect of our food supplements administration (intervention), i.e. Vitamin C, EPO/DHA, Lignin \& Lactulose, on the postoperative course of our patients. Some degree of improvement in the well-being and clinical picture of our patients postoperatively is expected, which will be thoroughly investigated in each phase of the study.

Conditions

• Cardio-pulmonary Bypass
• Cardiovascular Diseases
• Omega-3 Polyunsaturated Fatty Acids
• Omega-3 Supplementation
• Vitamin C
• Supplements
• Postoperative Depression
• Antioxidants
• Lactulose
• Postoperative
• Optimal Medical Therapy
• CABG
• Coronary Artery Bypass Grafting
• Prebiotics

Interventions

DIETARY_SUPPLEMENT

Vitamin C, Omega 3 PUFA (EPO/DHA), Lignin, Lactulose

This is a randomized and controlled trial with an intervention group that will be administered orally daily in addition to the Optimal Medical Therapy (OMT), namely 1000 mg Vitamin C, 840 mg EPO/DHA, 2130 mg Lignin \& 720 mg Lactulose and a control group that will receive only the OMT.

Sponsors & Collaborators

• University of Cyprus

  collaborator OTHER

• AVVA Pharmaceuticals Ltd.

  collaborator INDUSTRY

• Nicosia General Hospital

  lead OTHER

Principal Investigators

• Elpidoforos S. Soteriades, MD, Ass Prof · Open University of Cyprus

• Athanasios D. Athanasiou, MD, MSc, MPA · Nicosia General Hospital

• Elpidoforos S. Soteriades, MD, Ass Prof · Open University of Cyprus

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

40 Years

Max Age

80 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-09-01

Primary Completion

2027-12-01

Completion

2028-12-01

Countries

• Cyprus

Study Locations