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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age40-80
SponsorNicosia General Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

The subjects will be people 40-80 years old, with coronary artery disease, and mental clarity who will undergo Coronary Aortic Bypass (CABG) in our clinic (Public Cardiothoracic Surgery clinic in Nicosia General Hospital) and will be randomized into 2 groups (intervention group and control group).

Signed consent form

Ability to adhere to the protocol

Disqualifiers

Any psychiatric, neurological or motor disorder.

Hypersensitivity to the components of the supplement.

Combined Cardiac Surgery other than CABG and valve or aortic

Concurrent participation in other clinical trials.

Trial design

Design model

Parallel

Treatments tested in this trial

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

    Dietary supplement

    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.

Treatment groups

108 Participants
are divided into 2 treatment groups
Group A: Intervention group (OMT & Supplements)Experimental treatment 1 intervention
Group B: Control group (OMT)No intervention 0 interventions

Trial outcomes

Primary outcomes

1

Postoperative decrease in morbidity/mortality associated with our intervention complementary to OMT (Vit C, n-3 PUFA, Lignin and Lactulose)

Optimal Medical Therapy (OMT) postoperatively (PO) is subject to improvement. One of these promising improvements is the addition of (Vitamin C, EPO/DHA, Lignin, Lactulose) proposed by the present study, for which the research in question is being carried out. As far as we know, the proposed study is the first of its kind internationally that studies the combined action of these 4 factors together, which makes it unique. Some degree of improvement in the well-being and clinical picture of our patients PO is expected, which will be thoroughly investigated in each phase of the study. In this way, both the theoretical framework around PO treatment and the clinical practice itself in which we propose to introduce the aforesaid complementary treatment will be improved.

Time frame
The data will be collected on the 15th, 80-90th postop day (POD) in 6 months and 12 months PO and then the statistical analysis of the data will be performed. This study is expected to be completed in approximately 3 years from the day of its initiation.

Secondary outcomes

1

Overall Quality Assesment. Assesment of the quality of the service provided to the patients & overall quality of life of our patients postoperatively.

There will be questionnaires assessing the perceived quality of our health service to the patient as well as objective/actual measurements about the overall quality of life of our patients postoperatively. These data will be assessed in 4 time points postoperatively.

Time frame
The data will be collected on the 15th, 80-90th postop day (POD) in 6 months and 12 months PO and then the statistical analysis of the data will be performed. This study is expected to be completed in approximately 3 years from the day of its initiation.
2

Postoperative Mental Status of the patients.

There will be an internationally standardized questionnaire, namely "The Center for Epidemiologic Studies-Depression scale (CES-D Scale), about the mental status of our patients and it will be assessed in 4 time points postoperatively. The CES-D measures a well-being/depression continuum in adolescents, adults, and older adults. The CES-D total score provides an indication of depressive symptom severity that is based on a combination of the presence/absence of depressive experiences and the presence/absence of well-being. Possible range of scores is 0 to 60, with the higher scores indicating the presence of more symptomatology.

Time frame
The data will be collected on the 15th, 80-90th postop day (POD) in 6 months and 12 months PO and then the statistical analysis of the data will be performed. This study is expected to be completed in approximately 3 years from the day of its initiation.

Other outcomes

1

Full blood count (FBC) examination postoperatively during the follow up period.

Individuals who participate in this study will receive additional follow-up postoperatively for one year according to the protocol and have full blood count (FBC) blood test.

Time frame
The data will be collected on the 15th, 80-90th postop day (POD) in 6 months and 12 months PO and then the statistical analysis of the data will be performed. This study is expected to be completed in approximately 3 years from the day of its initiation.
2

Biochemical analysis postoperatively during the follow up period.

Individuals who participate in this study will receive additional follow-up postoperatively for one year according to the protocol and have biochemical analysis blood test.

Time frame
The data will be collected on the 15th, 80-90th postop day (POD) in 6 months and 12 months PO and then the statistical analysis of the data will be performed. This study is expected to be completed in approximately 3 years from the day of its initiation.
3

C reactive protein (CRP) examination postoperatively during the follow up period.

Individuals who participate in this study will receive additional follow-up postoperatively for one year according to the protocol and have C reactive protein (CRP) examination blood test.

Time frame
The data will be collected on the 15th, 80-90th postop day (POD) in 6 months and 12 months PO and then the statistical analysis of the data will be performed. This study is expected to be completed in approximately 3 years from the day of its initiation.
4

Echocardiographic examination postoperatively during the follow up period.

Individuals who participate in this study will receive additional follow-up postoperatively for one year according to the protocol and have heart Echocardiography.

Time frame
The data will be collected on the 80-90th postop day (POD) in 6 months and 12 months PO and then the statistical analysis of the data will be performed. This study is expected to be completed in approximately 3 years from the day of its initiation.

Sponsors and contacts

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Nicosia General Hospital

Lead sponsor

University of Cyprus

Collaborator

AVVA Pharmaceuticals Ltd.

Collaborator

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