Clinical trial NCT06995586: Dietary Supplements in Patients With Coronary Artery Bypass Grafting for Improving the Quality of Healthcare Delivery.
Official title: The Synergistic Action of Vitamins and Dietary Supplements in Patients With Coronary Artery Bypass Grafting for Improving the Quality of Healthcare Delivery.
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
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
Keywords: Cardio-pulmonary Bypass
Cardiovascular Diseases
Omega-3 polyunsaturated fatty acids
Vitamin C
Antioxidants
Lactulose
Omega-3 supplementation
Supplements
postoperative
Optimal Medical Therapy
CABG
Coronary Artery Bypass Grafting
postoperative depression
Lignin
adsorbent
prebiotics
Lead sponsor: Nicosia General Hospital
Sponsor class: OTHER
Collaborators: name: University of Cyprus
name: AVVA Pharmaceuticals Ltd.
First posted: 2025-05-29
Enrollment: 108
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: PREVENTION

Brief 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.

Detailed description: Background: Cardiovascular disease (CVD) remains the leading cause of death worldwide. CVD is the result of disorders of the heart and blood vessels and includes cerebrovascular disease, coronary artery disease (CAD) and peripheral arterial disease. The main mechanism believed to cause CAD is atherosclerosis, in which the arteries become narrowed by plaques or atheroma. While arteries can naturally become harder and narrower with age, this process can be accelerated by factors such as smoking, high cholesterol, high blood pressure, obesity, a sedentary lifestyle and ethnicity. Prevention of CAD by targeting modifiable factors remains a key public health priority. Diet plays an important role in the etiology of many chronic diseases including CAD, thus contributing to a significant geographic variability in morbidity and mortality rates between different countries and populations worldwide. A number of dietary factors have been found to be associated with CAD risk and can be modified to reduce CAD risk with interventions aimed at CAD prevention and management. 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.

Objectives of the study: Our work, which is unique in its kind, is expected to highlight and help establish the administration of the proposed formulations (Vitamin C, EPO/DHA, Lignin, Lactulose) as an integral part of optimal medical therapy (OMT) after interventions in the coronary vessels. It will also form the basis for further research regarding the combined physiological mechanisms of action of the vitamins in question (Vitamin C, EPO/DHA, Lignin, Lactulose) both at the histological and cellular level.

Description of methods including collection and analysis: This is a randomized and controlled trial with an intervention group that will be administered orally daily in addition to the 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. The intervention will take place from the 15th postoperative day (POD) when CAGB patients are discharged and lasts for 2.5 months (10 weeks) PO. The data will be collected on the 15th, 80-90th POD in 6 months and 12 months PO 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 3 years from the day of its initiation. The subjects will be people 40-80 years old, with coronary artery disease, and mental clarity without any psychiatric, neurological or motor disorder 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). A total of at least 108 subjects are required for both groups (54 in each group). In this way, a 40% incidence could be detected in the control group with a 16% incidence in the intervention group (Vitamin C, EPO/DHA, Lignin, Lactulose), i.e. a reduction of around 60% (Alpha 5%, Beta 20%, Power 80%). Once informed consent and written consent have been obtained from a subject and satisfactory inclusion and exclusion criteria have been verified, the individual will be assigned to a group and undergo physical examinations and laboratory blood tests to confirm their status. Each subject will be randomly assigned to each group using a random number generator that assigns each subject to each group in a blinded fashion. A questionnaire asking patients about their experience and opinion of the quality of our services and the patients' quality of life before and after surgery will also be distributed, as well as a consent form to enroll in the study. The data will be collected during the 1st to 4th PO appointment namely the 15th POD, the 80-90th POD in 6 months and 12 months PO in a database on a computer of our hospital and then the statistical analysis of the data will be carried out with the appropriate software. All appropriate parametric and non-parametric statistical analyzes will be performed accordingly (X2 test, Logistic Regression, Linear Regression, Analysis of Variance (ANOVA), Log Rank test, Cox hazard model, ROC curve, etc.). Appropriate statistical analysis software (IBM® SPSS®) will be applied and in addition, assistance from a specialist statistician will be requested for highly specialized analyses.

Project Innovation and Originality: 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.

Dissemination of findings: The results of our study, which is part of Dr. Athanasiou's doctoral thesis at the Open University of Cyprus under the supervision of Dr. Soteriades, will be shared and published both in the domestic and international scientific press and will be freely accessible through the servers of the Open University of Cyprus. There will be no royalties and no charge for acquiring the original work and publications.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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.
* Previous use of any probiotics, prebiotics, adsorbent dietary supplements, Vitamin C and/or Omega 3 fatty acids.

Primary outcomes:
measure: Postoperative decrease in morbidity/mortality associated with our intervention complementary to OMT (Vit C, n-3 PUFA, Lignin and Lactulose)
timeFrame: 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:
measure: Overall Quality Assesment. Assesment of the quality of the service provided to the patients & overall quality of life of our patients postoperatively.
timeFrame: 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.
measure: Postoperative Mental Status of the patients.
timeFrame: 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:
measure: Full blood count (FBC) examination postoperatively during the follow up period.
timeFrame: 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.
measure: Biochemical analysis postoperatively during the follow up period.
timeFrame: 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.
measure: C reactive protein (CRP) examination postoperatively during the follow up period.
timeFrame: 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.
measure: Echocardiographic examination postoperatively during the follow up period.
timeFrame: 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.
measure: Radiologic examinations postoperatively during the follow up period.
timeFrame: 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.
measure: Physical examination (weight measurement) postoperatively during the follow up period.
timeFrame: 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.
Locations:
city: Strovolos
country: Cyprus
facility: Nicosia General Hospital
state: Nicosia
Study officials:
affiliation: Open University of Cyprus
name: Elpidoforos S. Soteriades, MD, Ass Prof
role: STUDY_CHAIR
affiliation: Nicosia General Hospital
name: Athanasios D. Athanasiou, MD, MSc, MPA
role: PRINCIPAL_INVESTIGATOR
affiliation: Open University of Cyprus
name: Elpidoforos S. Soteriades, MD, Ass Prof
role: STUDY_DIRECTOR
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