Cardio-pulmonary BypassNCT06995586
Dietary Supplements in Patients With Coronary Artery Bypass Grafting for Improving the Quality of Healthcare Delivery.
A study testing Vitamin C, Omega 3 PUFA (EPO/DHA), Lignin, Lactulose in people with Cardio-pulmonary Bypass and Cardiovascular Diseases, run by Nicosia General Hospital at 1 site in Cyprus.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Cardio-pulmonary Bypass, Cardiovascular Diseases, Omega-3 Polyunsaturated Fatty Acids
- What is being tested?
- Vitamin C, Omega 3 PUFA (EPO/DHA), Lignin, Lactulose
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 108 participants
- Where
- 1 siteCyprus
- Study dates
- 1 Sep 2026to 1 Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: The Synergistic Action of Vitamins and Dietary Supplements in Patients With Coronary Artery Bypass Grafting for Improving the Quality of Healthcare Delivery.
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.
Read the 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.
- Conditions
- Cardio-pulmonary Bypass, Cardiovascular Diseases, Omega-3 Polyunsaturated Fatty Acids, Omega-3 Supplementation, Vitamin C, Supplements
- Being tested
- Vitamin C, Omega 3 PUFA (EPO/DHA), Lignin, Lactulose
- 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
- Medical subject headings
- Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin C, Omega 3 PUFA (EPO/DHA), Lignin, LactuloseDietary 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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group (OMT & Supplements) | Experimental | This is a randomized and controlled trial with an intervention group that will be administered orally daily 1000 mg Vitamin C, 840 mg EPO/DHA, 2130 mg Lignin \& 720 mg Lactulose in addition to the Optimal Medical Therapy (OMT). Receives: Dietary Supplement: Vitamin C, Omega 3 PUFA (EPO/DHA), Lignin, Lactulose |
| Control group (OMT) | No intervention | This is a randomized and controlled trial with an intervention group and a control group that will receive only the Optimal Medical Therapy (OMT). |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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 (2)
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.
Measured: 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.
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.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2025
- Study start1 Sep 2026 (estimated)
- Primary completion1 Dec 2027 (estimated)
- Study completion1 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (397)Papers the sponsor has linked to this study.
- Other trials for Cardio-pulmonary BypassStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 108 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nicosia General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University of Cyprus, AVVA Pharmaceuticals Ltd.
- Responsible party
- Principal investigator, Athanasios Athanasiou, Nicosia General Hospital
- Investigators
- Elpidoforos S. Soteriades, MD, Ass Prof, Study chair, Open University of CyprusAthanasios D. Athanasiou, MD, MSc, MPA, Principal investigator, Nicosia General HospitalElpidoforos S. Soteriades, MD, Ass Prof, Study director, Open University of Cyprus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06995586
- Sponsor's protocol ID
- 36/22
- Other IDs
- Research Proposal: RP/2022/35
- Status last verified
- May 2026
- First submitted
- 25 Apr 2025
- Last updated
- 13 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Miloyan, B., Eaton, W.W. (2021). The Center for Epidemiologic Studies Depression (CES-D) Scale. In: Gu, D., Dupre, M.E. (eds) Encyclopedia of Gerontology and Population Aging. Springer, Cham. https://doi.org/10.1007/978-3-030-22009-9_416
Siddaway AP, Wood AM, Taylor PJ. The Center for Epidemiologic Studies-Depression (CES-D) scale measures a continuum from well-being to depression: Testing two key predictions of positive clinical psychology. J Affect Disord. 2017 Apr 15;213:180-186. doi: 10.1016/j.jad.2017.02.015. Epub 2017 Feb 20.
PubMed 28254608Zhao YC, Wang CC, Yang JY, Li XY, Yanagita T, Xue CH, Zhang TT, Wang YM. N-3 PUFA Deficiency from Early Life to Adulthood Exacerbated Susceptibility to Reactive Oxygen Species-Induced Testicular Dysfunction in Adult Mice. J Agric Food Chem. 2023 May 10;71(18):6908-6919. doi: 10.1021/acs.jafc.2c07328. Epub 2023 Apr 25.
PubMed 37098125Madore C, Nadjar A, Delpech JC, Sere A, Aubert A, Portal C, Joffre C, Laye S. Nutritional n-3 PUFAs deficiency during perinatal periods alters brain innate immune system and neuronal plasticity-associated genes. Brain Behav Immun. 2014 Oct;41:22-31. doi: 10.1016/j.bbi.2014.03.021. Epub 2014 Apr 13.
PubMed 24735929Cole GM, Ma QL, Frautschy SA. Omega-3 fatty acids and dementia. Prostaglandins Leukot Essent Fatty Acids. 2009 Aug-Sep;81(2-3):213-21. doi: 10.1016/j.plefa.2009.05.015. Epub 2009 Jun 12.
PubMed 19523795Delpech JC, Thomazeau A, Madore C, Bosch-Bouju C, Larrieu T, Lacabanne C, Remus-Borel J, Aubert A, Joffre C, Nadjar A, Laye S. Dietary n-3 PUFAs Deficiency Increases Vulnerability to Inflammation-Induced Spatial Memory Impairment. Neuropsychopharmacology. 2015 Nov;40(12):2774-87. doi: 10.1038/npp.2015.127. Epub 2015 May 7.
PubMed 25948102Aid S, Vancassel S, Poumes-Ballihaut C, Chalon S, Guesnet P, Lavialle M. Effect of a diet-induced n-3 PUFA depletion on cholinergic parameters in the rat hippocampus. J Lipid Res. 2003 Aug;44(8):1545-51. doi: 10.1194/jlr.M300079-JLR200. Epub 2003 May 16.
PubMed 12754277Belkouch M, Hachem M, Elgot A, Lo Van A, Picq M, Guichardant M, Lagarde M, Bernoud-Hubac N. The pleiotropic effects of omega-3 docosahexaenoic acid on the hallmarks of Alzheimer's disease. J Nutr Biochem. 2016 Dec;38:1-11. doi: 10.1016/j.jnutbio.2016.03.002. Epub 2016 Mar 24.
PubMed 27825512McNamara RK, Almeida DM. Omega-3 Polyunsaturated Fatty Acid Deficiency and Progressive Neuropathology in Psychiatric Disorders: A Review of Translational Evidence and Candidate Mechanisms. Harv Rev Psychiatry. 2019 Mar/Apr;27(2):94-107. doi: 10.1097/HRP.0000000000000199.
PubMed 30633010Palacios-Pelaez R, Lukiw WJ, Bazan NG. Omega-3 essential fatty acids modulate initiation and progression of neurodegenerative disease. Mol Neurobiol. 2010 Jun;41(2-3):367-74. doi: 10.1007/s12035-010-8139-z. Epub 2010 May 14.
PubMed 20467837Leyrolle Q, Decoeur F, Dejean C, Briere G, Leon S, Bakoyiannis I, Baroux E, Sterley TL, Bosch-Bouju C, Morel L, Amadieu C, Lecours C, St-Pierre MK, Bordeleau M, De Smedt-Peyrusse V, Sere A, Schwendimann L, Gregoire S, Bretillon L, Acar N, Joffre C, Ferreira G, Uricaru R, Thebault P, Gressens P, Tremblay ME, Laye S, Nadjar A. N-3 PUFA deficiency disrupts oligodendrocyte maturation and myelin integrity during brain development. Glia. 2022 Jan;70(1):50-70. doi: 10.1002/glia.24088. Epub 2021 Sep 14.
PubMed 34519378Wang DD, Wu F, Zhang LY, Zhao YC, Wang CC, Xue CH, Yanagita T, Zhang TT, Wang YM. Effects of dietary n-3 PUFA levels in early life on susceptibility to high-fat-diet-induced metabolic syndrome in adult mice. J Nutr Biochem. 2021 Mar;89:108578. doi: 10.1016/j.jnutbio.2020.108578. Epub 2020 Dec 31.
PubMed 33388352Zou HY, Zhang HJ, Zhao YC, Li XY, Wang YM, Zhang TT, Xue CH. N-3 PUFA Deficiency Aggravates Streptozotocin-Induced Pancreatic Injury in Mice but Dietary Supplementation with DHA/EPA Protects the Pancreas via Suppressing Inflammation, Oxidative Stress and Apoptosis. Mar Drugs. 2023 Jan 1;21(1):39. doi: 10.3390/md21010039.
PubMed 36662212Ramirez JL, Zahner GJ, Spaulding KA, et al. HHS Public Access. 2020;54:211-19.
Catry E, Neyrinck AM, Lobysheva I, Pachikian BD, Van Hul M, Cani PD, Dessy C, Delzenne NM. Nutritional depletion in n-3 PUFA in apoE knock-out mice: A new model of endothelial dysfunction associated with fatty liver disease. Mol Nutr Food Res. 2016 Oct;60(10):2198-2207. doi: 10.1002/mnfr.201500930. Epub 2016 Jun 1.
PubMed 27136390
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Synergistic Action of Vitamins and Dietary Supplements in Patients With Coronary Artery Bypass Grafting for Improving the Quality of Healthcare Delivery.
- ClinicalTrials.gov ID
- NCT06995586
- Acronym / sponsor ID
- 36/22
- Conditions
- Cardio-pulmonary Bypass, Cardiovascular Diseases, Omega-3 Polyunsaturated Fatty Acids, Omega-3 Supplementation, Vitamin C, Supplements
- Keywords
- Cardio-pulmonary Bypass, Cardiovascular Diseases, Omega-3 polyunsaturated fatty acids, Vitamin C, Antioxidants, Lactulose, Omega-3 supplementation, Supplements
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 108 participants (estimated)
- Lead sponsor
- Nicosia General HospitalUniversity, hospital or other
- Collaborators
- University of Cyprus, AVVA Pharmaceuticals Ltd.
- Study start
- 1 Sep 2026 (estimated)
- Primary completion
- 1 Dec 2027 (estimated)
- Study completion
- 1 Dec 2028 (estimated)
- First posted
- 29 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Intervention group (OMT & Supplements) | Experimental | Dietary Supplement: Vitamin C, Omega 3 PUFA (EPO/DHA), Lignin, LactuloseThis is a randomized and controlled trial with an intervention group that will be administered orally daily 1000 mg Vitamin C, 840 mg EPO/DHA, 2130 mg Lignin \& 720 mg Lactulose in addition to the Optimal Medical Therapy (OMT). |
| Control group (OMT) | No intervention | –This is a randomized and controlled trial with an intervention group and a control group that will receive only the Optimal Medical Therapy (OMT). |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vitamin C, Omega 3 PUFA (EPO/DHA), Lignin, LactuloseThis 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. | Dietary supplement | Intervention group (OMT & Supplements) |
Primary outcome
Postoperative decrease in morbidity/mortality associated with our intervention complementary to OMT (Vit C, n-3 PUFA, Lignin and Lactulose)
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.
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.
2 secondary outcomes
Overall Quality Assesment. Assesment of the quality of the service provided to the patients & overall quality of life of our patients 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.
Postoperative Mental Status of the patients.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2026.
- BackgroundMiloyan, B., Eaton, W.W. (2021). The Center for Epidemiologic Studies Depression (CES-D) Scale. In: Gu, D., Dupre, M.E. (eds) Encyclopedia of Gerontology and Population Aging. Springer, Cham. https://doi.org/10.1007/978-3-030-22009-9_416
- Background: PubMed 28254608Siddaway AP, Wood AM, Taylor PJ. The Center for Epidemiologic Studies-Depression (CES-D) scale measures a continuum from well-being to depression: Testing two key predictions of positive clinical psychology. J Affect Disord. 2017 Apr 15;213:180-186. doi: 10.1016/j.jad.2017.02.015. Epub 2017 Feb 20.
- Background: PubMed 37098125Zhao YC, Wang CC, Yang JY, Li XY, Yanagita T, Xue CH, Zhang TT, Wang YM. N-3 PUFA Deficiency from Early Life to Adulthood Exacerbated Susceptibility to Reactive Oxygen Species-Induced Testicular Dysfunction in Adult Mice. J Agric Food Chem. 2023 May 10;71(18):6908-6919. doi: 10.1021/acs.jafc.2c07328. Epub 2023 Apr 25.
- Background: PubMed 24735929Madore C, Nadjar A, Delpech JC, Sere A, Aubert A, Portal C, Joffre C, Laye S. Nutritional n-3 PUFAs deficiency during perinatal periods alters brain innate immune system and neuronal plasticity-associated genes. Brain Behav Immun. 2014 Oct;41:22-31. doi: 10.1016/j.bbi.2014.03.021. Epub 2014 Apr 13.
- Background: PubMed 19523795Cole GM, Ma QL, Frautschy SA. Omega-3 fatty acids and dementia. Prostaglandins Leukot Essent Fatty Acids. 2009 Aug-Sep;81(2-3):213-21. doi: 10.1016/j.plefa.2009.05.015. Epub 2009 Jun 12.
- Background: PubMed 25948102Delpech JC, Thomazeau A, Madore C, Bosch-Bouju C, Larrieu T, Lacabanne C, Remus-Borel J, Aubert A, Joffre C, Nadjar A, Laye S. Dietary n-3 PUFAs Deficiency Increases Vulnerability to Inflammation-Induced Spatial Memory Impairment. Neuropsychopharmacology. 2015 Nov;40(12):2774-87. doi: 10.1038/npp.2015.127. Epub 2015 May 7.
- Background: PubMed 12754277Aid S, Vancassel S, Poumes-Ballihaut C, Chalon S, Guesnet P, Lavialle M. Effect of a diet-induced n-3 PUFA depletion on cholinergic parameters in the rat hippocampus. J Lipid Res. 2003 Aug;44(8):1545-51. doi: 10.1194/jlr.M300079-JLR200. Epub 2003 May 16.
- Background: PubMed 27825512Belkouch M, Hachem M, Elgot A, Lo Van A, Picq M, Guichardant M, Lagarde M, Bernoud-Hubac N. The pleiotropic effects of omega-3 docosahexaenoic acid on the hallmarks of Alzheimer's disease. J Nutr Biochem. 2016 Dec;38:1-11. doi: 10.1016/j.jnutbio.2016.03.002. Epub 2016 Mar 24.
- Background: PubMed 30633010McNamara RK, Almeida DM. Omega-3 Polyunsaturated Fatty Acid Deficiency and Progressive Neuropathology in Psychiatric Disorders: A Review of Translational Evidence and Candidate Mechanisms. Harv Rev Psychiatry. 2019 Mar/Apr;27(2):94-107. doi: 10.1097/HRP.0000000000000199.
- Background: PubMed 20467837Palacios-Pelaez R, Lukiw WJ, Bazan NG. Omega-3 essential fatty acids modulate initiation and progression of neurodegenerative disease. Mol Neurobiol. 2010 Jun;41(2-3):367-74. doi: 10.1007/s12035-010-8139-z. Epub 2010 May 14.
- Background: PubMed 34519378Leyrolle Q, Decoeur F, Dejean C, Briere G, Leon S, Bakoyiannis I, Baroux E, Sterley TL, Bosch-Bouju C, Morel L, Amadieu C, Lecours C, St-Pierre MK, Bordeleau M, De Smedt-Peyrusse V, Sere A, Schwendimann L, Gregoire S, Bretillon L, Acar N, Joffre C, Ferreira G, Uricaru R, Thebault P, Gressens P, Tremblay ME, Laye S, Nadjar A. N-3 PUFA deficiency disrupts oligodendrocyte maturation and myelin integrity during brain development. Glia. 2022 Jan;70(1):50-70. doi: 10.1002/glia.24088. Epub 2021 Sep 14.
- Background: PubMed 33388352Wang DD, Wu F, Zhang LY, Zhao YC, Wang CC, Xue CH, Yanagita T, Zhang TT, Wang YM. Effects of dietary n-3 PUFA levels in early life on susceptibility to high-fat-diet-induced metabolic syndrome in adult mice. J Nutr Biochem. 2021 Mar;89:108578. doi: 10.1016/j.jnutbio.2020.108578. Epub 2020 Dec 31.
- World Health Organization. (2014). Global status report on noncommunicable diseases 2014. WHO/NMH/NVI/15.1 World Health Organization.Link provided by the sponsor.
- World Health Organization. (2021). Cardiovascular diseases (CVDs) factsheet. Updated June 2021.Link provided by the sponsor.
- World Health Organization. (2003). Diet, nutrition and the prevention of chronic diseases : report of a joint WHO/FAO expert consultation, Geneva, 28 January - 1 February 2002. World Health Organization.Link provided by the sponsor.
- Doherty, W. O. S., Mousavioun, P., \& Fellows, C. M. (2011). Value-adding to cellulosic ethanol: Lignin polymers. Industrial Crops and Products, 33(2), 259-276.Link provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Elpidoforos S. Soteriades, MD, Ass Prof study chair
Open University of Cyprus
Athanasios D. Athanasiou, MD, MSc, MPA principal investigator
Nicosia General Hospital
Elpidoforos S. Soteriades, MD, Ass Prof study director
Open University of Cyprus
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vitamin C, Omega 3 PUFA (EPO/DHA), Lignin, Lactulose in people with Cardio-pulmonary Bypass and Cardiovascular Diseases, run by Nicosia General Hospital at 1 site in Cyprus.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 13 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Cyprus. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Athanasios D. Athanasiou, MD, MSc, MPA (+357 99291629, drathanasiou@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative decrease in morbidity/mortality associated with our intervention complementary to OMT (Vit C, n-3 PUFA, Lignin and Lactulose) (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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06995586, which also lists 397 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 May 2026.