Coronary heart disease (CHD) Circulatory System
Conditions
Interventions
This is a randomized double-blind versus placebo clinical trial based on the administration of ALFALIFE™ supplements in patients with a balanced hypolipidemic and isocaloric diet. ALFALIFE™ is presen
the placebo contains edible oil and is presented in soft capsules that appear identical to ALFALIFE™. Both arms will receive six capsules/day (one at breakfast, two at lunch, and three at supper) for
Sponsors
Lugo Medica
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients with non-optimal ALA intake ( 30 (patient with very high levels > 80 are also included and will be flagged for further subgroup analysis) 5. Patients with mixed hyperlipoproteinemia (type IIb) or hypercholesterolemia (type IIa), with metabolic syndrome (according to ATP III classification) or overweight
Exclusion criteria
Exclusion criteria: 1. Patients with secondary hypercholesterolaemia and endocrinopathies, even if borderline or if the condition is only suspected. 2. Patients with type 1 or 2 diabetes (or 1-5 according to the new Lancet Endocrinology 2018 classification) 3. Patients who usually take over-the-counter self-prescribed drugs or supplements, or who use generic dietary formats, which are not reliable from a scientific point of view 4. Patients being treated with drugs (any type) or nutritional supplements (any type) or who are expected to start treatments during the study period 5. Patients with clinical symptoms or instrumental laboratory parameters such as to suggest the presence of acute or subacute viral/bacterial infection or other inflammations 6. Patients who for ethical reasons need lipid-lowering or antithrombophilic therapy (patients with very high cardiovascular risk, patients with severe and/or unstable atheromasia, in any vascular district, patients with a history of angina, thromboembolism, TIA, heart infarction, stroke, etc) 7. Exclusion of menopausal, premenopausal and postmenopausal women under treatment or with active post-menopausal symptoms 8. Patients with secondary metabolic diseases, endocrinopathies, and systemic diseases of any kind, patients with disabilities/disabilities/functional limitations 9. Patients with severe depressive syndromes and other psychiatric diagnosis 10. Patients who for any reason cannot follow the periodic checks aimed to assess their diet and the adherence to the study 11. Patients with previous bulimia/anorexia, patients with recent (within 3 months) strong drop or weight increase, weight fluctuations greater than the sum of the analytical and pre-analytical variability physiological according to gender, age and weight, or weight trend on multiple measures constantly increasing or decreasing 12. Patients with BMI> 30, as per generic classification of obesity 13. Patients with food intolerances (unless these are attributable to LGI, with the exclusion of other causes, lactose, nickel, celiac disease, etc., intolerances) and vegan/vegetarian patients or for any other reason subject to food restrictions
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Cholesterol Tot measured using enzymatic reaction at baseline, 30 days (end of wash-out phase), 90 days, 150 days, and 180 days 2. LDLc measured using enzymatic reaction at baseline, 30 days (end of wash-out phase), 90 days, 150 days, and 180 days 3. HDLc triglycerides measured using enzymatic reaction at baseline, 30 days (end of wash-out phase), 90 days, 150 days, and 180 days 4. Lp (a) measured using ELISA at baseline, 30 days (end of wash-out phase), 90 days, 150 days, and 180 days 5. Glycemia measured using enzymatic reaction at baseline, 30 days (end of wash-out phase), 90 days, 150 days, and 180 days 6. Glycated haemoglobin measured using ELISA at baseline, 30 days (end of wash-out phase), 90 days, 150 days, and 180 days 7. HOMA-IR measured at baseline, 30 days (end of wash-out phase), 90 days, 150 days, and 180 days 8. HOMA-B measured at baseline, 30 days (end of wash-out phase), 90 days, 150 days, and 180 days 9. Leptin measured using ELISA at baseline, 30 days (end of wash-out phase), 90 days, 150 days, and 180 days 10. Ghrelin measured using ELISA at baseline, 30 days (end of wash-out phase), 90 days, 150 days, and 180 days 11. VCAM measured using ELISA at baseline, 30 days (end of wash-out phase), 90 days, 150 days, and 180 days 12. ICAM measured using ELISA at baseline, 30 days (end of wash-out phase), 90 days, 150 days, and 180 days 13. Endothelin measured using ELISA at baseline, 30 days (end of wash-out phase), 90 days, 150 days, and 180 days 14. Homocysteine measured using ELISA at baseline, 30 days (end of wash-out phase), 90 days, 150 days, and 180 days 15. Fibrinogen measured using ELISA at baseline, 30 days (end of wash-out phase), 90 days, 150 days, and 180 days 16. Uricemia measured at baseline, 30 days ( | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. The number of visualized plaques, as well as the total plaque area or total plaque volume, measured using supra-aortic trunk artery echo-Doppler at baseline and 120 days 2. The number of visualized plaques, as well as the total plaque area or total plaque volume, measured using aortic artery echo-Doppler at baseline and 120 days 3. The number of visualized plaques, as well as the total plaque area or total plaque volume, measured using renal artery echo-Doppler at baseline and 120 days 4. The number of visualized plaques, as well as the total plaque area or total plaque volume, measured using femoral artery echo-Doppler at baseline and 120 days | — |
Countries
Italy
Contacts
Public ContactPasquale;Michela Ortasi;Dimilta
;
Outcome results
None listed