The effect of Lycopene on the expression level of Mir-210, Antioxidant factors and apolipoproteins in patients with ischemic heart failure referring to Isfahan Chamran hospital: A randomized Clinical Trial

Effect of lycopene supplements on micro RNA-210 expression, EF levels, paraoxonase enzyme, antioxidant capacity, lipid profile, and LDL oxidation in heart failure patients

Two-arm, randomized, triple-blind clinical trial was conducted on 48 patients with an intervention group (receiving lycopene tablets) and a control group (receiving placebo).

Chamran Heart Hospital in Isfahan started its operation in March 2024.The clinical trial is a randomized controlled trial with three groups (investigator, executor, and patient) and involves taking about 50 cc of blood from the patient through venipuncture and performing echocardiography.

Male patients aged 40-70 y/0 with ischemic heart failure and ejection fraction ventricular contraction of 20-40 are eligible to participate. Patients with various malignancies, diabetes, autoimmune diseases, history of organ transplant or use of immunosuppressive drugs, respiratory diseases, history of stroke, atrial fibrillation and other cardiac rhythm disorders, recent surgery, active viral or inflammatory diseases, anemia with hemoglobin less than 10 grams per deciliter, body mass index less than 17 and greater than 30, malabsorption, patients who have used any antioxidant within one month prior to the start of the intervention, and tobacco use are excluded from the study.

Intervention group: daily intake of 25 mg lycopene for 8 weeks. Control group receives placebo for 8 weeks.

The effect of consuming lycopene supplements on the expression level of microRNA-210 in plasma; paraoxonase enzyme activity; total antioxidant capacity; lipid profile; and oxidation of LDL and Ejection Fraction in patients with heart failure

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Triple-blind (i.e., triple-masking) studies are randomized experiments in which the treatment or intervention is unknown to (a) the research participant, (b) the individual(s) who administer the treatment or intervention, and (c) the individual(s) who assess the outcomes. The terms blind and masking are synonymous; both terms describe methods that heslp to ensure that individuals do not know which treatment or intervention is being administered. The purpose of triple-blinding procedures is to reduce assessment bias and to increase the accuracy and objectivity of clinical outcomes

Some of the data related to the main outcome will be shared.

Access period starts 6 months after the results are published

Researchers working in academic and scientific institutions

Optimization of this study to help patients

Laila Rejali: lailarejali@yahoo.com Dr.Hashem Nayeri: hnaieri@gmail.com

Official letter to Leila Rejali and Dr. Hashem Nayeri