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IRCT20091114002709N68 IRCT 2026-03-31 Iran University of Medical Sciences The Effect of Dark Chocolate Consumption on Serum Levels of Lipoprotein(a), Apolipoprotein A-1, Apolipoprotein B, Inflammatory Markers, Oxidative Stress, lipid profile, health-related quality of life and symptoms of anxiety and depression in Hemodialysis Patients The Effect of Dark Chocolate Consumption on Serum Levels of Lipoprotein(a), Apolipoprotein A-1, Apolipoprotein B, Inflammatory Markers, Oxidative Stress, lipid profile, health-related quality of life and symptoms of anxiety and depression in Hemodialysis Patients 2026-04-21 anticipated 70 Complete https://irct.ir/trial/89331 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: Participants will be allocated to the intervention and control groups in this study using the randomized block method with the blockrand package in the R programming environment. The main goal of employing this method is to maintain balance in the number of individuals in each group during the data collection process and prevent imbalances resulting from the timing of participant recruitment. In the randomized block method, allocation occurs in consecutive blocks; such that in each block, an equal number of individuals are assigned to the intervention and control groups. In this study, a block size of 4 has been selected; meaning that in each block, two individuals are assigned to the intervention group (A) and two to the control group (B). The order of individuals within each block is determined randomly to reduce the predictability of the allocation pattern. N/A Hemodialysis patients. Intervention 1: Intervention group: Patients undergoing hemodialysis who will receive a specified amount of dark chocolate daily for a specified duration, in addition to their usual diet. Intervention 2: Control group: Eligible hemodialysis patients who are randomly assigned to the control group and, throughout the study period, will follow only their usual diet without receiving dark chocolate. Yes - There is a plan to make this available What will be shared: Data related to study outcomes at the end of the study can be shared. When: The access period will be 6 months after publication. To whom: Researchers employed in academic and scientific institutions. Conditions: For the purpose of using the data to conduct another study and apply it to patients. Where to obtain: Name and surname: Dr. Farzad Shidfar Email address: shidfar.f@iums.ac.ir How to obtain: Request via email along with providing complete explanations regarding the reason for needing the data. Comments:
public Farzad Shidfar
School of Health, Iran University of Medical Sciences, Shahid Hemmat highway
Tehran Iran (Islamic Republic of) 1449614535 +98 21 8862 2755 shidfar.f@iums.ac.ir Iran University of Medical Sciences scientific Farzad shidfar
Shahid hemmat expressway
Tehran Iran (Islamic Republic of) 1449614525 +98 21 8860 2218 farzadshidfar@yahoo.com Iran University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Patient's consent to participate in the study and signify informed consent form The number of hemodialysis three times per week At least three months of history of hemodialysis BMI>30 18 years 65 years Both Active infectious diseases including hepatitis and malignancies Allergy or intolerance to dark chocolate in the intervention group Regular consumption of dark chocolate in the daily diet Being on the threshold of kidney transplantation Consumption of antioxidant supplements or similar herbal products in the past 3 months Z99.2 Dependence on renal dialysis Lifestyle Lifestyle Intervention group: Patients undergoing hemodialysis who will receive a specified amount of dark chocolate daily for a specified duration, in addition to their usual diet. Control group: Eligible hemodialysis patients who are randomly assigned to the control group and, throughout the study period, will follow only their usual diet without receiving dark chocolate. Lipoprotein (a). Timepoint: The beginning of the study (before the start of the intervention), the end of the study (8 weeks after the start of the intervention). Method of measurement: Immunoturbidometric method. Apolipoprotein A-1. Timepoint: The beginning of the study (before the start of intervention), the end of the study (8 weeks after the start of the intervention). Method of measurement: Immunoturbidometric method. Apolipoprotein B. Timepoint: The beginning of the study (before the start of intervention), the end of the study (8 weeks after the start of the intervention). Method of measurement: Immunoturbidometric method. Inflammatory factor IL-6. Timepoint: The beginning of the study (before the start of intervention), the end of the study (8 weeks after the start of the intervention). Method of measurement: ELISA test. MDA. Timepoint: The beginning of the study (before the start of intervention), the end of the study (8 weeks after the start of the intervention). Method of measurement: ELISA test. Lipid profile. Timepoint: The beginning of the study (before the start of intervention), the end of the study (8 weeks after the start of the intervention). Method of measurement: TG, HDL-C and TC concentrations will be measured calorimetrically and LDL-C concentrations will be calculated using the Friedwald formula. .LDL-C (mg/dL) = TC (mg/dL) − HDL-C (mg/dL) – (TG (mg/dL)/5). Anxiety and depression score. Timepoint: The beginning of the study (before the start of intervention), the end of the study (8 weeks after the start of the intervention). Method of measurement: Hospital Anxiety and Depression Scale questionnaire. Health-related quality of life score. Timepoint: The beginning of the study (before the start of intervention), the end of the study (8 weeks after the start of the intervention). Method of measurement: Kidney Disease Quality of Life-36 questionnaire. Blood pressure. Timepoint: The beginning of the study (before the start of intervention), the end of the study (8 weeks after the start of the intervention). Method of measurement: Digital blood pressure monitor. Anthropometric indices. Timepoint: The beginning of the study (before the start of intervention), the end of the study (8 weeks after the start of the intervention). Method of measurement: Standard meter and scale. Iran University of Medical Sciences Approved 2026-01-26 Ethic Committee School of Health, Iran University of Medical Sciences Arjantin Square, Alvand Street, School of Health, Iran University of Medical Sciences Tehran Tehran Iran (Islamic Republic of)