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IRCT20260922071163N1 IRCT 2026-10-03 Ahvaz University of Medical Sciences beta Hydroxy beta Methyl Butyrate in Multiple Sclerosis The Effect of beta Hydroxy beta Methyl Butyrate on Disease Progression and Serum Levels of Inflammatory Biomarkers in Patients with Multiple Sclerosis: A Randomized, Double-Blind, Placebo-Controlled Clinical Trial 2026-11-22 anticipated 46 Pending https://irct.ir/trial/93577 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Participants are assigned to either the intervention group (HMB) or the placebo group using block randomization with block sizes of six to maintain a balanced number of participants in each group throughout the study. The blocks are generated using the online software at https://www.sealedenvelope.com/randomisation/, and each participant is identified by a unique code. In the presence of significant confounding variables—such as age, gender, or disease severity—stratified randomization is employed. Individuals are first stratified based on the significant variable, followed by block randomization within each stratum. In this study, patients are assigned via block randomization into two groups of 23 participants each, as follows: Group A (Intervention): Daily intake of 3 g of HMB (hydroxymethylbutyrate) supplement Group B (Control): Daily intake of 3 g of placebo, Blinding description: Participants are assigned to either the intervention group (HMB) or the placebo group using block randomization with block sizes of six to maintain a balanced number of participants in each group throughout the study. The blocks are generated using the online software at https://www.sealedenvelope.com/randomisation/, and each participant is identified by a unique code. Group assignment information is kept in sealed, numbered envelopes to ensure allocation concealment, preventing participants or researchers from knowing the assignment prior to allocation. The study is designed as a double-blind trial; neither the participants nor the researchers administering the supplement/placebo or collecting data will be aware of the group assignments. Only the person responsible for producing and packaging the supplements is aware of the codes and groups and plays no role in data collection or analysis, thereby minimizing the risk of assessor and participant bias. 3 Multiple sclerosis. Intervention 1: Intervention group: Daily intake of 3 grams of hydroxy methyl butyrate (HMB) supplement for 12 weeks. Intervention 2: Control group: Daily intake of 3 g of placebo for 12 weeks. No - There is not a plan to make this available Justification or reason for not sharing IPD is Personal information will be kept confidential, and results will be presented as aggregated statistics.
public Maryam Parsanahad
Department of Nutrition, School of Allied Medical Sciences, Ahvaz Jundishapur University of Medical Sciences, Golestan Street, Ahvaz
Ahvaz Iran (Islamic Republic of) 6135715794 +98 61 3311 5459 m.parsanahad@yahoo.com Ahvaz University of Medical Sciences scientific Maryam Parsanahad
Department of Nutrition, School of Allied Medical Sciences, Ahvaz Jundishapur University of Medical Sciences, Golestan Street, Ahvaz
Ahvaz Iran (Islamic Republic of) 6135715794 +98 61 3311 5459 m.parsanahad@yahoo.com Ahvaz University of Medical Sciences Iran (Islamic Republic of) Diagnosis based on McDonald criteria and MRI Relapsing-remitting clinical status EDSS score ≤ 5.5 Both male and female genders Age between 18 and 60 years Signing the informed consent form; full awareness of study objectives, benefits, and risks 18 years 60 years Both renal issues, hepatic failure, heart failure, rheumatic diseases, diabetes, active cancer, severe or chronic gastrointestinal disorders (e.g., nausea, vomiting, severe diarrhea, or severe stomach pain), and uncontrolled severe psychiatric disorders (e.g., schizophrenia, bipolar disorder type I, or untreated severe depression) use of HMB-containing supplements in the past 3 months use of vitamin, fiber, omega-3, antioxidant, or anti-inflammatory supplements during the 3 weeks prior to the start of the study use of non-steroidal anti-inflammatory drugs (NSAIDs), estrogen, progesterone, diuretics, or corticosteroids inflammatory bowel disease (IBD), rheumatoid arthritis, systemic lupus, type 1 diabetes, and other autoimmune diseases Cigarette smoking Pregnancy, breastfeeding G35 Multiple sclerosis Treatment - Drugs Placebo Intervention group: Daily intake of 3 grams of hydroxy methyl butyrate (HMB) supplement for 12 weeks Control group: Daily intake of 3 g of placebo for 12 weeks Handgrip Strength. Timepoint: Before the intervention and 12 weeks after the start of the intervention. Method of measurement: Using a hand and claw dynamometer. Severity of the disease. Timepoint: Before the intervention and 12 weeks after the start of the intervention. Method of measurement: Assessment of disability severity based on clinical examination (EDSS). Fatigue. Timepoint: Before the intervention and 12 weeks after the start of the intervention. Method of measurement: Score obtained from the FSS questionnaire. Pain. Timepoint: Before the intervention and 12 weeks after the start of the intervention. Method of measurement: Graduated 0–10 scale (VAS). Motor performance. Timepoint: Before the intervention and 12 weeks after the start of the intervention. Method of measurement: T25FW test completion time (time to walk 25 feet). TNF-α. Timepoint: Before the intervention and 12 weeks after the start of the intervention. Method of measurement: ELISA. IL-1. Timepoint: Before the intervention and 12 weeks after the start of the intervention. Method of measurement: ELISA. IL-17. Timepoint: Before the intervention and 12 weeks after the start of the intervention. Method of measurement: ELISA. TGF-β. Timepoint: Before the intervention and 12 weeks after the start of the intervention. Method of measurement: ELISA. IFN-γ. Timepoint: Before the intervention and 12 weeks after the start of the intervention. Method of measurement: ELISA. NO. Timepoint: Before the intervention and 12 weeks after the start of the intervention. Method of measurement: Colorimetric reaction (using a kit). Ahvaz University of Medical Sciences Approved 2026-09-05 Ethics Committee of Ahvaz Jundishapur University of Medical Sciences Ahvaz. Golestan Boulevard. Jundishapur University of Medical Sciences. Deputy for Research. Ahvaz Khouzestan Iran (Islamic Republic of)