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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

Protocol summary

Study aim
Determining the effect of beta-hydroxy-beta-methylbutyrate (HMB) supplementation versus placebo on disease progression and levels of inflammatory biomarkers in patients with multiple sclerosis
Design
A randomized, double-blind, parallel-group, controlled clinical trial with a sample size of 46.
Settings and conduct
Visiting the Khuzestan Province MS Association in the year 1405; selecting 46 patients based on inclusion and exclusion criteria; randomizing them into intervention and control groups; blinding patients and the researcher; and coding performed by a third party unaware of the details
Participants/Inclusion and exclusion criteria
The disease must be diagnosed based on McDonald criteria and MRI findings. The EDSS score must be 5.5 or lower. The patient must have a relapsing-remitting clinical course. The patient's age must be between 18 and 60 years. The patient must not smoke. The patient must not be taking supplements containing HMB, vitamins, fiber, omega-3, antioxidants, or anti-inflammatory agents. The patient must not have any chronic, progressive, or autoimmune diseases.
Intervention groups
Intervention: Daily intake of 3 g of hydroxymethylbutyrate supplement Control: Daily intake of 3 g of placebo
Main outcome variables
Disease severity Fatigue Pain Motor function Handgrip strength

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20260922071163N1
Registration date: 2026-10-03, 1405/07/11
Registration timing: prospective

Last update: 2026-10-03, 1405/07/11
Update count: 0
Registration date
2026-10-03, 1405/07/11
Registrant information
Name
Maryam Parsanahad
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 61 3373 8285
Email address
parsanahad.m@ajums.ac.ir
Recruitment status
Not yet recruiting
Funding source
Expected recruitment start date
2026-11-22, 1405/09/01
Expected recruitment end date
2027-02-20, 1405/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
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
Public title
beta Hydroxy beta Methyl Butyrate in Multiple Sclerosis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
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
Exclusion criteria:
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
Age
From 18 years old to 60 years old
Gender
Both
Phase
3
Groups that have been masked
  • Participant
  • Care provider
  • Investigator
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 46
Randomization (investigator's opinion)
Randomized
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 (investigator's opinion)
Double blinded
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.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Ahvaz Jundishapur University of Medical Sciences
Street address
Ahvaz. Golestan Boulevard. Jundishapur University of Medical Sciences. Deputy for Research.
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Approval date
2026-09-05, 1405/06/14
Ethics committee reference number
IR.AJUMS.REC.1405.266

Health conditions studied

1

Description of health condition studied
Multiple sclerosis
ICD-10 code
G35
ICD-10 code description
Multiple sclerosis

Primary outcomes

1

Description
Handgrip Strength
Timepoint
Before the intervention and 12 weeks after the start of the intervention
Method of measurement
Using a hand and claw dynamometer

2

Description
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)

3

Description
Fatigue
Timepoint
Before the intervention and 12 weeks after the start of the intervention
Method of measurement
Score obtained from the FSS questionnaire

4

Description
pain
Timepoint
Before the intervention and 12 weeks after the start of the intervention
Method of measurement
Graduated 0–10 scale (VAS)

5

Description
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)

Secondary outcomes

1

Description
TNF-α
Timepoint
Before the intervention and 12 weeks after the start of the intervention
Method of measurement
ELISA

2

Description
IL-1
Timepoint
Before the intervention and 12 weeks after the start of the intervention
Method of measurement
ELISA

3

Description
IL-17
Timepoint
Before the intervention and 12 weeks after the start of the intervention
Method of measurement
ELISA

4

Description
TGF-β
Timepoint
Before the intervention and 12 weeks after the start of the intervention
Method of measurement
ELISA

5

Description
IFN-γ
Timepoint
Before the intervention and 12 weeks after the start of the intervention
Method of measurement
ELISA

6

Description
NO
Timepoint
Before the intervention and 12 weeks after the start of the intervention
Method of measurement
Colorimetric reaction (using a kit)

Intervention groups

1

Description
Intervention group: Daily intake of 3 grams of hydroxy methyl butyrate (HMB) supplement for 12 weeks
Category
Treatment - Drugs

2

Description
Control group: Daily intake of 3 g of placebo for 12 weeks
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Khuzestan Province MS Society
Full name of responsible person
Davood Shalilahmadi
Street address
Golestan Street, Ahvaz Jundishapur University of Medical Sciences
City
Ahvaz
Province
Khouzestan
Postal code
1579461357
Phone
+98 61 3336 2414
Email
shalilahmadi.d@ajums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Dr. Abdollah Rafiei
Street address
Golestan Street, Ahvaz Jundishapur University of Medical Sciences, Deputy for Research and Technology
City
Ahvaz
Province
Khouzestan
Postal code
1579461357
Phone
+98 61 3336 2414
Email
itc@ajums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahvaz University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Maryam Parsanahad
Position
PhD Student in Nutrition
Latest degree
Master
Other areas of specialty/work
Nutrition
Street address
Department of Nutrition, School of Allied Medical Sciences, Ahvaz Jundishapur University of Medical Sciences, Golestan Street, Ahvaz
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 61 3311 5459
Email
m.parsanahad@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Maryam Parsanahad
Position
PhD Student in Nutrition
Latest degree
Master
Other areas of specialty/work
Nutrition
Street address
Department of Nutrition, School of Allied Medical Sciences, Ahvaz Jundishapur University of Medical Sciences, Golestan Street, Ahvaz
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 61 3311 5459
Email
m.parsanahad@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Maryam Parsanahad
Position
PhD Student in nutrition
Latest degree
Master
Other areas of specialty/work
Nutrition
Street address
Golestan street
City
Ahvaz
Province
Khouzestan
Postal code
61357157794
Phone
+98 61 3311 5459
Fax
Email
m.parsanahad@yahoo.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
Personal information will be kept confidential, and results will be presented as aggregated statistics.
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
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