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Effect of Ellagic acid supplementation on disease severity, expression of involved genes in pathogenesis, and levels of immunity and inflammatory biomarkers in patients with Multiple Sclerosis

Protocol summary

Study aim
Determination of the ellagic acid supplementation effects in comparison to placebo on disease severity, IL-17, IL-4, IFNγ and TGF-β cytokines and expression of Tbet, GATA3, RORγt and FOXP3 genes in patients with MS
Design
Clinical trial with control group, with parallel groups, double blind, randomized, phase 3 on 46 patients. The balanced block method will be used for randomization.
Settings and conduct
Among the patients referred to Firoozgar Hospital MS Clinic, patients who meet the study inclusion criteria, are randomly assigned to one of the two groups receiving ellagic acid supplement and placebo. None of the patients, as well as the researcher, will know the group in which the patients are and the type of intervention received.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Patient informed consent, disease diagnosis based on McDonald's criteria and MRI by a neurologist, EDSS score less than 5.5, relapsing-remitting status of the disease, age between 18 and 55 years. Exclusion criteria: Reluctance to participate in the study, take nutritional supplements, antioxidants, and ellagic acid during a month before the start of the study and during the study, taking nonsteroidal anti-inflammatory drugs, estrogen, progesterone, immunosuppressives, diuretics, and corticosteroids during a month before the study, patients with inflammatory and autoimmune diseases are excluded from the study, pregnancy and lactation, drug abuse.
Intervention groups
Group A (ellagic acid): daily consumption of two 90 mg capsules made by Exir Gostar Company for 12 weeks. Group B (placebo): A placebo similar to the above cellulose capsules prepared by Exir Gostar Company for 12 weeks.
Main outcome variables
Serum levels of IL4, IL17, IFNγ, TGF-β and expression of T-bet, GATA3 and RORγ genes.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20120415009472N22
Registration date: 2020-12-19, 1399/09/29
Registration timing: prospective

Last update: 2020-12-19, 1399/09/29
Update count: 0
Registration date
2020-12-19, 1399/09/29
Registrant information
Name
Naheed Aryaeian
Name of organization / entity
Iran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8670 4750
Email address
aryaeian.n@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-01-10, 1399/10/21
Expected recruitment end date
2021-08-21, 1400/05/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Ellagic acid supplementation on disease severity, expression of involved genes in pathogenesis, and levels of immunity and inflammatory biomarkers in patients with Multiple Sclerosis
Public title
Ellagic acid in multiple sclerosis
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Patient informed consent Disease diagnosis based on McDonald's criteria and MRI by a neurologist EDSS score less than 5.5 Relapsing-remitting status of the disease age between 18 and 55 years
Exclusion criteria:
Reluctance to participate in the study Take nutritional supplements, antioxidants, and ellagic acid during a month before the start of the study and during the study (except for routine supplements that are part of the treatment plan for all patients, including vitamin D) Taking nonsteroidal anti-inflammatory drugs, estrogen, progesterone, immunosuppressives, diuretics, and corticosteroids during a month before the study Patients with inflammatory bowel disease (IBD), rheumatoid arthritis, systemic lupus erythematosus, type 1 diabetes, and other autoimmune diseases are excluded from the study. Pregnancy and lactation Drug abuse
Age
From 18 years old to 55 years old
Gender
Both
Phase
3
Groups that have been masked
  • Participant
  • Care provider
  • Investigator
  • Outcome assessor
Sample size
Target sample size: 46
Randomization (investigator's opinion)
Randomized
Randomization description
Random allocation will be done with the balanced block method and 4 blocks will be used. Assuming having two groups A and B, by random permutation method, we will have these block modeling: AABB, ABAB, ABBA, BAAB, BBAA, BABA, in which subjects will be placed in these blocks in order of entering in the study and each patient randomly will be assigned in the intervention or control groups.
Blinding (investigator's opinion)
Double blinded
Blinding description
The method of blinding is that the statistical consultant encodes the supplements from 1 to 46 and the researcher, without knowing the type of supplement or placebo, will present the supplements to the subjects from the beginning of the study.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Iran University of Medical Sciences
Street address
Iran University of Medical Sciences, Shahid Hemmat Highway, next to Milad tower.
City
Tehran
Province
Tehran
Postal code
1449614535
Approval date
2020-12-13, 1399/09/23
Ethics committee reference number
IR.IUMS.REC.1399.1000

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
Expanded Disability Status Scale
Timepoint
At the beginning of the study and 12 weeks after supplementation with ellagic acid
Method of measurement
Extensive Disability Scale Questionnaire

Secondary outcomes

1

Description
Interleukin 17
Timepoint
At the beginning of the study and 12 weeks after supplementation with ellagic acid
Method of measurement
Interleukin 17 kit by ELISA method

2

Description
Interleukin 4
Timepoint
At the beginning of the study and 12 weeks after supplementation with ellagic acid
Method of measurement
Interleukin 4 kit by ELISA method

3

Description
Transforming growth factor beta (TGF-β)
Timepoint
At the beginning of the study and 12 weeks after supplementation with ellagic acid
Method of measurement
TGF-β kit by ELISA method

4

Description
Interferon gamma
Timepoint
At the beginning of the study and 12 weeks after supplementation with ellagic acid
Method of measurement
Interferon gamma kit by ELISA method

5

Description
T-bet gene expression
Timepoint
At the beginning of the study and 12 weeks after supplementation with ellagic acid
Method of measurement
Standard quantitative real - time PCR

6

Description
GATA3 gene expression
Timepoint
At the beginning of the study and 12 weeks after supplementation with ellagic acid
Method of measurement
Standard quantitative real - time PCR

7

Description
RORγt gene expression
Timepoint
At the beginning of the study and 12 weeks after supplementation with ellagic acid
Method of measurement
Standard quantitative real - time PCR

Intervention groups

1

Description
Intervention group: Intervention group: The intervention group receives two 90 mg capsules of ellagic acid daily for 12 weeks before lunch and dinner (made by Exir Gostar Company).
Category
Treatment - Other

2

Description
Control group: The placebo group receives two placebo capsules (containing cellulose) in the same color, shape and smell as the ellagic acid supplement daily for 12 weeks before lunch and dinner (made by Exir Gostar).
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Firouzgar hospital
Full name of responsible person
Dr. Naheed Aryaeian
Street address
Iran University of Medical Sciences, Next to Milad Tower, Hemmat Highway.
City
Tehran
Province
Tehran
Postal code
1134845764
Phone
+98 21 8670 4750
Email
nah_arya2002@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Dr. Seyyed Abbas Motevalian
Street address
Iran Univesity of Medical Sciences, Next to Milad Tower, Hemmat Highway.
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 8670 2504
Email
research-m@iums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran 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
Iran University of Medical Sciences
Full name of responsible person
Dr. Naheed Aryaeian
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Iran University of Medical Sciences, Next to Milad Tower, Hemmat Highway.
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 8670 4750
Email
nah_arya2002@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Naheed Aryaeian
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Nutrition department, school of public health, Hemmat broad way
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 8670 4750
Fax
+98 21 8862 2707
Email
n-aryaeian@sina.tums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Naheed Aryaeian
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Nutrition department, school of public health, Hemmat broad way
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 8670 4750
Fax
+98 21 8862 2707
Email
n-aryaeian@sina.tums.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Information on primary and secondary outcomes can be shared at the end of the study.
When the data will become available and for how long
6 months after the publication of the article
To whom data/document is available
All individuals, including researchers who work in university and scientific places, physicians, nutritionists and those engaged in the industry, can use these documentations.
Under which criteria data/document could be used
Use of the documentation is permitted if there is no copyng and no citation or inappropriate citation.
From where data/document is obtainable
Dr. Naheed Aryaeian
What processes are involved for a request to access data/document
Applicants will be able to access the data from the present study by sending an email to the corresponding author within a maximum of one week.
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