The effect of Ellagic acid on depression, inflammatory index (IFN-ƴ), oxidative (Nrf2) and nitrosative (NO) stress index, Brain Derived Neurotrophic Factor (BDNF), cortisol, serotonin and gene expression of indoleamine dioxygenase enzyme in patients with multiple sclerosis
The aim of this study is to evaluate the effect of Ellagic acid in patients with multiple sclerosis.
Design
12-week randomized, double blinded, parallel clinical trial on 46 patients with multiple sclerosis.
Settings and conduct
Patients are randomly assigned to block randomization in two groups of placebo and supplement. Intervention group received two 90 mg ellagic acid capsules, and the placebo group received two placebo capsules (containing cellulose) in the same color, shape, and odor as the ellagic acid supplement daily for 12 weeks before lunch and dinner. Research process is described for each patient and a written consent form is obtained from all the patients. The 3-day of 24-hour dietary recall is taken at the beginning and end of the study. Patients compliance is monitored by telephone every two weeks. Fasting blood samples are taken from patients at the beginning and end of study. The study protocol has been approved by the ethics committee of Iran University of Medical Sciences.
Participants/Inclusion and exclusion criteria
Willingness
18 -55 years
Depression according to Beck's questionnaire (score above 10)
No change in the dose of antidepressant medication in the last three months
Patients are at recurrence and recovery
EDSS <5.5
Intervention groups
The intervention group received two 90 mg ellagic acid capsules, and the placebo group received two placebo capsules (containing cellulose) in same color, shape, and odor as the ellagic acid supplement daily for 12 weeks before lunch and dinner.
Main outcome variables
Depression Score (Beck Questionnaire); Serum level of IFN-ƴ; Nrf2; NO; BDNF; Cortisol; Serotonin and IDO gene expression and Extensive Disability Severity Score (EDSS)
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20091114002709N54
Registration date:2020-06-07, 1399/03/18
Registration timing:prospective
Last update:2020-06-07, 1399/03/18
Update count:0
Registration date
2020-06-07, 1399/03/18
Registrant information
Name
Farzad Shidfar
Name of organization / entity
Iran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8862 2755
Email address
shidfar.f@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-08-05, 1399/05/15
Expected recruitment end date
2021-11-06, 1400/08/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of Ellagic acid on depression, inflammatory index (IFN-ƴ), oxidative (Nrf2) and nitrosative (NO) stress index, Brain Derived Neurotrophic Factor (BDNF), cortisol, serotonin and gene expression of indoleamine dioxygenase enzyme in patients with multiple sclerosis
Public title
Ellagic acid in multiple sclerosis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Willingness to cooperate
Age range 18 to 55 years
Depression according to Beck's questionnaire (score above 10)
No change in the dose of antidepressant medication in the last three months
Diagnosis of MS by a neurologist
Patients are at recurrence and recovery
EDSS <5.5
Exclusion criteria:
Take nutritional, antioxidant, and ellagic acid supplements for a month before the study (except for routine supplements, which are part of the treatment plan for all patients, such as vitamin D)
Pregnancy and lactation
Drug abuse
History of diabetes and other chronic diseases
History of other autoimmune diseases
Occurrence of recurrence of the disease during study
Taking corticosteroids, estrogens, progesterone, immunosuppressants, diuretics during last month
Dose changes and the type of medication used during study
Change in physical activity
Acceptance rate of less than 90% of supplementation
Lack of willingness to cooperate
Age
From 18 years old to 55 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
46
Randomization (investigator's opinion)
Randomized
Randomization description
Block randomization method has been used for randomization. Blocks size of 4 are generated using www.sealedenvelope.com. In order to conceal the randomization process, individual codes have been on the medicine boxes, which are produced by the software.
Blinding (investigator's opinion)
Double blinded
Blinding description
In order to apply concealment in the randomization process, individual codes will be used on the medicine boxes and the desired code will also be produced by the software.
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
City
Tehran
Province
Tehran
Postal code
1449614535
Approval date
2020-06-01, 1399/03/12
Ethics committee reference number
IR.IUMS.REC.1399.280
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
IFN-ƴ
Timepoint
At the beginning and end of the intervention
Method of measurement
Laboratory kit
Secondary outcomes
1
Description
Depression score
Timepoint
The beginning and the end of the intervention
Method of measurement
Beck questionnaire
2
Description
Nrf2
Timepoint
The beginning and end of the intervention
Method of measurement
Laboratory kit
3
Description
NO
Timepoint
The beginning and end of the intervention
Method of measurement
Laboratory kit
4
Description
BDNF
Timepoint
The beginning and the end of the intervention
Method of measurement
Laboratory kit
5
Description
Cortisol
Timepoint
The beginning and the end of the intervention
Method of measurement
Laboratory kit
6
Description
Serotonin
Timepoint
The beginning and the end of the intervention
Method of measurement
Laboratory kit
7
Description
IDO gene expression
Timepoint
The beginning and end of the intervention
Method of measurement
Real Time RT-PCR
8
Description
EDSS
Timepoint
The beginning and the end of the intervention
Method of measurement
EDSS QUESTIONNAIRE
Intervention groups
1
Description
Intervention group: The intervention group receives two 90 mg allagic acid capsules daily for 12 weeks before lunch and dinner.
Category
Treatment - Other
2
Description
Control group: The placebo group takes two placebo capsules (containing cellulose) in the same color, shape, and odor as the ellagic acid supplement daily for 12 weeks before lunch and dinner.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Rasul Akram Hospital
Full name of responsible person
Farzad Shidfar
Street address
Department of Nutrition, School of Public Health, Iran University of Medical Sciences, Shahid Hemmat Highway
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 86701
Email
farzadshidfar@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Dr. Seyyed Abbas Motevallian
Street address
Iran University of Medical Sciences, Shahid 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
Farzad Shidfar
Position
Full Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Iran University of Medical Sciences, Shahid Hemmat Highway
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 86701
Email
shidfar.f@iums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Farzad Shidfar
Position
Full Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Iran University of Medical Sciences, Shahid Hemmat Highway
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 86701
Email
farzadshidfar@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Farzad Shidfar
Position
Full Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Iran University of Medical Sciences, Shahid Hemmat Highway
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 86701
Email
farzadshidfar@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
There is no further information.
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 the main outcomes at the end of the study can be shared
When the data will become available and for how long
The access period will be 6 months after the publication of the results.
To whom data/document is available
The data from the study will only be available to researchers working at academic and scientific institutions.
Under which criteria data/document could be used
6 months after the publication of the papers of this project, upon request from the corresponding author and his agreement, the data can be made available to researchers.
From where data/document is obtainable
Applicants can contact the corresponding author by email or the following postal address to receive the required data. Nutrition department, School of health, Iran University of Medical Sciences, Hemmat highway, Tehran.
Email: farzadshidfar@yahoo.com
What processes are involved for a request to access data/document
applicants will be able to access the data from the present study no later than one week by sending an email to the corresponding author.