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The effect of astaxanthin supplementation on antioxidant status, inflammation status, disease severity and physical performance in patients with rheumatoid arthritis

Protocol summary

Study aim
Determining the effect of astaxanthin supplementation on antioxidant status, inflammation status, disease severity, and physical performance in patients with rheumatoid arthritis
Design
The clinical trial with a control group, with parallel groups, double-blind, randomized, phase 3 on 60 patients. A table of random numbers is used for randomization
Settings and conduct
The current study is a double-blind, randomized, placebo-controlled clinical trial that will be conducted on adult patients with rheumatoid arthritis. Patients will be randomly divided into 2 groups (30 people) to receive astaxanthin supplement or placebo using a random numbers table. The blood test will e checked and other variables of the study are also examined before and after the intervention (60 days). To know that people are using the capsules ,the empty packages are delivered.
Participants/Inclusion and exclusion criteria
Age between 18 and 65 years old; Rheumatoid arthritis diagnosis by a specialist physician based on criteria (ACR); Having a disease activity score (DAS) higher than 3.2; Willingness to participate in the study and complete the consent form before starting the supplement therapy; Not taking herbal and medicinal supplements, especially antioxidant supplements, in the three months before the start of the study; Having a body mass index of 18.5 to 40
Intervention groups
The astaxanthin supplement and placebo will be delivered to the subjects in 20 mg capsulse, which will be consumed in capsule form along with a specified main meal for 60 days, along with the routine medical treatments prescribed by the doctor
Main outcome variables
Muscle strength; serum level of Interleukin 6 (IL-6); serum level of Malondialdehyde (MDA); Total antioxidant capacity (TAC); Red blood cell sedimentation rate (ESR); CRP serum level; Disease Activity Score (DAS-28); Visual Analogue Scale (VAS); Health Assessment (HAQ)

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20200429047235N2
Registration date: 2024-01-06, 1402/10/16
Registration timing: registered_while_recruiting

Last update: 2024-01-06, 1402/10/16
Update count: 0
Registration date
2024-01-06, 1402/10/16
Registrant information
Name
Marzieh Kafeshani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3792 3169
Email address
kafeshani_nut@yahoo.com
Recruitment status
recruiting
Funding source
Expected recruitment start date
2023-12-22, 1402/10/01
Expected recruitment end date
2025-12-22, 1404/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of astaxanthin supplementation on antioxidant status, inflammation status, disease severity and physical performance in patients with rheumatoid arthritis
Public title
The effect of astaxanthin on rheumatoid arthritis
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Age between 18 and 65 years Rheumatoid arthritis diagnosis by a specialist physician based on criteria (ACR) Having a disease activity score (DAS) higher than 3.2 Willingness to participate in the study and complete the consent form before starting the supplement therapy Not taking herbal and medicinal supplements, especially antioxidant supplements, in the three months before the start of the study Having a body mass index of 18.5 to 40
Exclusion criteria:
Pregnancy and breastfeeding Smoking and being exposed to cigarette smoke on a daily basis Consumption of alcoholic beverages Following a special diet or exercise program Suffering from diseases such as diabetes mellitus, high blood pressure, thyroid disorder, kidney failure, liver dysfunction, Cushing's syndrome Inflammatory bowel diseases (Crohn's and ulcerative colitis) Using traditional medicine methods in the last 3 months Infectious rheumatoid arthritis Having a history of bariatric surgery Consumption of less than 80% of the total astaxanthin food supplement
Age
From 18 years old to 65 years old
Gender
Both
Phase
3
Groups that have been masked
  • Participant
  • Investigator
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Randomized
Randomization description
Patients stratified based on used drugs and BMI then randomly allocated into two groups using permuted random blocks of size 4.
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo and supplement are completely similar in appearance and will be coded by someone other than the researcher so that the researcher is not involved in the grouping process.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Esfahan University of Medical Sciences
Street address
Medical Ethics Department, 1st Floor, Building No. 3, School of Medicine, Isfahan University of Medical Sciences, Hezarjerib Street
City
Esfahan
Province
Isfehan
Postal code
8174673461
Approval date
2023-11-26, 1402/09/05
Ethics committee reference number
IR.MUI.PHANUT.REC.1402.041

Health conditions studied

1

Description of health condition studied
Rheumatoid arthritis
ICD-10 code
M06.9
ICD-10 code description
Rheumatoid arthritis

Primary outcomes

1

Description
antioxidant status
Timepoint
The patient's antioxidant status will be measured at the beginning of the study (before the start of the intervention) and 60 days after the start of the supplement (the end of the intervention).
Method of measurement
Blood tests

2

Description
inflammation status
Timepoint
The measurement of inflammation will be done at the beginning of the study (before the intervention) and 60 days after the start of the supplement (the end of the intervention).
Method of measurement
blood tests

3

Description
Physical performance score
Timepoint
Physical performance will be measured at the beginning of the study (before the start of the intervention) and 60 days after the start of the supplement (the end of the intervention).
Method of measurement
Disease activity score-28 will be used to measure the physical performance score.

4

Description
Illness severity
Timepoint
The severity of the disease will be measured at the beginning of the study (before the start of the intervention) and 60 days after the start of the supplement (the end of the intervention).
Method of measurement
Visual Analogue Scale (VAS) will be used to measure the illness severity.

5

Description
Health evaluation
Timepoint
The patient's health will be evaluated at the beginning of the study (before the start of the intervention) and 60 days after the start of the supplement (the end of the intervention).
Method of measurement
Health Assessment Questionnaire (HAQ) will be used to assess the patient's health.

Secondary outcomes

1

Description
grip strength
Timepoint
Muscle strength will be measured at the beginning of the study (before the start of the intervention) and 60 days after the start of the supplement (the end of the intervention).
Method of measurement
Hand grip will be used to measure grip strength.

2

Description
C reactive protein (CRP)
Timepoint
The serum level of C-reactive protein will be measured at the beginning of the study (before the start of the intervention) and 60 days after the start of the supplement (the end of the intervention).
Method of measurement
Blood test

3

Description
Red blood cell sedimentation rate
Timepoint
Red blood cell sedimentation rate will be measured at the beginning of the study (before the start of the intervention) and 60 days after the start of the supplement (the end of the intervention).
Method of measurement
Blood test

4

Description
Interleukin 6 serum level
Timepoint
Interleukin-6 serum levels will be measured at the beginning of the study (before the intervention) and 60 days after the start of the supplement (the end of the intervention).
Method of measurement
Blood test

5

Description
Malondialdehyde serum level
Timepoint
The measurement of serum malondialdehyde level will be done at the beginning of the study (before the start of the intervention) and 60 days after the start of taking the supplement (the end of the intervention).
Method of measurement
Blood test

6

Description
Total antioxidant capacity (TAC)
Timepoint
Total antioxidant capacity will be measured at the beginning of the study (before the start of the intervention) and 60 days after the start of the supplement (the end of the intervention).
Method of measurement
Blood test

Intervention groups

1

Description
Intervention group: Astaxanthin is a natural carotenoid from the xanthophyll group, which exists in different amounts in different marine organisms such as algae, shrimp, crab, yeast, and salmon. Its main role is to create a desirable orange-red color in these organisms. Also, astaxanthin is a strong biological antioxidant and has the ability to inhibit free radicals. Individuals in the intervention group will receive a daily astaxanthin capsule made by the "Life Refreshing Biotechnology" company located in Al-Zahra University after lunch. By reviewing the relevant articles and the safe amount of astaxanthin consumption, the appropriate dose for astaxanthin supplement based on previous studies will be 20 mg per day in the form of oral capsules.
Category
Treatment - Drugs

2

Description
Control group: The placebo is prepared from Foodchem company and it is made in capsule form and distributed to the patients. The placebo is maltodextrin powder (corn starch) and is completely safe in terms of health.
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Rheumatology doctor's office
Full name of responsible person
Ani Grigorian
Street address
4th floor, Sepahan 2 building, Sepahan Alley, Amadegah St
City
Esfahan
Province
Isfehan
Postal code
8134888961
Phone
+98 31 3220 0477
Email
aniii.gr@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Gholamreza Askari
Street address
Vice Chancellor of University Research and Technology, Building No. 4, Isfahan University of Medical science, Hezarjerib St
City
esfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 3061
Email
aniii.gr@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan 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
Esfahan University of Medical Sciences
Full name of responsible person
Marzieh Kafeshani
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Clinical nutrition Department, 1th Floor, Faculty of Nutrition and Food Sciences, Isfahan University of Medical science, Hezarjerib St
City
Esfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 3169
Email
kafeshani_nut@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Marzieh Kafeshani
Position
Associate professor
Latest degree
Medical doctor
Other areas of specialty/work
Nutrition
Street address
Clinical nutrition Department, 1th Floor, Faculty of Nutrition and Food Sciences, Isfahan University of Medical science, Hezarjerib St
City
Esfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 3169
Email
kafeshani_nut@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Ani Grigorian
Position
student
Latest degree
Bachelor
Other areas of specialty/work
Nutrition
Street address
1st Floor, NO. 5, 1st Bldg., old blocks complex, Khaje Petros, Khaghani St.,
City
Esfahan
Province
Isfehan
Postal code
8175763115
Phone
+98 21 7741 0460
Email
aniii.gr@yahoo.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
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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