1. Home
  2. Approved trials
  3. » فارسی

Evaluating the effect of anti-inflammatory diet and flax seed on disease activity, inflammatory factors and quality of life in rheumatoid arthritis patients

Protocol summary

Study aim
Effect of anti-inflammatory diet with flaxseed on inflammatory factors, quality of life and disease activity criteria in people with rheumatoid arthritis
Design
In this double-blind study, we will test the effect of anti-inflammatory diet with this powder on disease activity, inflammatory factors, and quality of life in 120 patients. Patients are randomly divided into control and anti-inflammatory diet groups. At the beginning and at the end of the intervention, SF-36 and HAQ questionnaires will be completed. Finally, statistical analysis will be done using SPSS19 software.
Settings and conduct
Hafez Hospital of Shiraz, informed by patients informed consent, will be given to the intervention group anti-inflammatory training intervention and daily consumption of 30 grams of flaxseed powder using modular are recommended. questionnaires are completed and blood sampling in two stages At the end of the 3-month intervention, healthy control diet and toasted wheat powder will be given to the control group.During the study period, any changes in drug use will be recorded. Diet compliance is assessed weekly by telephone and any problems and side effects will be recorded.
Participants/Inclusion and exclusion criteria
Disease duration of at least 6 months, active disease with DAS28 criterion greater than 2.6 that is clinically established and controlled by the disease and range in age from 18 to 70 years. Individuals will not be included in the study if they have infectious diseases, cancer, and other inflammatory diseases such as liver and kidney failure, adherence to specific diets, drug dependence, alcohol consumption, and repeated use of herbal remedies.
Intervention groups
People with rheumatoid arthritis who are eligible for the study and have been enrolled with consent.
Main outcome variables
Anti-CCP, hs-CRP, hs-CRP, EMS, ESR, DAS28, TJC, ESR, VAS, IL6, rheumatoid factor (RF)

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20190923044858N1
Registration date: 2020-02-06, 1398/11/17
Registration timing: registered_while_recruiting

Last update: 2020-02-06, 1398/11/17
Update count: 0
Registration date
2020-02-06, 1398/11/17
Registrant information
Name
Maryam Ghaseminasabparizi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 3212 2566
Email address
ghaseminasab@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-01-21, 1398/11/01
Expected recruitment end date
2020-05-21, 1399/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluating the effect of anti-inflammatory diet and flax seed on disease activity, inflammatory factors and quality of life in rheumatoid arthritis patients
Public title
Evaluating the effect of anti-inflammatory diet and flax seed on disease activity in rheumatoid arthritis patients
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Disease duration of at least 6 months, active disease with DAS28 criterion greater than 2.6, clinically established and controlled by the drugs and age range 18 to 70 years.
Exclusion criteria:
Individuals will not be included in the study if they have infectious diseases, cancer, and other inflammatory diseases such as liver and kidney failure, adherence to specific diets, drug dependence, alcohol consumption, and repeated use of herbal remedies.
Age
From 18 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Participant
  • Care provider
  • Investigator
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 120
Randomization (investigator's opinion)
Randomized
Randomization description
Patients will be randomly divided into 2 groups (anti-inflammatory regimen with drug administration and control group with usual regimen with drug administration). Statistical software willbe randomization tool.
Blinding (investigator's opinion)
Double blinded
Blinding description
This study is blinded to the use of flaxseed or placebo. Flaxseed and roasted wheat are powdered and packaged by someone other than the researcher and identified by the letters A and B.
Placebo
Used
Assignment
Other
Other design features
-

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Shiraz University of Medical Sciences
Street address
Headquarters of Shiraz University of Medical Sciences, Zand Street, opposite Palestine Street, Shiraz
City
Shiraz
Province
Fars
Postal code
Approval date
2019-10-09, 1398/07/17
Ethics committee reference number
IR.SUMS.REC.1398.892

Health conditions studied

1

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

Primary outcomes

1

Description
Interlukin6
Timepoint
The beginning and the end of the study
Method of measurement
laboratory kit

2

Description
Anti-CCP
Timepoint
The beginning and the end of the study
Method of measurement
laboratory kit

3

Description
DAS28
Timepoint
The beginning and the end of the study
Method of measurement
Through examination

4

Description
Early Morning Stiffness
Timepoint
The beginning and the end of the study
Method of measurement
questionnaire

5

Description
Visual Analogue Scale
Timepoint
The beginning and the end of the study
Method of measurement
questionnaire

6

Description
Erythrocyte Sedimentation Rate
Timepoint
The beginning and the end of the study
Method of measurement
laboratory kit

Secondary outcomes

1

Description
Weight
Timepoint
The beginning and the end of the study
Method of measurement
Digital scales

2

Description
Waist
Timepoint
The beginning and the end of the study
Method of measurement
Tape measure

3

Description
Health Status
Timepoint
The beginning and the end of the study
Method of measurement
Health Status Questionnaire (SF-36)

4

Description
Health assessment
Timepoint
The beginning and the end of the study
Method of measurement
Stanford health assessment questionnaire(HAQ 8-item)

5

Description
3 days food record
Timepoint
The beginning, middle and end of the study
Method of measurement
food record

Intervention groups

1

Description
Intervention group1: Anti-inflammatory diet and flaxseed powder (30 g daily in two 15-g serving) for 3 months of diet and consumption of flaxseed
Category
Treatment - Other

2

Description
Intervention group II: Normal diet and flaxseed powder (30 g daily in two 15 gm serving) for 3 months
Category
Treatment - Other

3

Description
Control group: Normal diet and roasted wheat powder as placebo (30 g daily in two 15 gm serving) for 3 months
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Hafez hospital
Full name of responsible person
Masoumeh Akhlaghi
Street address
School of Nutrition and Food Sciences, Razi Blvd, Shiraz, Iran
City
Shiraz
Province
Fars
Postal code
71348-14336
Phone
+98 71 3230 5410
Email
msm.akhlaghi@gmail.com

Sponsors / Funding sources

1

Sponsor
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
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
Shiraz University of Medical Sciences
Full name of responsible person
Masoumeh Akhlaghi‏
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
School of Nutrition and Food Sciences, Razi Blvd, Shiraz, Iran
City
Shiraz
Province
Fars
Postal code
1433671348
Phone
+98 71 3725 1001
Email
msm.akhlaghi@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Masoumeh Akhlaghi‏
Position
associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
School of Nutrition and Food Sciences, Razi Blvd, Shiraz, Iran
City
Shiraz
Province
Fars
Postal code
1433671348
Phone
+98 71 3725 1001
Email
msm.akhlaghi@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Masoumeh Akhlaghi‏
Position
associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
School of Nutrition and Food Sciences, Razi Blvd, Shiraz, Iran
City
Shiraz
Province
Fars
Postal code
1433671348
Phone
+98 71 3725 1001
Email
msm.akhlaghi@gmail.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
No more information
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Loading...