The effect of oral administration and topical application of Linum usitatissimum L. (flax seed) oil along with a calorie restricted diet on anthropometric indices, pain, physical function, and serum indices of oxidative stress in patients with knee osteoarthritis
The effect of oral administration and topical application of flax seed oil along with a calorie restricted diet on pain, physical function, and serum indices of oxidative stress in patients with knee osteoarthritis
Design
A parallel-group, double-blind, randomized, phase 3 clinical trial on 88 patients.
Random array subset selection (RASS) was used for randomization.
Settings and conduct
Educational-therapeutic center of Imam Reza and Shohada of Tabriz
After taking the blood samples of the patients and randomly assigning them to one of the groups, the supplements are delivered to the people for use for two weeks.
After completion of the intervention period, the patients will visit Imam Reza Hospital and 5 cc of venous blood sample will be taken from them.
To double-blind the conduct of the research, this will be done by an independent person from the study with using opaque sealed envelopes numbered 1, 2, 3, and 4 to conceal the allocation process.
Subjects, clinical investigators, and the person responsible for statistical analysis will be blinded to the random assignment of subjects until the end of the study.
Participants/Inclusion and exclusion criteria
Adult men and women (over 40 years old)
Intervention groups
The first group receives flax seed oil in addition to topical flax seed oil along with a low calorie diet.
The second group received a placebo of flax seed oil and topical flax seed oil along with a low calorie diet.
The third group received flax seed oil plus topical paraffin oil as a placebo along with a low calorie diet.
The fourth group received placebo flax seed oil and paraffin topical oil as a placebo along with a low calorie diet.
Main outcome variables
Changes in the average physical performance of the subjects based on the total score of the WOMAC index
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20161022030424N10
Registration date:2023-12-29, 1402/10/08
Registration timing:prospective
Last update:2023-12-29, 1402/10/08
Update count:0
Registration date
2023-12-29, 1402/10/08
Registrant information
Name
Neda Dolatkhah
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 41 3336 1928
Email address
dolatkhahn@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-04-18, 1403/01/30
Expected recruitment end date
2024-09-20, 1403/06/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of oral administration and topical application of Linum usitatissimum L. (flax seed) oil along with a calorie restricted diet on anthropometric indices, pain, physical function, and serum indices of oxidative stress in patients with knee osteoarthritis
Public title
The effect of Linum usitatissimum L. (flax seed) oil along with a calorie restricted diet in patients with knee osteoarthritis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Diagnosis of knee osteoarthritis by a physical medicine specialist (mild, moderate) based on the diagnostic criteria of the American College of Rheumatology and the radiological evaluation of knee osteoarthritis by Clairgen Lawrence
Overweight and obese people based on body mass index of 25-40 weight per square meter
Not taking anticoagulants
Absence of knee joint replacement surgery
Absence of fractures involving the surface of the knee joint
Absence of skin diseases in the knee area
Absence of other systemic rheumatic diseases or RA, neuropathy, sensory disturbances due to drug, sedative or tobacco use
Exclusion criteria:
Treatment with oral or intra articular corticosteroids in the past 3 months
Age
From 40 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
88
Randomization (investigator's opinion)
Randomized
Randomization description
A block randomization method will be used to allocate participants to the groups with a 1:1:1:1 allocation using random allocation software (RAS) with block sizes of 4 and 8. Similarly sealed envelopes will be used to conceal the allocation in a sequentially numbered opaque package
Blinding (investigator's opinion)
Double blinded
Blinding description
Flaxseed and placebo food supplements are prepared and presented by Barij Essan Pharmaceutical Company, Kashan, Iran, and there will be no difference in color, shape, or taste between them. Liquid paraffin is packaged in containers similar to Flaxseed oil containers. Blocking and random allocation of the investigated subjects is done by a statistician outside the research team of the project. Outcome assessors, the person responsible for statistical analysis of the data, and the respondents will be blinded to the type of supplement received until the end of the study.
Placebo
Used
Assignment
Factorial
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research ethics committee of Tabriz University of Medical Sciences
Evaluation of physical performance at baseline (before intervention) and 8 weeks after starting the oral and topical supplement of flaxseed oil.
Method of measurement
Western Ontario and McMaster Universities Osteoarthritis Index questionnaire
Secondary outcomes
1
Description
Pain intensity
Timepoint
Measurement of the pain intensity at baseline (before intervention) and 8 weeks after oral and topical supplement of flaxseed oil.
Method of measurement
Visual Analogue Scale
2
Description
Anthropometric indices
Timepoint
Measurement of the anthropometric indices at baseline (before intervention) and 8 weeks after oral and topical supplement of flaxseed oil.
Method of measurement
Seca digital scale
3
Description
Serum concentration of oxidative stress indices (MDA and TAC)
Timepoint
Measurement of the serum levels of inflammatory markers at baseline (before intervention) and 8 weeks after oral and topical supplement of flaxseed oil.
Method of measurement
Biochemical analysis
Intervention groups
1
Description
The first intervention group: was given one flax seed oil (Barij Essential Oil Company, Kashan, Iran) three times a day for 8 weeks, plus topical flax seed oil (Barij Essential Oil Company, Kashan, Iran) 20 drops every 8 hours to rub on the knees along with a low-calorie diet.
Category
Treatment - Drugs
2
Description
The second intervention group: for 8 weeks, they received a placebo of flaxseed oil and topical flaxseed oil (Barij Essan Pharmaceutical Company, Kashan, Iran) three times a day, 20 drops every 8 hours to rub on the knees along with a low-calorie diet.
Category
Treatment - Drugs
3
Description
The third intervention group: For 8 weeks, they will receive one flaxseed oil three times a day (Barij Essence Pharmaceutical Company, Kashan, Iran) plus topical paraffin oil as a placebo to rub on the knees along with a low-calorie diet.
Category
Treatment - Drugs
4
Description
Control group: for 8 weeks, they received a placebo of flaxseed oil and topical paraffin oil as a placebo to rub on the knees three times a day along with a low-calorie diet.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Neda Dolatkhah
Full name of responsible person
Neda Dolatkhah
Street address
Emam Reza hospital, Golgasht Str., Azadi Ave.
City
Tabriz
Province
East Azarbaijan
Postal code
5166614756
Phone
+98 41 3336 1928
Email
neda_dolatkhah@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Parviz Shahabi
Street address
Research Vice Chancellor, Tabriz University of Medical Sciences, Daneshgah Ave.
City
Tabriz
Province
East Azarbaijan
Postal code
5169875841
Phone
+98 41 3335 7310
Email
parvizshahabi@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz 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
Tabriz University of Medical Sciences
Full name of responsible person
Neda Dolatkhah
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Nutrition
Street address
Emam Reza hospital, Golgasht Str., Azadi Ave.
City
Tabriz
Province
East Azarbaijan
Postal code
5163995749
Phone
+98 41 3336 1928
Email
neda_dolatkhah@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Neda Dolatkhah
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Nutrition
Street address
Emam Reza hospital, Golgasht Str., Azadi Ave.
City
Tabriz
Province
East Azarbaijan
Postal code
5163995479
Phone
+98 41 3336 1928
Email
neda_dolatkhah@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Sahar Damirchi
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Physical Medicine
Street address
Emam Reza hospital, Golgasht Str., Azadi Ave.
City
Tabriz
Province
East Azarbaijan
Postal code
5362147895
Phone
+98 41 3336 1928
Email
sahar.dmr96@gmail.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