Evaluation of the effect oral food product Prepared from chicken feet On anthropometric indicators , Lipid profile, pain reduction, inflammation reduction , And Improving the quality of life On patients with Knee osteoarthritis
Determination of the oral effect of chicken feet on anthropometric indices, lipid profile, pain relief, inflammation reduction and quality of life improvement in patients with knee osteoarthritis
Design
Randomized clinical trial, simple randomization on 50 patients and how to randomize using computer-generated numbers
Settings and conduct
This clinical traial study was performed on 50 patients (25 patients in each group) referred to Motahhari Hospital with osteoarthritis of the knee. At the beginning and end of the study, anthropometric information including height, weight and body mass index and three Food Remembrance Day (two days early in the week and one day in the weekend) is taken from individuals and then the Western Ontario McMaster Universities (WOMAC) and Visual Analogue Scale (VAS) questionnaires are used to assess patients before and after the intervention. Blood samples are also taken before and after 56 days to check for inflammation and blood lipid levels.
Participants/Inclusion and exclusion criteria
People with grade 2 to 4 osteoarthritis who do not have a history of chronic illness, including diabetes, liver disease, psychiatric disorders and other knee-related illnesses, are included in the study.
Intervention groups
Our intervention is burgers made from chicken feet
Main outcome variables
Reduce inflammation, improve quality of life, reduce pain
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20140127016375N2
Registration date:2020-10-10, 1399/07/19
Registration timing:registered_while_recruiting
Last update:2020-10-10, 1399/07/19
Update count:0
Registration date
2020-10-10, 1399/07/19
Registrant information
Name
Siavash Babajafari
Name of organization / entity
School of Nutrition and food sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 1725 7288
Email address
jafaris@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-03-15, 1398/12/25
Expected recruitment end date
2020-11-15, 1399/08/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect oral food product Prepared from chicken feet On anthropometric indicators , Lipid profile, pain reduction, inflammation reduction , And Improving the quality of life On patients with Knee osteoarthritis
Public title
Evaluation of the effect oral food product Prepared from chicken feet On anthropometric indicators , Lipid profile, pain reduction, inflammation reduction , And Improving the quality of life On patients with Knee osteoarthritis
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Men and women in the age group between 30 to 65 years
Non-traumatic knee pain for more than 3 months
Osteoarthritis Limit 2 to 4 Based on the article Introduction - Lawrence Kelgren Daryiography, which has been re-funded in the last 6 months
No history of chronic diseases including diabetes, liver disease, psychiatric disorders
no pregnancy and lactation
Lack of septic arthritis, inflammatory joint disease, gout
No intra-articular injection in either knee during the last 3 months (6 months for hyaluronic acid)
Do not take NSAIDs or alternative therapies for osteoarthritis in the last 15 days and treatment with chondroitin sulfate and glucosamine in the last 3 months
Exclusion criteria:
Failure to follow the study means not consuming more than 80% of the intervention
Acute illness or hospitalization
Age
From 30 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization: In this method, the computer generates numbers between 0 and 1, and if the number is less than 0.5, it is in the intervention group and more than 0.5 in the control group.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
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
ZAND BOUlEVARD
City
SHIRAZ
Province
Fars
Postal code
71348-14336
Approval date
2020-03-15, 1398/12/25
Ethics committee reference number
IR.SUMS.REC.1398.1386
Health conditions studied
1
Description of health condition studied
Osteoarthritis
ICD-10 code
M17.0
ICD-10 code description
Primary gonarthrosis, bilateral
Primary outcomes
1
Description
Improving quality of life in womac questionnaire
Timepoint
At the beginning of the study and the 30th day of the study and the last day of the study
Method of measurement
Womac questionnaire
Secondary outcomes
1
Description
Reduction of inflammation in patients
Timepoint
At the beginning and end of the study
Method of measurement
blood sample
Intervention groups
1
Description
Intervention group: 25 people who have the conditions to study, after randomization, enter the intervention group and are given chicken leg burgers, which should consume a 100-gram burger per day, and also taught them selected exercises to improve knee movements. Necessary examinations will be performed after 8 weeks
Category
Treatment - Other
2
Description
Control group: 25 people who have the conditions to study after randomization enter the control group and they are not given chicken feet burgers and only they are taught selected exercises to improve knee movements. After 8 weeks, the necessary examinations are performed
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
MOTAHHARI HOSPITAL, SHIRAZ
Full name of responsible person
SIAVASH BABA JAFARI
Street address
ZAND BOULEVARD
City
SHIRAZ
Province
Fars
Postal code
71348-14336
Phone
+98 71 3230 5410
Email
moslemaskarpoor@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
YOUNES GHASEMI
Street address
ZAND BOULEVARD
City
SHIRAZ
Province
Fars
Postal code
71348-14336
Phone
+98 71 3230 5410
Email
info@sums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz 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
Shiraz University of Medical Sciences
Full name of responsible person
MOSLEM ASKARPOOR
Position
STUDENT
Latest degree
Bachelor
Other areas of specialty/work
Nutrition
Street address
VALIASR
City
FADAMI
Province
Fars
Postal code
7488134445
Phone
+98 71 5369 2173
Email
moslemaskarpoor@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
moslemaskarpoor
Position
student
Latest degree
Bachelor
Other areas of specialty/work
Nutrition
Street address
valiasr
City
fadami
Province
Fars
Postal code
7488134445
Phone
+98 71 5369 2173
Email
moslemaskarpoor@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
moslem askarpoor
Position
student
Latest degree
Bachelor
Other areas of specialty/work
Nutrition
Street address
valiasr
City
fadami
Province
Fars
Postal code
7488134445
Phone
+98 71 5369 2173
Email
moslemaskarpoor@yahoo.com
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
All personal information of the participants can be shared after identifying them
When the data will become available and for how long
Access starts from 1399 to one year after the results are published
To whom data/document is available
All academics and industry workers
Under which criteria data/document could be used
The right to use is only for themselves and not for others and they are required to include the name of the servant as a colleague
From where data/document is obtainable
Muslim Askarpour by email moslemaskarpoor@uahoo.com
What processes are involved for a request to access data/document
The applicant submits his / her request to the mentioned emails and we provide the information to them