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Effect of supplementation with type I and type III collagen peptide and type II hydrolyzed collagen on osteoarthritis-related pain, quality of life and physical function: a randomized, double-blind, placebo-controlled study

Protocol summary

Study aim
To evaluate the effects of 8-week use of Naturagen® 4 Joint product containing type I, II and III collagen on pain, quality of life, balance scales and functional test results in osteoarthritis (OA) patients
Design
This study was designed as a randomized, double-blind, placebo-controlled study. 31 male and female subjects aged 35-65 years with osteoarthritis (OA) participated in the study. Various scales and tests were administered as a pre-test and then subjects were randomized into two groups. After 8 weeks of product use, post-tests were performed. After the tests, within-group and between-group comparisons were made and the effects of the product were analyzed.
Settings and conduct
All measurements in the study were performed in the same performance laboratory. Blinding of the products was done using blinding codes on sealed envelopes. Participants and the researchers responsible for data collection were blinded to treatment allocation.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Diagnosed with Kellgren-Lawrence (KL) grade 2 or 3 knee osteoarthritis (OA) for more than 3 months, Non-vegetarian, Willing to participate in all scheduled visits and tests. Exclusion criteria: Diagnosed with KL grade 1 or 4 knee OA, History of trauma, fracture or surgery at the index joint, Anticipated knee arthroscopy or arthroplasty or life-threatening pathology, Received intra-articular injections or corticosteroids into the target knee joint within the last 6 months
Intervention groups
31 male and female subjects aged 35-65 years with osteoarthritis (OA) participated in the study. After completion of pre-tests, participants were randomized to one of two treatment groups using computer-approved software and divided into collagen (n=16) and placebo (n=15) groups.
Main outcome variables
Pain, quality of life and balance scale scores and various functional test results.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20240411061470N1
Registration date: 2024-04-15, 1403/01/27
Registration timing: retrospective

Last update: 2024-04-15, 1403/01/27
Update count: 0
Registration date
2024-04-15, 1403/01/27
Registrant information
Name
Ali Kerim Yılmaz
Name of organization / entity
Ondokuz Mayıs University, Faculty of Yasar Doğu Sport Sciences
Country
Turkey
Phone
+90 362 457 76 00
Email address
akerim.yilmaz@omu.edu.tr
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-12-04, 1402/09/13
Expected recruitment end date
2023-12-15, 1402/09/24
Actual recruitment start date
2023-12-04, 1402/09/13
Actual recruitment end date
2023-12-15, 1402/09/24
Trial completion date
2024-02-15, 1402/11/26
Scientific title
Effect of supplementation with type I and type III collagen peptide and type II hydrolyzed collagen on osteoarthritis-related pain, quality of life and physical function: a randomized, double-blind, placebo-controlled study
Public title
The effect of collagen-containing supplementation on pain, quality of life and functional parameters in osteoarthritis patients
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Diagnosed with unilateral or bilateral Kellgren and Lawrence radiographic grade 2 or 3 knee OA for more than 3 months Non-vegetarian Willing to participate in all scheduled visits and tests
Exclusion criteria:
Kellgren and Lawrence diagnosed with radiographic grade 1 or 4 knee OA Any history of trauma, fracture or surgery on the index joint Evidence or history of clinically significant hematologic, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, neurologic diseases or malignancies within the last 5 years History of hypersensitivity to the rescue medication or any of the products used in the study Active viral or bacterial infection according to clinical examination Expected knee arthroscopy or arthroplasty or life-threatening pathology Received intra-articular injections or corticosteroids in the target knee joint (the most painful knee at screening) within the last 6 months Patients with intolerance to protein-based foods or supplements, pregnant or breastfeeding women and those with alcohol dependence
Age
From 35 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Participant
  • Investigator
Sample size
Target sample size: 40
Actual sample size reached: 31
Randomization (investigator's opinion)
Randomized
Randomization description
After completion of the pre-tests, participants were randomized to one of the two treatment groups using computer validated software (www.random.org) and divided into collagen (n=16) and placebo (n=15) groups.
Blinding (investigator's opinion)
Double blinded
Blinding description
Blinding of the products was done using blinding codes in sealed envelopes. Participants and the researchers responsible for data collection were blinded to treatment allocation.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Sinop University The Human Research Ethics Committee
Street address
Korucuk District, Trafo Street, No:35, 15 Temmuz Campus, 57000, Sinop
City
Sinop
Postal code
5700
Approval date
2023-09-08, 1402/06/17
Ethics committee reference number
2023/183

Health conditions studied

1

Description of health condition studied
Knee osteoarthritis
ICD-10 code
M17.10
ICD-10 code description
Unilateral primary osteoarthritis, unspecified knee

Primary outcomes

1

Description
Pain Assessment
Timepoint
Pre-intervention and after 8 weeks of intervention
Method of measurement
Western Ontario and McMaster Universities Osteoarthrtis Index (WOMAC), Visual Analogue Scale (VAS)

2

Description
Quality of Life Assessment
Timepoint
Pre-intervention and after 8 weeks of intervention
Method of measurement
Knee Injury and Osteoarthritis Outcome Score Physical Function Short Form (KOOS-PS), Oxford Knee Score (OKS), Tampa Scale for Kinesiophobia (TSK), Short Form Health Survey (SF-12), Foot Function Index (FFI)

3

Description
Balance Assessment
Timepoint
Pre-intervention and after 8 weeks of intervention
Method of measurement
Berg Balance Scale (BBS)

4

Description
Functional Performance Assessment
Timepoint
Pre-intervention and after 8 weeks of intervention
Method of measurement
Timed Up and Go (TUG), 6-Minute Walking Test (6MWT), The Five Repetition Sit to Stand Test (5STS), Stair-Climbing Test (SCT)

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Participants used one sachet of Naturagen® 4 Joint product daily for 8 weeks.
Category
Treatment - Other

2

Description
Control group: Participants used a placebo product with the same appearance, taste and consistency as the Naturagen® 4 Joint product, one sachet a day for 8 weeks.
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Ondokuz Mayıs University
Full name of responsible person
Ali Kerim Yılmaz
Street address
Ondokuz Mayıs University, Samsun, Türkiye
City
Samsun
Postal code
55070
Phone
+90 542 495 37 37
Email
akerim.yilmaz@omu.edu.tr

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Ondokuz Mayıs University
Full name of responsible person
Ali Kerim Yılmaz
Street address
Ondokuz Mayıs University, Samsun, Türkiye
City
Samsun
Postal code
55070
Phone
+90 542 495 37 37
Email
akerim.yilmaz@omu.edu.tr
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ondokuz Mayıs University
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
Ondokuz Mayıs University
Full name of responsible person
Ali Kerim Yılmaz
Position
Assoc. Prof.
Latest degree
Ph.D.
Other areas of specialty/work
Sport Medicine
Street address
Ondokuz Mayıs University, Faculty of Yaşar Doğu Sport Sciences, Samsun, Türkiye
City
Samsun
Province
Samsun
Postal code
55070
Phone
+90 542 495 37 37
Email
akerim.yilmaz@omu.edu.tr

Person responsible for scientific inquiries

Contact
Name of organization / entity
Ondokuz Mayıs University, Faculty of Yasar Doğu Sport Sciences
Full name of responsible person
Ali Kerim Yılmaz
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Sport Medicine
Street address
Ondokuz Mayıs University, Faculty of Yasar Doğu Sport Sciences, Samsun 55270, Türkiye
City
Samsun
Province
Samsun
Postal code
55070
Phone
+90 362 457 76 00
Fax
Email
akerim.yilmaz@omu.edu.tr

Person responsible for updating data

Contact
Name of organization / entity
Ondokuz Mayıs University, Faculty of Yasar Doğu Sport Sciences
Full name of responsible person
Ali Kerim Yılmaz
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Sport Medicine
Street address
Ondokuz Mayıs University, Faculty of Yasar Doğu Sport Sciences, Samsun 55270, Türkiye
City
Samsun
Province
Samsun
Postal code
55070
Phone
+90 362 457 76 00
Fax
Email
akerim.yilmaz@omu.edu.tr

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
To share the data and documents of this research, only the information related to the main outcome will be shared. Also, files that can be published and do not violate people's privacy will be published.
When the data will become available and for how long
The access period will start 6 months after the results are published.
To whom data/document is available
Our data will only be available to researchers working in academic and scientific institutions.
Under which criteria data/document could be used
If there are conditions, all our data will be shared except personal information of people. The use of our data will only be allowed for similar research and review of our data by other researchers. All those who work in universities and scientific centers and decide to conduct similar research or check the accuracy of our data can access our data
From where data/document is obtainable
In order to receive information, all eligible people can collect data by referring to the person in charge of the project. The contact method is the email address akerim.yilmaz@omu.edu.tr.
What processes are involved for a request to access data/document
To receive information after sending the request, the requests will be reviewed within 10 days. If the above conditions are met, the information will be sent to the provided email within 30 days at most.
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