Efficacy Evaluation of Hydrolyzed Collagen Peptide on Knees, Hips, and Ankle Pain in Osteoarthritis

NCT ID: NCT05369780

Last Updated: 2022-05-11

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 160 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-05-15
• Study Completion Date: 2023-05-15

Brief Summary

The aim of this study is to evaluate the effectiveness of Hydrolyzed collagen peptides on joint pain, stiffness and physical function in adults with osteoarthritis who have complaints on knee joints together with hip and ankles. The assessment of improvements on volunteers' quality of life, and safety and tolerability of the product is the other objective of this placebo-controlled, randomized study.

Conditions

Pain, Joint

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: QUADRUPLE

Study Groups

Hydrolized Collagen Peptide

This arm will be allocated randomly and receive 10 g hydrolized collagen peptide (Investigational Product) daily throughout the study.

Group Type: EXPERIMENTAL

Hydrolyzed Collagen Peptide

Intervention Type: DIETARY_SUPPLEMENT

Dietary Hydrolized Collagen Peptide sourced from bovine

Placebo

This arm will be allocated randomly and receive placebo daily throughout the study.

Group Type: PLACEBO_COMPARATOR

Hydrolyzed Collagen Peptide

Intervention Type: DIETARY_SUPPLEMENT

Dietary Hydrolized Collagen Peptide sourced from bovine

Interventions

Hydrolyzed Collagen Peptide

Dietary Hydrolized Collagen Peptide sourced from bovine

Intervention Type: DIETARY_SUPPLEMENT

Other Intervention Names

Collagen

Eligibility Criteria

Inclusion Criteria

1. Male and female individuals with osteoarthritis on knee who are aged between 45-60 years old,

2. Who are not drug-naïve to osteoarthritis and related conditions,

3. Volunteers who have ability to communicate adequately with the investigator and in agreement to comply with the study requirements,

4. Volunteers who have normal blood pressure and heart rate measured under stabilised conditions at the screening visit after at least 5 minutes of rest under supine position: SBP within 100 to 140 mmHg, DBP within 60 to 90 mmHg and HR within 50 to 100 bpm at least after 5 minutes of rest,

5. Volunteers who have understanding of the study and agreement to give a written informed consent.

16. Who have history of difficulty of swallowing.

Exclusion Criteria

1. Who have atopic constitution or asthma and/or known allergy for bovine derived collagen products and/or other any of the excipients of the product.

2. Who have hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucosegalactose malabsorption.

3. Who have an active rheumatoid arthritis or any other inflammatory arthritic condition that researchers consider non appropriate.

4. Who have Diabetes Mellitus.

5. Who have the use of oral retinoids or oral steroids in the 6 months prior to initiation of the study.

6. Who have current participation in another clinical study, or participation in a relevant study within 3 months.

7. Who have any history or presence of serious or life-threatening conditions of cardiovascular, neurological, haematological, hepatic, gastrointestinal, renal, pulmonary, endocrinological, metabolism or psychiatric disease, any type of porphiria.

8. Who have the presence or history of malabsorption or any gastrointestinal surgery except appendectomy or except herniotomy.

9. Who are planned to go or already went under a joint-related reconstructive surgery,

10. For female volunteers, who had undergone, or planned to undergo, pregnancy or breastfeeding.

11. Who have current or regular intake of NSAIDS, contraceptives, hormones, obesity drugs, absorption inhibitors or antidepressants

12. Who are suspected to have a high probability of non-compliance to the study procedure and/or completion of the study according to the investigator's judgment.

13. Who have history of drug abuse.

14. Who have relationship to the investigator.

• Minimum Eligible Age: 45 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Alpan Farma Ar-Ge Biyoteknolojileri Ltd.Sti.

UNKNOWN

Sponsor Role: collaborator

Sel Sanayi Urunleri Ticaret ve Pazarlama A.S.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Central Contacts

Aydın Erenmemişoğlu, Prof. Dr.

Role: CONTACT

aydin@alpanfarma.com

+90 532 551 0082

References

Demir-Dora D, Tuna S, Kurtoglu ED, Gursoy S, Balci N, Tezman S, Erenmemisoglu A. Evaluation of the Efficacy and Safety of CollaSel PRO(R) Type I and Type III Hydrolyzed Collagen Peptides in the Treatment of Osteoarthritis: A Double-Blind, Placebo-Controlled, Randomized Clinical Trial. J Clin Med. 2025 May 23;14(11):3655. doi: 10.3390/jcm14113655.

Reference Type: DERIVED

PMID: 40507417 (View on PubMed)

Other Identifiers

ALP-2021-CL-01-2021/01998

Identifier Type: -

Identifier Source: org_study_id