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

A Multiple-Dose, Randomized, Double-Blinded, Placebo Controlled Trial To Evaluate The Efficacy Of Hydrolyzed Collagen Peptide On Knees, Hips, and Ankle Pains In Adults With Osteoarthritis

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Pain, Joint
• Intervention / Treatment: Dietary supplement: Hydrolyzed Collagen Peptide

• Study Type: Interventional
• Enrollment (Anticipated): 160
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Aydın Erenmemişoğlu, Prof. Dr.; Phone Number: +90 532 551 0082; Email: aydin@alpanfarma.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

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.
15. Who are not suitable to any of inclusion criteria.
16. Who have history of difficulty of swallowing.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Hydrolized Collagen Peptide; This arm will be allocated randomly and receive 10 g hydrolized collagen peptide (Investigational Product) daily throughout the study.	Dietary supplement: Hydrolyzed Collagen Peptide; Dietary Hydrolized Collagen Peptide sourced from bovine; Other Names: Collagen
Placebo Comparator: Placebo; This arm will be allocated randomly and receive placebo daily throughout the study.	Dietary supplement: Hydrolyzed Collagen Peptide; Dietary Hydrolized Collagen Peptide sourced from bovine; Other Names: Collagen

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Amelioration on Knee Pain	Amelioration on knee joint pain, stiffness and physical function according to WOMAC (The Western Ontario and McMaster Universities Osteoarthritis Index) score.	2 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Amelioration on Hip Pain	Amelioration on pain, stiffness and physical function of joints of hip according to WOMAC score.	2 months
Amelioration on Ankle Pain	Amelioration on pain and physical function of ankles according to AOFASAHFS (American Orthopaedic Foot and Ankle Society Ankle-Hindfoot Scale) scale.	2 months

Collaborators and Investigators

• Sponsor: Sel Sanayi Urunleri Ticaret ve Pazarlama A.S.
• Collaborators: Alpan Farma Ar-Ge Biyoteknolojileri Ltd.Sti.

Study record dates

Study Major Dates

• Study Start (Anticipated): May 15, 2022
• Primary Completion (Anticipated): May 15, 2023
• Study Completion (Anticipated): May 15, 2023

Study Registration Dates

• First Submitted: May 6, 2022
• First Submitted That Met QC Criteria: May 6, 2022
• First Posted (Actual): May 11, 2022

Study Record Updates

• Last Update Posted (Actual): May 11, 2022
• Last Update Submitted That Met QC Criteria: May 6, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Arthralgia
• Other Study ID Numbers: ALP-2021-CL-01-2021/01998

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No