Hydrolyzed Collagen in the Reduction of Osteoarticular Pain and Functional Limitation

Osteoarthritis Clinical Trial

Official title:

Efficacy of Hydrolyzed Collagen as a Food Supplement in the Reduction of Osteoarticular Pain and Functional Limitation: Results From a Randomized, Double-blind, Placebo-Controlled Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05149053
• Other study ID #: 20/11/2019 CREC
• Status: Completed
• Phase: N/A
• Start date: June 1, 2020
• Est. completion date: March 12, 2021

Study information

• Verified date: November 2021
• Source: Universidad de Extremadura
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This randomised study evaluates the efficacy of an oral dietary supplement of Hydrolyzed Collagen in reducing pain and improving physical function in subjects with osteoarthritis.

Description:

In recent years, research efforts have focused on interventions such as collagen supplementation as an alternative treatment for pain and physical function in patients with osteoarthritis. Hydrolyzed collagen (HC) is a mixture of collagen peptides with a molecular weight of less than 5,000 Da. It is obtained from the gelatinization and subsequent enzymatic hydrolysis of native collagen from animal tissues rich in this protein. In this line, several studies show that HC is more easily absorbed enzymatically, has a higher bioavailability, is distributed to joint tissues, and has analgesic and anti-inflammatory properties, consistently showing symptom-relieving effects, thus improving joint function and reducing joint pain, as well as optimizing the patient's quality of life. In this randomized pilot study, the investigators aimed to evaluate the effect on pain and other parameters related to physical function of an oral dietary HC supplement composed of lemon flavoring, anhydrous citric acid (acidifier), calcium ascorbate (vitamin C), sucralose (sweetener) and stevia (sweetener). A 10.728 g dose provides 10 g of HC and 80 mg of vitamin C. Each placebo packet contained sucralose (sweetener) and stevia (sweetener) in identical proportions to the active preparation. Both the active and the placebo were manufactured by NutraResearch© SL (Barcelona, Spain) under Good Manufacturing Practices (GMPs).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: March 12, 2021
• Est. primary completion date: February 26, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 30 Years and older

Eligibility

Inclusion Criteria:

• Diagnosis of osteoarthritis according to the clinical and radiographic criteria of the American College of Rheumatology.

• Pain score of at a minimum of 50 mm on a VAS scale of 0-100 mm

Exclusion Criteria:

• Presence of a previous cardiovascular event in the last 6 months.

• History of liver or kidney disease.

• Presence of medical condition requiring chronic treatment with drugs or other substances.

• Excessive alcohol consumption (> 20 g/day) or substance abuse.

• Presence of intolerance or hypersensitivity to the food supplement or to any of its components in isolation.

• Use of any intra-articular injection in the anatomical area under study in the last 6 months.

• Treatment with symptomatic slow-acting osteoarthritis drugs (SYSADOA) in the last 3 months.

• Criteria listed in the Clinical Investigation Guideline for medicinal products used in the treatment of osteoarthritis published by the European Medicines Agency of the European Union in 2010 and radiographic osteoarthritis grade 4 according to the Kellgren-Lawrence classification system.

• Any condition that, in the opinion of the investigators, would disqualify the subject from participation in the study.

Related Conditions & MeSH terms

• Osteoarthritis

Intervention

Dietary Supplement:
• Hydrolyzed Collagen
Active product was composed of Hydrolyzed Collagen, lemon flavoring, anhydrous citric acid (acidifier), calcium ascorbate (vitamin C), sucralose (sweetener) and stevia (sweetener). One 10.728 g dose provides 10 g of HC and 80 mg of vitamin C.

Other:
• Placebo
Placebo packet contained sucralose (sweetener) and stevia (sweetener) in identical proportions to the active preparation.

Locations

Country	Name	City	State
Spain	NutraResearch, SL	Barcelona

Sponsors (2)

Lead Sponsor	Collaborator
Francisco Jose Rodriguez Velasco	NutraResearch, SL

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in baseline osteoarticular pain at 6 months	Pain level, assessed by Visual Analogue Scale through a repeated measures analysis at two time points (baseline and end of intervention).	0 and 6 months
Primary	Change in baseline functional limitation at 6 months	Functional limitation, assessed by Lesquene Algofunctional Index through a repeated measures analysis at two time points (baseline and end of intervention)	0 and 6 months
Secondary	Change in C-reactive protein (CRP)	Fasting serum levels of C-reactive protein (CRP), assessed by repeated measures analysis at two timepoints ((baseline and end of intervention).	0 and 6 months
Secondary	Change in erythrocyte sedimentation rate (ESR)	Fasting serum levels of erythrocyte sedimentation rate (ESR), assessed by repeated measures analysis at two timepoints ((baseline and end of intervention).	0 and 6 months
Secondary	Patient satisfaction with treatment	Rated with a 3 categories (Good, Poor, Fair), assessed at the end of the intervention.	6 months
Secondary	Treatment-emergent adverse effects	Incidence of adverse effects (type and number) and relatedness to study product (using a 5 category system: certain, likely related, possibly related, conditionally related, unknown), as documented according to the Spanish Medicine and Medical Device Agency (AEMPS) pharmacovigilance system.	6 months