Hydrolyzed Collagen in the Reduction of Osteoarticular Pain and Functional Limitation

NCT ID: NCT05149053

Last Updated: 2021-12-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-06-01
• Study Completion Date: 2021-03-12

Brief 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.

Detailed 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).

Conditions

Osteoarthritis

Keywords

Hydrolyzed Collagen; Osteoarticular Pain; Functional Limitation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Food Supplement

Food supplement packet taken one per day preferably in the morning for 6 months.

Group Type: EXPERIMENTAL

Hydrolyzed Collagen

Intervention Type: DIETARY_SUPPLEMENT

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.

Control

Placebo packet taken one per day preferably in the morning for 6 months.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

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

Interventions

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.

Intervention Type: DIETARY_SUPPLEMENT

Placebo

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

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 30 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

NutraResearch, SL

UNKNOWN

Sponsor Role: collaborator

Francisco Jose Rodriguez Velasco

OTHER

Sponsor Role: lead

Responsible Party

Francisco Jose Rodriguez Velasco

Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

NutraResearch, SL

Barcelona, , Spain

Countries

Spain

Other Identifiers

20/11/2019 CREC

Identifier Type: -

Identifier Source: org_study_id