Clinical Trials Directory

Trials / Completed

CompletedNCT05149053

Hydrolyzed Collagen in the Reduction of Osteoarticular Pain and Functional Limitation

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

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
120 (actual)
Sponsor
Francisco Jose Rodriguez Velasco · Academic / Other
Sex
All
Age
30 Years
Healthy volunteers
Accepted

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

Interventions

TypeNameDescription
DIETARY_SUPPLEMENTHydrolyzed CollagenActive 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.
OTHERPlaceboPlacebo packet contained sucralose (sweetener) and stevia (sweetener) in identical proportions to the active preparation.

Timeline

Start date
2020-06-01
Primary completion
2021-02-26
Completion
2021-03-12
First posted
2021-12-08
Last updated
2021-12-08

Locations

1 site across 1 country: Spain

Source: ClinicalTrials.gov record NCT05149053. Inclusion in this directory is not an endorsement.