Hydrolyzed Collagen in the Reduction of Osteoarticular Pain and Functional Limitation

November 25, 2021 updated by: Francisco Jose Rodriguez Velasco

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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).

Study Type

Interventional

Enrollment (Actual)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Barcelona, Spain
        • NutraResearch, SL

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Food Supplement
Food supplement packet taken one per day preferably in the morning for 6 months.
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.
Placebo Comparator: Control
Placebo packet taken one per day preferably in the morning for 6 months.
Other: Placebo
Placebo packet contained sucralose (sweetener) and stevia (sweetener) in identical proportions to the active preparation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in baseline osteoarticular pain at 6 months
Time Frame: 0 and 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
Change in baseline functional limitation at 6 months
Time Frame: 0 and 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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in C-reactive protein (CRP)
Time Frame: 0 and 6 months
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
Change in erythrocyte sedimentation rate (ESR)
Time Frame: 0 and 6 months
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
Patient satisfaction with treatment
Time Frame: 6 months
Rated with a 3 categories (Good, Poor, Fair), assessed at the end of the intervention.
6 months
Treatment-emergent adverse effects
Time Frame: 6 months
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Francisco Jose Rodriguez Velasco

Collaborators

NutraResearch, SL

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2020

Primary Completion (Actual)

February 26, 2021

Study Completion (Actual)

March 12, 2021

Study Registration Dates

First Submitted

November 5, 2021

First Submitted That Met QC Criteria

November 25, 2021

First Posted (Actual)

December 8, 2021

Study Record Updates

Last Update Posted (Actual)

December 8, 2021

Last Update Submitted That Met QC Criteria

November 25, 2021

Last Verified

November 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20/11/2019 CREC

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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