Completed

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

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What is being tested

Hydrolyzed Collagen

+ Placebo

Dietary SupplementOther
Who is being recruted

Arthritis+2

+ Joint Diseases

+ Musculoskeletal Diseases

Over 30 Years
+11 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Placebo-Controlled
Interventional
Study Start: June 2020
See protocol details

Summary

Principal SponsorFrancisco Jose Rodriguez Velasco
Last updated: December 8, 2021
Sourced from a government-validated database.Claim as a partner

Study start date: June 1, 2020

Actual date on which the first participant was enrolled.

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).

Principal SponsorFrancisco Jose Rodriguez Velasco
Last updated: December 8, 2021
Sourced from a government-validated database.Claim as a partner

Protocol

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

120 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 30 Years

Range of ages for which participants are eligible to join.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesOsteoarthritis

Criteria

2 inclusion criteria required to participate
Pain score of at a minimum of 50 mm on a VAS scale of 0-100 mm

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

9 exclusion criteria prevent from participating
Presence of a previous cardiovascular event in the last 6 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.

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

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

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

50% chance of being blinded to the placebo group

Treatment Groups

Group I

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

Group II

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

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

NutraResearch, SL

Barcelona, SpainOpen NutraResearch, SL in Google Maps
CompletedOne Study Center