Hydrolyzed Collagen in the Reduction of Osteoarticular Pain and Functional Limitation

NCT05149053 | Completed

• 1 other identifier: 20/11/2019 CREC
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Osteoarthritis

Keywords

Hydrolyzed Collagen; Osteoarticular Pain; Functional Limitation

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (4)

• Change in C-reactive protein (CRP)

  0 and 6 months

• Change in erythrocyte sedimentation rate (ESR)

  0 and 6 months

• Patient satisfaction with treatment

  6 months

• Treatment-emergent adverse effects

  6 months

Study Arms (2)

Food Supplement

EXPERIMENTAL

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

Dietary Supplement: Hydrolyzed Collagen

Control

PLACEBO COMPARATOR

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

Other: Placebo

Interventions

Hydrolyzed Collagen 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.

Food Supplement

Placebo OTHER

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

Control

Eligibility Criteria

• Age: 30 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Francisco Jose Rodriguez Velasco: lead
• NutraResearch, SL: collaborator

Study Sites (1)

NutraResearch, SL

Barcelona, Spain

Location

MeSH Terms

Conditions

Osteoarthritis

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 5, 2021
• First Posted: December 8, 2021
• Study Start: June 1, 2020
• Primary Completion: February 26, 2021
• Study Completion: March 12, 2021
• Last Updated: December 8, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)