OsteoarthritisNCT05149053
Hydrolyzed Collagen in the Reduction of Osteoarticular Pain and Functional Limitation
A study testing Hydrolyzed Collagen in people with Osteoarthritis, run by Francisco Jose Rodriguez Velasco at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 years and olderHealthy volunteers can take part
- Conditions the study is for
- Osteoarthritis
- What is being tested?
- Hydrolyzed Collagen
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteSpain
- Study dates
- 1 Jun 2020to 12 Mar 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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
- Being tested
- Hydrolyzed Collagen, Placebo
- Keywords
- Hydrolyzed Collagen, Osteoarticular Pain, Functional Limitation
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hydrolyzed CollagenDietary 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.
PlaceboOther
Placebo packet contained sucralose (sweetener) and stevia (sweetener) in identical proportions to the active preparation.
| Study group | Role | What they receive |
|---|---|---|
| Food Supplement | Experimental | Food supplement packet taken one per day preferably in the morning for 6 months. Receives: Dietary Supplement: Hydrolyzed Collagen |
| Control | Placebo comparator | Placebo packet taken one per day preferably in the morning for 6 months. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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)
Measured: 0 and 6 months
Secondary outcomes (4)
Change in C-reactive protein (CRP)
Fasting serum levels of C-reactive protein (CRP), assessed by repeated measures analysis at two timepoints ((baseline and end of intervention).
Measured: 0 and 6 months
Change in erythrocyte sedimentation rate (ESR)
Fasting serum levels of erythrocyte sedimentation rate (ESR), assessed by repeated measures analysis at two timepoints ((baseline and end of intervention).
Measured: 0 and 6 months
Patient satisfaction with treatment
Rated with a 3 categories (Good, Poor, Fair), assessed at the end of the intervention.
Measured: 6 months
Treatment-emergent adverse effects
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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2021
- Study start1 Jun 2020
- Primary completion26 Feb 2021
- Study completion12 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteoarthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Francisco Jose Rodriguez Velasco
- Sponsor type
- University, hospital or other
- Collaborators
- NutraResearch, SL
- Responsible party
- Sponsor-investigator, Francisco Jose Rodriguez Velasco, Universidad de Extremadura
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05149053
- Sponsor's protocol ID
- 20/11/2019 CREC
- Status last verified
- Nov 2021
- First submitted
- 5 Nov 2021
- Last updated
- 8 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05149053
- Acronym / sponsor ID
- 20/11/2019 CREC
- Conditions
- Osteoarthritis
- Keywords
- Hydrolyzed Collagen, Osteoarticular Pain, Functional Limitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Francisco Jose Rodriguez VelascoUniversity, hospital or other
- Collaborators
- NutraResearch, SL
- Study start
- 1 Jun 2020 (actual)
- Primary completion
- 26 Feb 2021 (actual)
- Study completion
- 12 Mar 2021 (actual)
- First posted
- 8 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Food Supplement | Experimental | Dietary Supplement: Hydrolyzed CollagenFood supplement packet taken one per day preferably in the morning for 6 months. |
| Control | Placebo comparator | Other: PlaceboPlacebo packet taken one per day preferably in the morning for 6 months. |
Who may qualify
- Ages
- 30 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hydrolyzed 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. | Dietary supplement | Food Supplement |
| PlaceboPlacebo packet contained sucralose (sweetener) and stevia (sweetener) in identical proportions to the active preparation. | Other | Control |
Primary outcome
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).
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)
4 secondary outcomes
Change in C-reactive protein (CRP)
Time frame: 0 and 6 months
Change in erythrocyte sedimentation rate (ESR)
Time frame: 0 and 6 months
Patient satisfaction with treatment
Time frame: 6 months
Treatment-emergent adverse effects
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hydrolyzed Collagen in people with Osteoarthritis, run by Francisco Jose Rodriguez Velasco at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in baseline osteoarticular pain at 6 months (time frame: 0 and 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Dec 2021.