Pain, AcuteCOLARTNCT05917925
Evaluation of the Effect of a Food Supplement Based on Hydrolyzed Collagen on Joint Function.
A study testing COLLAGEN (COL) in people with Pain, Acute and Pain, Chronic, run by Francisco Javier Martínez Noguera at 1 site in Spain.
Trial summary
This clinical study evaluates the effect of taking a hydrolyzed collagen-based supplement on pain, function and quality of life in a moderately physically active population. Non-pathological knee pain is a common occurrence in many healthy people and can limit the quality of life. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Pain, Acute, Pain, Chronic, Knee Osteoarthritis
- What is being tested?
- COLLAGEN (COL)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteSpain
- Study dates
- 1 Apr 2023to Jun 2024
- 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 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Individuals who exercise regularly and meet the WHO definition of being moderately active.
- Persistent exercise-associated knee pain lasting at least 2 months prior to study inclusion.
- Knee pain score on the visual analogue pain scale of at least 30 mm, taking into account that the scale has a maximum range of 100 mm.
Who cannot join
- Individuals with severe illness.
- Subjects who are taking or have been treated within the last 7 days with glucosamine, chondroitin sulphate, collagen or hyaluronic acid injections or any dietary supplement indicated for joint health.
- Subjects with chronic inflammatory diseases affecting the musculoskeletal apparatus.
- Subjects with obesity (BMI ≥ 30 Kg/m2).
- Allergy or known hypersensitivity to any of the ingredients in the investigational product.
- Phenylketonuria.
Show all 12Show fewer
- Treatment with narcotics, steroidal anti-inflammatory drugs or immunosuppressants. - Symptoms of extreme pain requiring high doses of analgesic therapy for a period of time longer than 2 weeks or intra-articular injection treatment.
- Individuals with diabetes.
- Pregnant women.
- Lactating women.
- Subjects who are participating in a clinical trial.
- Subjects who have participated in a clinical trial for pain in the last month.
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Research Center for High Performance Sport. Catholic University of Murcia
La Ñora, Murcia, 30830
Francisco Javier Martínez Noguera, PhD, 646666782 ext. +34, fjmartinez3@ucam.edu
Cristian Marín Pagán, PhD, 968278566 ext. +34, cmarin@ucam.edu
About this study
Official title: Randomized, Double-blind Clinical Study to Evaluate the Effect of a Food Supplement Based on Hydrolyzed Collagen on Joint Function in a Moderately Active Population.
This clinical study evaluates the effect of taking a hydrolyzed collagen-based supplement on pain, function and quality of life in a moderately physically active population. Non-pathological knee pain is a common occurrence in many healthy people and can limit the quality of life. Therefore, the resolution of this problem can bring many benefits in terms of quality of life.
Read the detailed description
Study design
Randomized, double-blind, placebo-controlled clinical trial with 2 parallel study groups (collagen-based formulation and placebo). Participants will take the study products for 12 weeks.
- Conditions
- Pain, Acute, Pain, Chronic, Knee Osteoarthritis, Knee Injuries
- Being tested
- COLLAGEN (COL), PLACEBO (PLA)
- Keywords
- Hydrolyzed collagen, Post-exercise pain, Supplementation, Inflammation, Quality of life
- Medical subject headings
- Acute Pain, Chronic Pain, Osteoarthritis, Knee, Knee Injuries, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
COLLAGEN (COL)Dietary supplement
The collagen-based supplement will be ingested every day for 12 weeks at the same time.
PLACEBO (PLA)Dietary supplement
The placebo will be ingested every day for 12 weeks at the same time.
| Study group | Role | What they receive |
|---|---|---|
| COLLAGEN (COL) | Experimental | Subjects in this group will intake 10 g/day of a hydrolyzed collagen-based supplement. Receives: Dietary Supplement: COLLAGEN (COL) |
| PLACEBO (PLA) | Placebo comparator | Subjects in this group will intake 10 g/day of placebo (maltodextrin). Receives: Dietary Supplement: PLACEBO (PLA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intensity of knee pain
It will be measured using a 100 mm long horizontal visual analogue scale (VAS) on which the participant must mark the pain he/she feels with 0 being "none" and 100 being "the most intense pain he/she can imagine". Once the level of pain is marked on the horizontal line, the length is measured from 0 in millimetres with a millimetre ruler.
The results will be evaluated according to three levels of pain based on the marked values:
<40 mm: Values below 40 mm indicate mild or mild moderate pain
40-60 mm: If the measurement is between 40 and 60 mm, the pain is considered moderate to moderate-severe
>60 mm: If the values are greater than 60 mm, the pain is considered severe to unbearable.
Measured: Throughout study completion, an average of 12 weeks
Secondary outcomes (14)
Physical activity data
Intensity by applying the IPAQ questionnaire and type (running, cycling, climbing, tennis, football...).
Measured: The following data will be recorded during the baseline visit
Demographic data
Age, sex, employment status (active, unemployed, retired, student ....).
Measured: The following data will be recorded during the baseline visit
Frequency of alcohol and tobacco consumption
Alcohol consumption and tobacco consumption (grams of alcohol and cigarettes per week)
Measured: The following data will be recorded during the baseline visit
Weight
It will be measured by means of a precision balance (kg)
Measured: The following data will be recorded during the baseline visit
Height
It will be measured by means of a stadiometer (cm)
Measured: The following data will be recorded during the baseline visit
Body mass index
It will be calculated by the following formula kg/m2
Measured: The following data will be recorded during the baseline visit
Clinical data
Symptoms are unilateral (Yes/No), Other joint problems (back, hand, neck, feet, shoulder, hip)
Measured: The following data will be recorded during the baseline visit
Current analgesic medication:
Medication that has been taken at least once a week during the previous month. The name or active ingredient of the drug, dosage and frequency should be indicated.
Measured: The following data will be recorded during the baseline visit
Number of participants taking medication
During the study, both the increase or reduction of chronic analgesic medication taken by the participant for pain management and the intake of new rescue medication, which is medication taken occasionally for symptomatic or symptom management, treatment of crises or exacerbations, will be recorded.
Measured: Throughout study completion, an average of 12 weeks
Knee range of motion (ROM)
To assess ROM, the participant will be placed in a prone position on a stretcher. An electrogoniometer will then be placed on the leg to be assessed (affected leg) and the participant will be asked to voluntarily flex as far as possible or until pain is felt.
Measured: Throughout study completion, an average of 12 weeks
WOMAC scale to measure pain, functional capacity and impact on quality of life
The WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index) questionnaire is used to assess participants' perceived clinical changes in knee pain, stiffness and function.
Measured: Throughout study completion, an average of 12 weeks
Quality of Life Questionnaire SF-36
The SF-36 health questionnaire is composed of 36 items that aim to collect all relevant aspects to characterize the health of an individual.
Measured: Throughout study completion, an average of 12 weeks
KOOS Questionnaire for Knee Assessment
The Knee Injury and Osteoarthritis Outcome Score (KOOS) has been developed as an instrument to assess the patient's opinion of their knee and associated problems. The scores for each dimension are calculated by summing the responses to the relevant questions. The resulting scores are transformed into a scale from 0 to 100.
Measured: Throughout study completion, an average of 12 weeks
Sleep quality using the Pittsburgh test
Sleep quality is assessed using the Pittsburgh sleep quality questionnaire. This questionnaire has 19 self-assessment questions and 5 questions addressed to the roommate or bed partner, with only the first 19 being used to obtain the overall score.
Measured: Throughout study completion, an average of 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2023
- Study start1 Apr 2023
- Primary completionFeb 2024 (estimated)
- Study completionJun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain, AcuteStudies 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
- Model description
- A randomized parallel study will be conducted in which 80 subjects will be divided into 2 groups: COL) 10 g/d hydrolyzed collagen-based supplement; PLA) 10 g/d placebo (maltodextrin) for 12 weeks.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Francisco Javier Martínez Noguera
- Sponsor type
- University, hospital or other
- Collaborators
- San Antonio Technologies - San Antonio Catholic University of Murcia
- Responsible party
- Sponsor-investigator, Francisco Javier Martínez Noguera, Universidad Católica San Antonio de Murcia
- Investigators
- Francisco Javier Martínez Noguera, PhD, Study chair, Research Center for High Performance Sport. Catholic University of Murcia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05917925
- Sponsor's protocol ID
- CE012308
- Acronym
- COLART
- Status last verified
- Jul 2023
- First submitted
- 8 May 2023
- Last updated
- 6 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Double-blind Clinical Study to Evaluate the Effect of a Food Supplement Based on Hydrolyzed Collagen on Joint Function in a Moderately Active Population.
- ClinicalTrials.gov ID
- NCT05917925
- Acronym / sponsor ID
- COLART / CE012308
- Conditions
- Pain, Acute, Pain, Chronic, Knee Osteoarthritis, Knee Injuries
- Keywords
- Hydrolyzed collagen, Post-exercise pain, Supplementation, Inflammation, Quality of life
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Francisco Javier Martínez NogueraUniversity, hospital or other
- Collaborators
- San Antonio Technologies - San Antonio Catholic University of Murcia
- Study start
- 1 Apr 2023 (actual)
- Primary completion
- Feb 2024 (estimated)
- Study completion
- Jun 2024 (estimated)
- First posted
- 26 Jun 2023 (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 clinical study evaluates the effect of taking a hydrolyzed collagen-based supplement on pain, function and quality of life in a moderately physically active population. Non-pathological knee pain is a common occurrence in many healthy people and can limit the quality of life. Therefore, the resolution of this problem can bring many benefits in terms of quality of life.
Detailed description
Study design
Randomized, double-blind, placebo-controlled clinical trial with 2 parallel study groups (collagen-based formulation and placebo). Participants will take the study products for 12 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- A randomized parallel study will be conducted in which 80 subjects will be divided into 2 groups: COL) 10 g/d hydrolyzed collagen-based supplement; PLA) 10 g/d placebo (maltodextrin) for 12 weeks.
| Arm | Type | Receives |
|---|---|---|
| COLLAGEN (COL) | Experimental | Dietary Supplement: COLLAGEN (COL)Subjects in this group will intake 10 g/day of a hydrolyzed collagen-based supplement. |
| PLACEBO (PLA) | Placebo comparator | Dietary Supplement: PLACEBO (PLA)Subjects in this group will intake 10 g/day of placebo (maltodextrin). |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Individuals who exercise regularly and meet the WHO definition of being moderately active.
- Persistent exercise-associated knee pain lasting at least 2 months prior to study inclusion.
- Knee pain score on the visual analogue pain scale of at least 30 mm, taking into account that the scale has a maximum range of 100 mm.
Key exclusion criteria (12 listed)
- Individuals with severe illness.
- Subjects who are taking or have been treated within the last 7 days with glucosamine, chondroitin sulphate, collagen or hyaluronic acid injections or any dietary supplement indicated for joint health.
- Subjects with chronic inflammatory diseases affecting the musculoskeletal apparatus.
- Subjects with obesity (BMI ≥ 30 Kg/m2).
- Allergy or known hypersensitivity to any of the ingredients in the investigational product.
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 |
|---|---|---|
| COLLAGEN (COL)The collagen-based supplement will be ingested every day for 12 weeks at the same time. | Dietary supplement | COLLAGEN (COL) |
| PLACEBO (PLA)The placebo will be ingested every day for 12 weeks at the same time. | Dietary supplement | PLACEBO (PLA) |
Primary outcome
Intensity of knee pain
Time frame: Throughout study completion, an average of 12 weeks
It will be measured using a 100 mm long horizontal visual analogue scale (VAS) on which the participant must mark the pain he/she feels with 0 being "none" and 100 being "the most intense pain he/she can imagine". Once the level of pain is marked on the horizontal line, the length is measured from 0 in millimetres with a millimetre ruler. The results will be evaluated according to three levels of pain based on the marked values: <40 mm: Values below 40 mm indicate mild or mild moderate pain 40-60 mm: If the measurement is between 40 and 60 mm, the pain is considered moderate to moderate-severe >60 mm: If the values are greater than 60 mm, the pain is considered severe to unbearable.
14 secondary outcomes
Physical activity data
Time frame: The following data will be recorded during the baseline visit
Demographic data
Time frame: The following data will be recorded during the baseline visit
Frequency of alcohol and tobacco consumption
Time frame: The following data will be recorded during the baseline visit
Weight
Time frame: The following data will be recorded during the baseline visit
Height
Time frame: The following data will be recorded during the baseline visit
Body mass index
Time frame: The following data will be recorded during the baseline visit
Clinical data
Time frame: The following data will be recorded during the baseline visit
Current analgesic medication:
Time frame: The following data will be recorded during the baseline visit
Number of participants taking medication
Time frame: Throughout study completion, an average of 12 weeks
Knee range of motion (ROM)
Time frame: Throughout study completion, an average of 12 weeks
WOMAC scale to measure pain, functional capacity and impact on quality of life
Time frame: Throughout study completion, an average of 12 weeks
Quality of Life Questionnaire SF-36
Time frame: Throughout study completion, an average of 12 weeks
KOOS Questionnaire for Knee Assessment
Time frame: Throughout study completion, an average of 12 weeks
Sleep quality using the Pittsburgh test
Time frame: Throughout study completion, an average of 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2023.
- WebsiteLink provided by the sponsor.
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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.
Francisco Javier Martínez Noguera, PhD study chair
Research Center for High Performance Sport. Catholic University of Murcia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing COLLAGEN (COL) in people with Pain, Acute and Pain, Chronic, run by Francisco Javier Martínez Noguera 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 3 inclusion and 12 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: status not confirmed, as of the sponsor's last update on 6 Jul 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Francisco Javier Martínez Noguera, PhD (968278566 ext. +34, fjmartinez3@ucam.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intensity of knee pain (time frame: Throughout study completion, an average of 12 weeks). 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 6 Jul 2023.