COLART: Evaluation of the Effect of a Food Supplement Based on Hydrolyzed Collagen on Joint Function.
Study Details
Study Description
Brief 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. Therefore, the resolution of this problem can bring many benefits in terms of quality of life.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: COLLAGEN (COL) Subjects in this group will intake 10 g/day of a hydrolyzed collagen-based supplement. |
Dietary Supplement: COLLAGEN (COL)
The collagen-based supplement will be ingested every day for 12 weeks at the same time.
|
| Placebo Comparator: PLACEBO (PLA) Subjects in this group will intake 10 g/day of placebo (maltodextrin). |
Dietary Supplement: PLACEBO (PLA)
The placebo will be ingested every day for 12 weeks at the same time.
|
Outcome Measures
Primary Outcome Measures
- Intensity of knee pain [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.
Secondary Outcome Measures
- Physical activity data [The following data will be recorded during the baseline visit]
Intensity by applying the IPAQ questionnaire and type (running, cycling, climbing, tennis, football...).
- Demographic data [The following data will be recorded during the baseline visit]
Age, sex, employment status (active, unemployed, retired, student ....).
- Consumption habits data [The following data will be recorded during the baseline visit]
Alcohol consumption and tobacco consumption
- Weight [The following data will be recorded during the baseline visit]
It will be measured by means of a precision balance (kg)
- Height [The following data will be recorded during the baseline visit]
It will be measured by means of a stadiometer (cm)
- Body mass index [The following data will be recorded during the baseline visit]
It will be calculated by the following formula kg/m2
- Clinical data [The following data will be recorded during the baseline visit]
Symptoms are unilateral (Yes/No), Other joint problems (back, hand, neck, feet, shoulder, hip)
- Current analgesic medication: [The following data will be recorded during the baseline visit]
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.
- Number of participants taking medication [Throughout study completion, an average of 12 weeks]
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.
- Knee range of motion (ROM) [Throughout study completion, an average of 12 weeks]
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.
- WOMAC scale to measure pain, functional capacity and impact on quality of life [Throughout study completion, an average of 12 weeks]
The WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index) questionnaire is used to assess participants' perceived clinical changes in knee pain, stiffness and function.
- Quality of Life Questionnaire SF-36 [Throughout study completion, an average of 12 weeks]
The SF-36 health questionnaire is composed of 36 items that aim to collect all relevant aspects to characterize the health of an individual.
- KOOS Questionnaire for Knee Assessment [Throughout study completion, an average of 12 weeks]
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.
- Sleep quality using the Pittsburgh test [Throughout study completion, an average of 12 weeks]
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.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Individuals who exercise regularly and meet the WHO definition of being moderately active.
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Persistent exercise-associated knee pain lasting at least 2 months prior to study inclusion.
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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.
Exclusion Criteria:
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Individuals with severe illness.
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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.
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Subjects with chronic inflammatory diseases affecting the musculoskeletal apparatus.
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Subjects with obesity (BMI ≥ 30 Kg/m2).
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Allergy or known hypersensitivity to any of the ingredients in the investigational product.
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Phenylketonuria.
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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.
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Individuals with diabetes.
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Pregnant women.
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Lactating women.
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Subjects who are participating in a clinical trial.
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Subjects who have participated in a clinical trial for pain in the last month.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Research Center for High Performance Sport. Catholic University of Murcia | La Ñora | Murcia | Spain | 30830 |
Sponsors and Collaborators
- Francisco Javier Martínez Noguera
- San Antonio Technologies - San Antonio Catholic University of Murcia
Investigators
- Study Chair: Francisco Javier Martínez Noguera, PhD, Research Center for High Performance Sport. Catholic University of Murcia
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.- CE012308