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| Name | Class |
|---|---|
| San Antonio Technologies - San Antonio Catholic University of Murcia | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| COLLAGEN (COL) | Experimental | Subjects in this group will intake 10 g/day of a hydrolyzed collagen-based supplement. |
|
| PLACEBO (PLA) | Placebo Comparator | Subjects in this group will intake 10 g/day of placebo (maltodextrin). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| COLLAGEN (COL) | Dietary Supplement | The collagen-based supplement will be ingested every day for 12 weeks at the same time. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Throughout study completion, an average of 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Physical activity data | Intensity by applying the IPAQ questionnaire and type (running, cycling, climbing, tennis, football...). | The following data will be recorded during the baseline visit |
| Demographic data |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Francisco Javier Martínez Noguera, PhD | Contact | 968278566 | +34 | fjmartinez3@ucam.edu |
| Cristian Marín Pagán, PhD | Contact | 968278566 | +34 | cmarin@ucam.edu |
| Name | Affiliation | Role |
|---|---|---|
| Francisco Javier Martínez Noguera, PhD | Research Center for High Performance Sport. Catholic University of Murcia | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Center for High Performance Sport. Catholic University of Murcia | Recruiting | La Ñora | Murcia | 30830 | Spain |
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| ID | Term |
|---|---|
| D059787 | Acute Pain |
| D059350 | Chronic Pain |
| D020370 | Osteoarthritis, Knee |
| D007718 | Knee Injuries |
| D007249 | Inflammation |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D003094 | Collagen |
| ID | Term |
|---|---|
| D001704 | Biopolymers |
| D011108 | Polymers |
| D046911 | Macromolecular Substances |
| D016326 | Extracellular Matrix Proteins |
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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.
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triple-blind
| PLACEBO (PLA) | Dietary Supplement | The placebo will be ingested every day for 12 weeks at the same time. |
|
Age, sex, employment status (active, unemployed, retired, student ....).
| 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) | The following data will be recorded during the baseline visit |
| Weight | It will be measured by means of a precision balance (kg) | The following data will be recorded during the baseline visit |
| Height | It will be measured by means of a stadiometer (cm) | The following data will be recorded during the baseline visit |
| Body mass index | It will be calculated by the following formula kg/m2 | 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) | 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. | 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. | 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. | 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. | 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. | 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. | 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. | Throughout study completion, an average of 12 weeks |
| D010003 | Osteoarthritis |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D007869 | Leg Injuries |
| D014947 | Wounds and Injuries |
| D010335 | Pathologic Processes |
| D012596 |
| Scleroproteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |