Evaluation of the Effect of a Food Supplement Based on Hydrolyzed Collagen on Joint Function.

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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.

Conditions
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Pain, Acute, Pain, Chronic, Knee Osteoarthritis, Knee Injuries

Intervention / Treatment
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* Dietary Supplement: COLLAGEN (COL)
* Dietary Supplement: PLACEBO (PLA)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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. 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: COLLAGEN (COL)<br>Subjects in this group will intake 10 g/day of a hydrolyzed collagen-based supplement. | Dietary Supplement: COLLAGEN (COL)<br>* The collagen-based supplement will be ingested every day for 12 weeks at the same time.<br>|
| Placebo Comparator: PLACEBO (PLA)<br>Subjects in this group will intake 10 g/day of placebo (maltodextrin). | Dietary Supplement: PLACEBO (PLA)<br>* The placebo will be ingested every day for 12 weeks at the same time.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hydrolyzed collagen, Post-exercise pain, Supplementation, Inflammation, Quality of life