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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
80
The collagen-based supplement will be ingested every day for 12 weeks at the same time.
The placebo will be ingested every day for 12 weeks at the same time.
Research Center for High Performance Sport. Catholic University of Murcia
La Ñora, Murcia, Spain
RECRUITINGIntensity 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.
Time frame: Throughout study completion, an average of 12 weeks
Physical activity data
Intensity by applying the IPAQ questionnaire and type (running, cycling, climbing, tennis, football...).
Time frame: The following data will be recorded during the baseline visit
Demographic data
Age, sex, employment status (active, unemployed, retired, student ....).
Time frame: 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)
Time frame: The following data will be recorded during the baseline visit
Weight
It will be measured by means of a precision balance (kg)
Time frame: The following data will be recorded during the baseline visit
Height
It will be measured by means of a stadiometer (cm)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: The following data will be recorded during the baseline visit
Body mass index
It will be calculated by the following formula kg/m2
Time frame: 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)
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Throughout study completion, an average of 12 weeks