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.
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Pain, Acute
- Sponsor
- Francisco Javier Martínez Noguera
- Enrollment
- 80
- Locations
- 1
- Primary Endpoint
- Intensity of knee pain
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
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.
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.
Investigators
Francisco Javier Martínez Noguera
PhD (Head of the nutrition area of the Research Center for High Performance Sport)
Universidad Católica San Antonio de Murcia
Eligibility Criteria
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.
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- Weight(The following data will be recorded during the baseline visit)
- Body mass index(The following data will be recorded during the baseline visit)
- Height(The following data will be recorded during the baseline visit)
- Clinical data(The following data will be recorded during the baseline visit)
- Current analgesic medication:(The following data will be recorded during the baseline visit)
- Physical activity data(The following data will be recorded during the baseline visit)
- Demographic data(The following data will be recorded during the baseline visit)
- Frequency of alcohol and tobacco consumption(The following data will be recorded during the baseline visit)
- Sleep quality using the Pittsburgh test(Throughout study completion, an average of 12 weeks)
- Number of participants taking medication(Throughout study completion, an average of 12 weeks)
- Knee range of motion (ROM)(Throughout study completion, an average of 12 weeks)
- Quality of Life Questionnaire SF-36(Throughout study completion, an average of 12 weeks)
- WOMAC scale to measure pain, functional capacity and impact on quality of life(Throughout study completion, an average of 12 weeks)
- KOOS Questionnaire for Knee Assessment(Throughout study completion, an average of 12 weeks)