Clinical trial NCT05917925: Evaluation of the Effect of a Food Supplement Based on Hydrolyzed Collagen on Joint Function.
Official title: 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.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Pain, Acute
Pain, Chronic
Knee Osteoarthritis
Knee Injuries
Keywords: Hydrolyzed collagen
Post-exercise pain
Supplementation
Inflammation
Quality of life
Lead sponsor: Universidad Católica San Antonio de Murcia
Sponsor class: OTHER
Collaborators: name: San Antonio Technologies - San Antonio Catholic University of Murcia
First posted: 2023-06-26
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

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.

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.
* Subjects who are participating in a clinical trial.
* Subjects who have participated in a clinical trial for pain in the last month.

Primary outcomes:
measure: Intensity of knee pain
timeFrame: Throughout study completion, an average of 12 weeks
Secondary outcomes:
measure: Physical activity data
timeFrame: The following data will be recorded during the baseline visit
measure: Demographic data
timeFrame: The following data will be recorded during the baseline visit
measure: Frequency of alcohol and tobacco consumption
timeFrame: The following data will be recorded during the baseline visit
measure: Weight
timeFrame: The following data will be recorded during the baseline visit
measure: Height
timeFrame: The following data will be recorded during the baseline visit
measure: Body mass index
timeFrame: The following data will be recorded during the baseline visit
measure: Clinical data
timeFrame: The following data will be recorded during the baseline visit
measure: Current analgesic medication:
timeFrame: The following data will be recorded during the baseline visit
measure: Number of participants taking medication
timeFrame: Throughout study completion, an average of 12 weeks
measure: Knee range of motion (ROM)
timeFrame: Throughout study completion, an average of 12 weeks
measure: WOMAC scale to measure pain, functional capacity and impact on quality of life
timeFrame: Throughout study completion, an average of 12 weeks
measure: Quality of Life Questionnaire SF-36
timeFrame: Throughout study completion, an average of 12 weeks
measure: KOOS Questionnaire for Knee Assessment
timeFrame: Throughout study completion, an average of 12 weeks
measure: Sleep quality using the Pittsburgh test
timeFrame: Throughout study completion, an average of 12 weeks
Other outcomes:
Locations:
city: La Ñora
country: Spain
facility: Research Center for High Performance Sport. Catholic University of Murcia
state: Murcia
Study officials:
affiliation: Research Center for High Performance Sport. Catholic University of Murcia
name: Francisco Javier Martínez Noguera, PhD
role: STUDY_CHAIR
References: