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

Knee Osteoarthritis Clinical Trial

— COLART  

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05917925
• Other study ID #: CE012308
• Status: Recruiting
• Phase: N/A
• Start date: April 1, 2023
• Est. completion date: June 2024

Study information

• Verified date: July 2023
• Source: Universidad Católica San Antonio de Murcia
• Contact: Francisco Javier Martínez Noguera, PhD
• Phone: 968278566
• Email: fjmartinez3[@]ucam.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: June 2024
• Est. primary completion date: February 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Acute Pain
• Chronic Pain
• Knee Injuries
• Knee Osteoarthritis
• Pain, Acute
• Pain, Chronic

Intervention

Dietary Supplement:
• COLLAGEN (COL)
The collagen-based supplement will be ingested every day for 12 weeks at the same time.
• PLACEBO (PLA)
The placebo will be ingested every day for 12 weeks at the same time.

Locations

Country	Name	City	State
Spain	Research Center for High Performance Sport. Catholic University of Murcia	La Ñora	Murcia

Sponsors (2)

Lead Sponsor	Collaborator
Francisco Javier Martínez Noguera	San Antonio Technologies - San Antonio Catholic University of Murcia

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Demographic data	Age, sex, employment status (active, unemployed, retired, student ....).	The following data will be recorded during the baseline visit
Secondary	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
Secondary	Weight	It will be measured by means of a precision balance (kg)	The following data will be recorded during the baseline visit
Secondary	Height	It will be measured by means of a stadiometer (cm)	The following data will be recorded during the baseline visit
Secondary	Body mass index	It will be calculated by the following formula kg/m2	The following data will be recorded during the baseline visit
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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

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