Evaluation of the Effect of a Food Supplement Based on Hydrolyzed Collagen on Joint Function. - Clinical Trial for Pain, Acute | NCT05917925

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Primary Purpose

Status

Recruiting

Phase

Not Applicable

Locations

Spain

Study Type

Interventional

Intervention

COLLAGEN (COL)

PLACEBO (PLA)

About this trial

This is an interventional treatment trial for Pain, Acute focused on measuring Hydrolyzed collagen, Post-exercise pain, Supplementation, Inflammation, Quality of life

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

Research Center for High Performance Sport. Catholic University of MurciaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

COLLAGEN (COL)

PLACEBO (PLA)

Arm Description

Subjects in this group will intake 10 g/day of a hydrolyzed collagen-based supplement.

Subjects in this group will intake 10 g/day of placebo (maltodextrin).

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Physical activity data

Intensity by applying the IPAQ questionnaire and type (running, cycling, climbing, tennis, football...).

Demographic data

Age, sex, employment status (active, unemployed, retired, student ....).

Frequency of alcohol and tobacco consumption

Alcohol consumption and tobacco consumption (grams of alcohol and cigarettes per week)

Weight

It will be measured by means of a precision balance (kg)

Height

It will be measured by means of a stadiometer (cm)

Body mass index

It will be calculated by the following formula kg/m2

Clinical data

Symptoms are unilateral (Yes/No), Other joint problems (back, hand, neck, feet, shoulder, hip)

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.

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.

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.

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.

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.

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.

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.

Full Information

NCT ID

NCT05917925

First Posted

May 8, 2023

Last Updated

July 4, 2023

Sponsor

Francisco Javier Martínez Noguera

Collaborators

San Antonio Technologies - San Antonio Catholic University of Murcia

1. Study Identification

Unique Protocol Identification Number

NCT05917925

Brief Title

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

Acronym

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.

Study Type

Interventional

2. Study Status

Record Verification Date

July 2023

Overall Recruitment Status

Recruiting

Study Start Date

April 1, 2023 (Actual)

Primary Completion Date

February 2024 (Anticipated)

Study Completion Date

June 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Francisco Javier Martínez Noguera

Collaborators

San Antonio Technologies - San Antonio Catholic University of Murcia

4. Oversight

Studies a U.S. FDA-regulated Drug Product

No

Studies a U.S. FDA-regulated Device Product

No

Product Manufactured in and Exported from the U.S.

No

Data Monitoring Committee

No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

Keywords

Hydrolyzed collagen, Post-exercise pain, Supplementation, Inflammation, Quality of life

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

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

ParticipantInvestigatorOutcomes Assessor

Masking Description

triple-blind

Allocation

Randomized

Enrollment

80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

COLLAGEN (COL)

Arm Type

Experimental

Arm Description

Subjects in this group will intake 10 g/day of a hydrolyzed collagen-based supplement.

Arm Title

PLACEBO (PLA)

Arm Type

Placebo Comparator

Arm Description

Subjects in this group will intake 10 g/day of placebo (maltodextrin).

Intervention Type

Dietary Supplement

Intervention Name(s)

COLLAGEN (COL)

Intervention Description

The collagen-based supplement will be ingested every day for 12 weeks at the same time.

Intervention Type

Dietary Supplement

Intervention Name(s)

PLACEBO (PLA)

Intervention Description

The placebo will be ingested every day for 12 weeks at the same time.

Primary Outcome Measure Information:

Title

Intensity of knee pain

Description

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

Secondary Outcome Measure Information:

Title

Physical activity data

Description

Intensity by applying the IPAQ questionnaire and type (running, cycling, climbing, tennis, football...).

Time Frame