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

July 4, 2023 updated by: Francisco Javier Martínez Noguera

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.

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 Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Francisco Javier Martínez Noguera, PhD
  • Phone Number: +34 968278566
  • Email: fjmartinez3@ucam.edu

Study Contact Backup

  • Name: Cristian Marín Pagán, PhD
  • Phone Number: +34 968278566
  • Email: cmarin@ucam.edu

Study Locations

  • Spain
    • Murcia
      • La Ñora, Murcia, Spain, 30830
        • Recruiting
        • Research Center for High Performance Sport. Catholic University of Murcia
        • Contact:
          • Cristian Marín Pagán, PhD
          • Phone Number: +34 968278566
          • Email: cmarin@ucam.edu
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: COLLAGEN (COL)
Subjects in this group will intake 10 g/day of a hydrolyzed collagen-based supplement.
Dietary supplement: COLLAGEN (COL)
The collagen-based supplement will be ingested every day for 12 weeks at the same time.
Placebo Comparator: PLACEBO (PLA)
Subjects in this group will intake 10 g/day of placebo (maltodextrin).
Dietary supplement: PLACEBO (PLA)
The placebo will be ingested every day for 12 weeks at the same time.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Throughout study completion, an average of 12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Physical activity data
Time Frame: The following data will be recorded during the baseline visit
Intensity by applying the IPAQ questionnaire and type (running, cycling, climbing, tennis, football...).
The following data will be recorded during the baseline visit
Demographic data
Time Frame: The following data will be recorded during the baseline visit
Age, sex, employment status (active, unemployed, retired, student ....).
The following data will be recorded during the baseline visit
Weight
Time Frame: The following data will be recorded during the baseline visit
It will be measured by means of a precision balance (kg)
The following data will be recorded during the baseline visit
Height
Time Frame: The following data will be recorded during the baseline visit
It will be measured by means of a stadiometer (cm)
The following data will be recorded during the baseline visit
Body mass index
Time Frame: The following data will be recorded during the baseline visit
It will be calculated by the following formula kg/m2
The following data will be recorded during the baseline visit
Clinical data
Time Frame: The following data will be recorded during the baseline visit
Symptoms are unilateral (Yes/No), Other joint problems (back, hand, neck, feet, shoulder, hip)
The following data will be recorded during the baseline visit
Current analgesic medication:
Time Frame: The following data will be recorded during the baseline visit
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
Number of participants taking medication
Time Frame: Throughout study completion, an average of 12 weeks
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
Knee range of motion (ROM)
Time Frame: Throughout study completion, an average of 12 weeks
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
WOMAC scale to measure pain, functional capacity and impact on quality of life
Time Frame: Throughout study completion, an average of 12 weeks
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
Quality of Life Questionnaire SF-36
Time Frame: Throughout study completion, an average of 12 weeks
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
KOOS Questionnaire for Knee Assessment
Time Frame: Throughout study completion, an average of 12 weeks
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
Sleep quality using the Pittsburgh test
Time Frame: Throughout study completion, an average of 12 weeks
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
Frequency of alcohol and tobacco consumption
Time Frame: The following data will be recorded during the baseline visit
Alcohol consumption and tobacco consumption (grams of alcohol and cigarettes per week)
The following data will be recorded during the baseline visit

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Francisco Javier Martínez Noguera

Collaborators

San Antonio Technologies - San Antonio Catholic University of Murcia

Investigators

  • Study Chair: Francisco Javier Martínez Noguera, PhD, Research Center for High Performance Sport. Catholic University of Murcia

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2023

Primary Completion (Estimated)

February 1, 2024

Study Completion (Estimated)

June 1, 2024

Study Registration Dates

First Submitted

May 8, 2023

First Submitted That Met QC Criteria

June 14, 2023

First Posted (Actual)

June 26, 2023

Study Record Updates

Last Update Posted (Actual)

July 6, 2023

Last Update Submitted That Met QC Criteria

July 4, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CE012308

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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