Effect of Collagen Supplementation on Tendinopathy

November 1, 2024 updated by: Christian Couppé, Bispebjerg Hospital

Effect of Collagen Supplementation on Tendinopathy in Elite Athletes

Tendon injuries represent a significant problem in elite athletes. Therefore, prevention and effective treatment of tendon overload injury/tendinopathy is important. Among different treatment options, heavy-slow loading based rehabilitation is considered among the most efficient treatments in athletes. In this study, we will investigate if supplementation with hydrolyzed collagen in combination with a heavy-slow loading based 12 weeks rehabilitation regime can improve treatment of tendon overload injury/tendinopathy. The investigators will examine elite athletes with overload injury/tendinopathy with regards to symptoms (pain, function), tendon morphology (ultrasonography), and vascularization (Doppler US). The investigators hypothesize that collagen supplementation can have an improving effect on tendon pain and function. Thus, the investigation will show if a rehabilitation regime of collagen supplementation combined with heavy-slow mechanical loading can improve tendon healing compared to mechanical loading alone.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Randomized placebo-controlled intervention study with follow-up after one month

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
64

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Denmark
      • Copenhagen NV, Denmark, 2400
        • Department of Physical and Occupational Therapy/Institute of Sports Medicine Copenhagen, Bispebjerg Hospital

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years to 36 years (Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Elite athletes
  • 18-40 years old
  • Exercise related tendon pain on one or both legs
  • Soreness during physical examination of tendon upon palpation
  • Uni- or bilateral tendinopathy symptoms > 3 months

Exclusion Criteria:

  • Previous tendon surgery
  • Diabetes
  • Arthritis
  • Corticosteroid injection for tendinopathy within the last 3 months
  • Any form of tendon injection within the last 3 months
  • Smoking

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Collagen + heavy slow resistance group
Daily collagen supplementation + heavy slow resistance training three times weekly for 12 weeks.
Dietary supplement: Hydrolyzed collagen
Hydrolyzed collagen supplementation twice daily
Other: Heavy slow resistance training
Heavy slow resistance training 3 times weekly
Experimental: Placebo + heavy slow resistance group
Daily placebo supplementation + heavy slow resistance training three times weekly for 12 weeks.
Other: Heavy slow resistance training
Heavy slow resistance training 3 times weekly
Dietary supplement: Placebo
Placebo supplementation twice daily

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Maximal tendon pain during the past week at preferred sporting activity
Time Frame: Baseline-12 weeks
Change from baseline - 12 weeks using the Numerical Rating Scale (NRS; 0= no pain, 10 = worst imaginable pain)
Baseline-12 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Maximal tendon pain during the past week at preferred sporting activity
Time Frame: Baseline, 6 weeks + 6 month follow-up
Change from baseline - 6 weeks + 1 month follow-up using the Numerical Rating Scale (NRS; 0= no pain, 10 = worst imaginable pain)
Baseline, 6 weeks + 6 month follow-up
Self-reported activity level of sporting activities (hours/week)
Time Frame: Baseline, 6 and 12 weeks + 6 month follow-up
Participants will self-report how many hours a week they are performing sporting activities: We will monitor to see if they decrease, maintain or increase hours per week of sporting activity
Baseline, 6 and 12 weeks + 6 month follow-up
Single-leg decline squat (SLDS) test
Time Frame: Baseline - 12 weeks
A reliable patellar tendon pain provocation test, will be used to assess pain during function using the Numerical Rating Scale (NRS; 0= no pain, 10 = worst imaginable pain)
Baseline - 12 weeks
Jump test
Time Frame: Baseline - 12 weeks
A reliable Achilles/Plantaris tendon pain provocation test, will be used to assess pain during function using the Numerical Rating Scale (NRS; 0= no pain, 10 = worst imaginable pain)
Baseline - 12 weeks
Adverse events (e.g. allergies, gastro-intestinal side effects) related to supplement ingestion
Time Frame: Baseline - 12 weeks + 6 month follow-up
Participants will self-report adverse events during intervention period and at 6 month follow-up
Baseline - 12 weeks + 6 month follow-up
Change from baseline Victorian Institute of Sports Assessment - Patella/Achilles Questionnaire (VISA-P/A) at 12 wks
Time Frame: Baseline, 6 and 12 weeks + 6 month follow-up
Patient reported outcome regarding symptoms, function and the ability to participate in sports
Baseline, 6 and 12 weeks + 6 month follow-up
Change from baseline Foot function index - Plantaris questionnaire at 12 wks
Time Frame: Baseline, 6 and 12 weeks + 6 month follow-up
Patient reported outcome regarding symptoms, function and the ability to participate in sports
Baseline, 6 and 12 weeks + 6 month follow-up
Tendon thickness measured using Ultrasonography
Time Frame: Baseline - 12 weeks
Baseline - 12 weeks
Pain rating on Numeric Rating Scale (NRS; 0 = no pain; 10 = worst imaginable pain) during training.
Time Frame: Baseline, 6 and 12 weeks + 6 month follow-up
Baseline, 6 and 12 weeks + 6 month follow-up
Treatment satisfaction
Time Frame: 12 weeks
Participants will be asked after the intervention period whether they were satisfied or not with the treatment (dichotomal : Yes vs. No)
12 weeks
Collagen supplement
Time Frame: Baseline - 12 weeks + 6 month follow-up
Participants will be asked on a weekly basis if taken their collagen supplement : Questionnaire (dichotomal : Yes vs. No)
Baseline - 12 weeks + 6 month follow-up
Return-to-sport activities
Time Frame: Baseline - 12 weeks + 6 month follow-up
Participants will self-report Return-to-sport activities during intervention period and at 6 month follow-up (dichotomal : Yes vs. No)
Baseline - 12 weeks + 6 month follow-up
Tendon Doppler activity using Ultrasonography power Doppler
Time Frame: Baseline - 12 weeks
Using Ultrasonography, we will measure Doppler activity within the affected tendon and use the program ImageJ for the analysis
Baseline - 12 weeks

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Bispebjerg Hospital

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
University of Aarhus
Team Denmark

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Christian Couppé, PhD, Institute of Sports Medicine
  • Principal Investigator: Louis Lepetit Thomsen, Institute of Sports Medicine

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 16, 2020

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 1, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 15, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 1, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 8, 2020

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 4, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 1, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • H-16019857

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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