Healthy ParticipantsNCT06372080
Resistance Training and Hydrolyzed Collagen Supplementation in Healthy Young Adults
A study testing Resistance training with hydrolyzed collagen ingestion in healthy young men and Resistance training with hydrolyzed collagen ingestion in healthy young women in people with Healthy Participants and Nutrition, run by Liverpool John Moores University at 1 site in United Kingdom.
Trial summary
The goal of this clinical trial is to investigate the effects of resistance training with hydrolyzed collagen ingestion on changes in muscle and tendon adaptation in healthy young men and women. Read more about this study
- Who is it for?
- Ages 18 to 39 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Participants, Nutrition, Exercise Training
- What is being tested?
- Resistance training with hydrolyzed collagen ingestion in healthy young men and Resistance training with hydrolyzed collagen ingestion in healthy young women
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 6 Jan 2020to 31 Mar 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 39 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy young male or female
- No history of patellar tendon injuries in the past 6 months
- No history of lower limb musculoskeletal injuries in the past 6 months
- Non-smokers (including e-cigarettes)
- Free from cardiovascular and metabolic diseases
- Nullipara (a woman who has never given birth)
Who cannot join
- Age less than 18 years or higher than 40 years
- Being vegan or vegetarian (due to the mammalian source of collagen)
- Consumption of nutritional supplementation that purportedly affects muscle-tendon adaptation or recovery (i.e. protein powder, vitamin C, collagen)
- BMI over 30 kg/m2
- Previous anterior cruciate ligament injury where the patellar tendon was used as a graft
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Research Institute for Sport and Exercise Sciences
Liverpool, Merseyside, L3 3AF
About this study
Official title: The Effects of Resistance Training With Hydrolyzed Collagen Supplementation on Muscle and Tendon Adaptation in Healthy Young Adults
The goal of this clinical trial is to investigate the effects of resistance training with hydrolyzed collagen ingestion on changes in muscle and tendon adaptation in healthy young men and women.
The main questions it aims to answer are:
Read more
- Does resistance training with hydrolyzed collagen ingestion lead to greater changes in tendon properties than resistance training alone?
- Does resistance training with hydrolyzed collagen ingestion lead to greater changes in muscle size than resistance training alone?
Participants will be randomly assigned to collagen or placebo groups. Participants will perform resistance training three times per week for 10 weeks and hydrolyzed collagen or maltodextrin will be given to collagen or placebo group respectively immediately before each resistance training session. Also, vitamin C will be given to both groups.
Researchers will compare collagen and placebo groups to see if hydrolyzed collagen ingestion with resistance exercise would have beneficial effects on changes in muscle and tendon more than resistance training alone. Therefore, using isokinetic dynamometer and ultrasonography, maximal leg strength, morphological, mechanical, and material properties of the patellar tendon and vastus lateralis muscle size and architecture will be assessed.
Read the detailed description
Young, healthy, active men and women will ingest 30 grams of hydrolyzed collagen or a calorie matched beverage (maltodextrin) alongside vitamin C prior to performing high-intensity resistance training 2 - 3 times per week for 10 weeks.
The aim of this study is to investigate the effect of combining hydrolyzed collagen supplementation with resistance training in young men and women. If supplementation with hydrolyzed collagen leads to a greater change in tendon size, stiffness, and Young's modulus than resistance training alone, this will allow us to recommend this type of intervention to young athletes seeking to improve tendon health and/or athletic performance.
The experimental design and measurements will be the same in the Arm 1 and Arm 2 but the differences will be sex where participants in Arm 1 will be healthy young men while participants in Arm 2 will be healthy young women.
- Conditions
- Healthy Participants, Nutrition, Exercise Training
- Being tested
- Resistance training with hydrolyzed collagen ingestion in healthy young men, Resistance training with hydrolyzed collagen ingestion in healthy young women
- Keywords
- hydrolyzed collagen, tendon properties, maximal strength, muscle size, resistance exercise
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Resistance training with hydrolyzed collagen ingestion in healthy young menDietary supplement
Participants in this intervention will be healthy young men. The information of nutritional supplements is below.
Hydrolyzed collagen: 30 grams unflavored hydrolysed collagen (HC) (Myprotein, Cheshire, UK) 30.5 grams unflavored maltodextrin (Myprotein, Cheshire, UK) 50 milligrams vitamin C powder (Holland and Barrett Retail Limited, Warwickshire, UK) 3 grams non-caloric sweetener (Truvia®, SilverSpoon, London, UK)
Resistance training with hydrolyzed collagen ingestion in healthy young womenDietary supplement
Participants in this intervention will be healthy young women. The same nutritional supplements in Arm 1 wil be used in Arm 2.
| Study group | Role | What they receive |
|---|---|---|
| Resistance training with hydrolyzed collagen ingestion in healthy young men | Experimental | Healthy young men, pair-matched by age, body mass, height, and baseline strength, will be randomly allocated to the collagen (COL) or placebo (PLA) group.
Pre- and post-training assessments are patellar tendon properties, maximal knee flexor and extensor strengths and vastus lateralis muscle morphology using an isokinetic dynamometer and ultrasound scan.
Participants will perform the 10-week progressive resistance training program three times per week and training loads will be adjusted weekly based on the prior session's performance.
In each session, two different calorie-matched beverages were given immediately before the start of resistance training. 30 grams of hydrolyzed collagen (HC) and 30.5 grams of maltodextrin were used for COL and PLA respectively. HC or maltodextrin was mixed with 250 milliliters of water, 50 milligrams of vitamin C and 3 grams non-caloric sweetener which was used to mask flavour in an opaque bottle. Receives: Dietary Supplement: Resistance training with hydrolyzed collagen ingestion in healthy young men |
| Resistance training with hydrolyzed collagen ingestion in healthy young women | Experimental | The intervention procedure is the same as for Arm 1 except that the participants will be healthy young women (not men). Receives: Dietary Supplement: Resistance training with hydrolyzed collagen ingestion in healthy young women |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximal knee extensor (quadriceps) muscle strength
Using isokinetic dynamometer, knee extensor maximal isometric voluntary contraction torque (in Newton meters) will be measured.
Measured: 12 weeks (10 weeks' intervention plus one week either side for assessments)
Maximal knee flexor (hamstring) muscle strength
Using an isokinetic dynamometer, knee flexor maximal isometric voluntary contraction torque (in Newton meters) will be measured.
Measured: 12 weeks (10 weeks' intervention plus one week either side for pre- and post-intervention assessments)
Patellar tendon cross-sectional area
Using ultrasonography, patellar tendon cross-sectional area (in millimeters squared) will be measured.
Measured: 12 weeks (10 weeks' intervention plus one week either side for pre- and post-intervention assessments)
Patellar tendon stiffness
Using ultrasonography, patellar tendon stiffness (in Newtons per millimeter) will be measured.
Measured: 12 weeks (10 weeks' intervention plus one week either side for pre- and post-intervention assessments)
Vastus lateralis (VL) muscle size
Using ultrasonography, the VL anatomical cross-sectional area (in centimeters squared) will be measured.
Measured: 12 weeks (10 weeks' intervention plus one week either side for pre- and post-intervention assessments)
Vastus lateralis (VL) muscle fascicle length
Using ultrasonography, VL muscle fascicle length (in millimeters) will be measured.
Measured: 12 weeks (10 weeks' intervention plus one week either side for pre- and post-intervention assessments)
Vastus lateralis (VL) muscle fascicle pennation angle
Using ultrasonography, VL muscle fascicle pennation angle (in degrees) will be measured.
Measured: 12 weeks (10 weeks' intervention plus one week either side for pre- and post-intervention assessments)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2024
- Study start6 Jan 2020
- Primary completion29 Sep 2021
- Study completion31 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy ParticipantsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The study design is a single-blind (participants were unaware of their group allocation), randomized controlled trial.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Liverpool John Moores University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06372080
- Sponsor's protocol ID
- 19/SPS/054
- Status last verified
- Feb 2024
- First submitted
- 3 Apr 2024
- Last updated
- 17 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Resistance Training With Hydrolyzed Collagen Supplementation on Muscle and Tendon Adaptation in Healthy Young Adults
- ClinicalTrials.gov ID
- NCT06372080
- Acronym / sponsor ID
- 19/SPS/054
- Conditions
- Healthy Participants, Nutrition, Exercise Training
- Keywords
- hydrolyzed collagen, tendon properties, maximal strength, muscle size, resistance exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Liverpool John Moores UniversityUniversity, hospital or other
- Study start
- 6 Jan 2020 (actual)
- Primary completion
- 29 Sep 2021 (actual)
- Study completion
- 31 Mar 2023 (actual)
- First posted
- 17 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical trial is to investigate the effects of resistance training with hydrolyzed collagen ingestion on changes in muscle and tendon adaptation in healthy young men and women.
The main questions it aims to answer are:
- Does resistance training with hydrolyzed collagen ingestion lead to greater changes in tendon properties than resistance training alone?
- Does resistance training with hydrolyzed collagen ingestion lead to greater changes in muscle size than resistance training alone?
Participants will be randomly assigned to collagen or placebo groups. Participants will perform resistance training three times per week for 10 weeks and hydrolyzed collagen or maltodextrin will be given to collagen or placebo group respectively immediately before each resistance training session. Also, vitamin C will be given to both groups.
Researchers will compare collagen and placebo groups to see if hydrolyzed collagen ingestion with resistance exercise would have beneficial effects on changes in muscle and tendon more than resistance training alone. Therefore, using isokinetic dynamometer and ultrasonography, maximal leg strength, morphological, mechanical, and material properties of the patellar tendon and vastus lateralis muscle size and architecture will be assessed.
Detailed description
Young, healthy, active men and women will ingest 30 grams of hydrolyzed collagen or a calorie matched beverage (maltodextrin) alongside vitamin C prior to performing high-intensity resistance training 2 - 3 times per week for 10 weeks.
The aim of this study is to investigate the effect of combining hydrolyzed collagen supplementation with resistance training in young men and women. If supplementation with hydrolyzed collagen leads to a greater change in tendon size, stiffness, and Young's modulus than resistance training alone, this will allow us to recommend this type of intervention to young athletes seeking to improve tendon health and/or athletic performance.
The experimental design and measurements will be the same in the Arm 1 and Arm 2 but the differences will be sex where participants in Arm 1 will be healthy young men while participants in Arm 2 will be healthy young women.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- The study design is a single-blind (participants were unaware of their group allocation), randomized controlled trial.
| Arm | Type | Receives |
|---|---|---|
| Resistance training with hydrolyzed collagen ingestion in healthy young men | Experimental | Dietary Supplement: Resistance training with hydrolyzed collagen ingestion in healthy young menHealthy young men, pair-matched by age, body mass, height, and baseline strength, will be randomly allocated to the collagen (COL) or placebo (PLA) group. Pre- and post-training assessments are patellar tendon properties, maximal knee flexor and extensor strengths and vastus lateralis muscle morphology using an isokinetic dynamometer and ultrasound scan. Participants will perform the 10-week progressive resistance training program three times per week and training loads will be adjusted weekly based on the prior session's performance. In each session, two different calorie-matched beverages were given immediately before the start of resistance training. 30 grams of hydrolyzed collagen (HC) and 30.5 grams of maltodextrin were used for COL and PLA respectively. HC or maltodextrin was mixed with 250 milliliters of water, 50 milligrams of vitamin C and 3 grams non-caloric sweetener which was used to mask flavour in an opaque bottle. |
| Resistance training with hydrolyzed collagen ingestion in healthy young women | Experimental | Dietary Supplement: Resistance training with hydrolyzed collagen ingestion in healthy young womenThe intervention procedure is the same as for Arm 1 except that the participants will be healthy young women (not men). |
Who may qualify
- Ages
- 18 to 39 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Healthy young male or female
- No history of patellar tendon injuries in the past 6 months
- No history of lower limb musculoskeletal injuries in the past 6 months
- Non-smokers (including e-cigarettes)
- Free from cardiovascular and metabolic diseases
Key exclusion criteria (5 listed)
- Age less than 18 years or higher than 40 years
- Being vegan or vegetarian (due to the mammalian source of collagen)
- Consumption of nutritional supplementation that purportedly affects muscle-tendon adaptation or recovery (i.e. protein powder, vitamin C, collagen)
- BMI over 30 kg/m2
- Previous anterior cruciate ligament injury where the patellar tendon was used as a graft
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Resistance training with hydrolyzed collagen ingestion in healthy young menParticipants in this intervention will be healthy young men. The information of nutritional supplements is below. Hydrolyzed collagen: 30 grams unflavored hydrolysed collagen (HC) (Myprotein, Cheshire, UK) 30.5 grams unflavored maltodextrin (Myprotein, Cheshire, UK) 50 milligrams vitamin C powder (Holland and Barrett Retail Limited, Warwickshire, UK) 3 grams non-caloric sweetener (Truvia®, SilverSpoon, London, UK) | Dietary supplement | Resistance training with hydrolyzed collagen ingestion in healthy young men |
| Resistance training with hydrolyzed collagen ingestion in healthy young womenParticipants in this intervention will be healthy young women. The same nutritional supplements in Arm 1 wil be used in Arm 2. | Dietary supplement | Resistance training with hydrolyzed collagen ingestion in healthy young women |
Primary outcome
Maximal knee extensor (quadriceps) muscle strength
Time frame: 12 weeks (10 weeks' intervention plus one week either side for assessments)
Using isokinetic dynamometer, knee extensor maximal isometric voluntary contraction torque (in Newton meters) will be measured.
Maximal knee flexor (hamstring) muscle strength
Time frame: 12 weeks (10 weeks' intervention plus one week either side for pre- and post-intervention assessments)
Using an isokinetic dynamometer, knee flexor maximal isometric voluntary contraction torque (in Newton meters) will be measured.
Patellar tendon cross-sectional area
Time frame: 12 weeks (10 weeks' intervention plus one week either side for pre- and post-intervention assessments)
Using ultrasonography, patellar tendon cross-sectional area (in millimeters squared) will be measured.
Patellar tendon stiffness
Time frame: 12 weeks (10 weeks' intervention plus one week either side for pre- and post-intervention assessments)
Using ultrasonography, patellar tendon stiffness (in Newtons per millimeter) will be measured.
Vastus lateralis (VL) muscle size
Time frame: 12 weeks (10 weeks' intervention plus one week either side for pre- and post-intervention assessments)
Using ultrasonography, the VL anatomical cross-sectional area (in centimeters squared) will be measured.
Vastus lateralis (VL) muscle fascicle length
Time frame: 12 weeks (10 weeks' intervention plus one week either side for pre- and post-intervention assessments)
Using ultrasonography, VL muscle fascicle length (in millimeters) will be measured.
Vastus lateralis (VL) muscle fascicle pennation angle
Time frame: 12 weeks (10 weeks' intervention plus one week either side for pre- and post-intervention assessments)
Using ultrasonography, VL muscle fascicle pennation angle (in degrees) will be measured.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Resistance training with hydrolyzed collagen ingestion in healthy young men and Resistance training with hydrolyzed collagen ingestion in healthy young women in people with Healthy Participants and Nutrition, run by Liverpool John Moores University at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximal knee extensor (quadriceps) muscle strength (time frame: 12 weeks (10 weeks' intervention plus one week either side for assessments)). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Apr 2024.