DietNCT06402890
Resistance Training and Hydrolyzed Collagen Supplementation in Middle-aged Adults
A study testing Resistance training with collagen supplementation in people with Diet and Food, run by Liverpool John Moores University at 1 site in United Kingdom.
Trial summary
The aim of this clinical trial is to investigate the longitudinal effects of hydrolyzed collagen ingestion combined with resistance training on muscle-tendon unit structure and function in middle-aged males and females. The main research questions this clinical trial aims to answer are: 1. Read more about this study
- Who is it for?
- Ages 35 to 59 yearsHealthy volunteers can take part
- What is being tested?
- Resistance training with collagen supplementation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Jul 2021to 13 Jul 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 35 to 59 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Recreationally active or competing in Masters sport
- 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
Who cannot join
- Age < 35 years or > 59 years
- Being vegan or vegetarian (due to the mammalian source of collagen)
- Injury history incompatible with lower body resistance training
- Consumption of nutritional supplementation that purportedly affects muscle-tendon adaptation or recovery (i.e. protein powder, vitamin C, collagen)
- BMI over 30 kg/m2
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Vitamin C-enriched Collagen Combined With Resistance Training on Muscle-tendon Unit Properties in Middle-aged Men and Women
The aim of this clinical trial is to investigate the longitudinal effects of hydrolyzed collagen ingestion combined with resistance training on muscle-tendon unit structure and function in middle-aged males and females.
The main research questions this clinical trial aims to answer are:
Read more
- Does resistance training with hydrolyzed collagen ingestion lead to greater changes in tendon properties than resistance training alone in middle-aged health men and women?
- Does resistance training with hydrolyzed collagen ingestion lead to greater changes in muscle size than resistance training alone?
- Does resistance training with hydrolyzed collagen lead to greater increases in strength and power compared to resistance training alone in middle-aged, healthy men and women?
Participants will be randomly assigned to collagen or placebo groups. Participants will perform 24 sessions of high intensity resistance training across 12-weeks. Alongside each training session, participants will consume a beverage containing hydrolyzed collagen or maltodextrin, with both beverages containing vitamin C.
Researchers will compare the collagen and placebo groups to see if there would be beneficial effects on changes in muscle and tendon that are greater than resistance training alone. To achieve this, an dynamometry will be used to assess lower limb strength and ultrasound will be used to measure the morphological, mechanical, and material properties of the patellar tendon, as well the size and architecture of the vastus lateralis muscle.
Read the detailed description
Healthy, active, middle-aged men and women will ingest a beverage containing 30 g of hydrolyzed collagen with 50 mg of vitamin C or a calorie matched beverage (maltodextrin), also with 50 mg of vitamin C combined with high-volume, high-intensity resistance training for the lower body on 2 - 3 occasions per week for 8-12 weeks.
The aim of this study was to investigate the effect of combining hydrolyzed collagen with resistance training in middle-aged 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. This is the first study to investigate the combination of hydrolyzed collage supplementation with resistance training in middle-aged men and women. If supplementation with hydrolyzed leads to greater improvements in tendon size, stiffness, strength and/or power, this will allow us to recommend this type of intervention to middle-aged athletes/trainees seeking to improve tendon health, reduce injury risk, or enhance athletic performance.
The experimental design of both arms will be the same, however Arm 1 will be health, middle-aged male participants and Arm 2 will be health, middle-aged female participants.
- Being tested
- Resistance training with collagen supplementation
- Keywords
- Hydrolyzed collagen, Middle-age, Resistance training, Tendon properties
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Resistance training with collagen supplementationDietary supplement
Participants performed 24 lower limb resistance training sessions over under supervision from the principal investigator. Participants were pair-matched, then allocated to hydrolysed collagen (COL) or a calorie-matched beverage comprising maltodextrin and non-caloric sweetener (PLA). Both COL and PLA consumed their respective supplements in conjunction with each resistance training session.
Baseline assessments of strength were used to set initial training loads. An example of weekly training is included below for indicative purposes:
Week 1 protocol:
Day 1:
- Barbell squat, 4 sets @ 90% 10-RM
- Romanian deadlift, 4 sets @ 90% 10-RM
Day 2:
- Hex bar deadlift, 4 sets @ 90% 10-RM
- Dumbbell goblet squat, 4 sets @ 90% 10-RM
Linear progression adjusted weekly loads. If participants completed the prescribed sets and reps, loads increased by 2.5-5 % the following week.
| Study group | Role | What they receive |
|---|---|---|
| Resistance training with hydrolyzed collagen in health, active, middle-aged men | Experimental | Middle-aged, trained males completed 12-weeks of a supervised, progressive resistance training programme while consuming 30 g of hydrolyzed collagen or a calorie matched placebo beverage. Receives: Dietary Supplement: Resistance training with collagen supplementation |
| Resistance training with hydrolyzed collagen in healthy, active, middle-aged women | Experimental | Middle-aged, trained females completed 8-weeks of a supervised, progressive resistance training programme while consuming 30 g of hydrolyzed collagen or a calorie matched placebo beverage Receives: Dietary Supplement: Resistance training with collagen supplementation |
What is being measured
The primary outcome is the main question the study is designed to answer.
m. vastus lateralis thickness (in millimetres)
Ultrasonography was used to determine changes in muscle thicknessprotocols
Measured: 8-12 weeks' training and nutrition intervention
m. vastus lateralis fascicle pennation angle (in degrees)
Ultrasonography was used to determine the pennation angle of fascicles as they insert into the aponeurosis
Measured: 8-12 weeks' training and nutrition intervention
Patellar tendon cross sectional area (in squared millimetres) at 3 regions along the tendon length
Ultrasonography was used to determine changes in tendon cross sectional area at 25, 50, and 75 % of tendon length
Measured: 8-12 weeks' training and nutrition intervention
Patellar tendon stiffness (in Newtons per millimetre)
Synchronized ultrasonography, dynamometry, and surface electromyography were used to determine changes in patellar tendon stiffness
Measured: 8-12 weeks' training and nutrition intervention
Bilateral vertical countermovement jump height (in centimetres)
Changes in jump height were estimated by use of the Optojump system (Microgate, Bolzano, Italy) and force plates (Force Decks Dual Force Plate System, VALD, Charlotte NC, USA).
Measured: 8-12 weeks' training and nutrition intervention
Knee extensor maximal isometric torque (in Newton metres)
Changes in maximal knee extension strength were measured using isometric dynamometry (Biodex System 3, IPRS Mediquipe Limited, Lancashire, UK)
Measured: 8-12 weeks' training and nutrition intervention
Knee extensor rate of torque development (in Newton metres per second)
Changes in explosive knee extension strength were measured using isometric dynamometry (Biodex System 3, IPRS Mediquipe Limited, Lancashire, UK)
Measured: 8-12 weeks' training and nutrition intervention
Barbell back squat 10-repetition maximum (in kilograms)
Changes in dynamic lower body strength were measured using the maximum load during 10 repetitions of the barbell back squat exercise with standardised technique
Measured: 8-12 weeks' training and nutrition intervention
Bilateral horizontal broad jump distance (in centimetres)
Changes in maximal horizontal displacement were measured as the maximum distance covered during a broad jump on standardised surface without footwear
Measured: 8-12 weeks' training and nutrition intervention
Lower limb maximal isometric force (in Newtons)
Force plates (Force Decks Dual Force Plate System, VALD, Charlotte NC, USA) were used to measure changes in maximal multi-joint isometric strength during the mid-thigh pull exercise
Measured: 8-12 weeks' training and nutrition intervention
Lower limb isometric rate of force development (in Newtons per second)
Force plates (Force Decks Dual Force Plate System, VALD, Charlotte NC, USA) were used to measure changes in explosive multi-joint isometric strength during the mid-thigh pull exercise
Measured: 8-12 weeks' training and nutrition intervention
20-metre sprint time (in seconds)
Double photocell timing gates (Witty System, Microgate SRL, Bolzano, Italy) were used to measure changes in time taken to cover 20-metres during an all out sprint on a standardised surface
Measured: 8-12 weeks' training and nutrition intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2024
- Study start1 Jul 2021
- Primary completion13 Jul 2023
- Study completion13 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DietStudies 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
- Double-blind, placebo-controlled trial
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Liverpool John Moores University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Robert M Erskine, PhD, Study director, Liverpool John Moores UniversityChristopher D Nulty, MSc, Principal investigator, Liverpool John Moores University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06402890
- Sponsor's protocol ID
- 300
- Status last verified
- May 2024
- First submitted
- 17 Apr 2024
- Last updated
- 7 May 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 7 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Vitamin C-enriched Collagen Combined With Resistance Training on Muscle-tendon Unit Properties in Middle-aged Men and Women
- ClinicalTrials.gov ID
- NCT06402890
- Acronym / sponsor ID
- 300
- Keywords
- Hydrolyzed collagen, Middle-age, Resistance training, Tendon properties
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Liverpool John Moores UniversityUniversity, hospital or other
- Study start
- 1 Jul 2021 (actual)
- Primary completion
- 13 Jul 2023 (actual)
- Study completion
- 13 Jul 2023 (actual)
- First posted
- 7 May 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 aim of this clinical trial is to investigate the longitudinal effects of hydrolyzed collagen ingestion combined with resistance training on muscle-tendon unit structure and function in middle-aged males and females.
The main research questions this clinical trial aims to answer are:
- Does resistance training with hydrolyzed collagen ingestion lead to greater changes in tendon properties than resistance training alone in middle-aged health men and women?
- Does resistance training with hydrolyzed collagen ingestion lead to greater changes in muscle size than resistance training alone?
- Does resistance training with hydrolyzed collagen lead to greater increases in strength and power compared to resistance training alone in middle-aged, healthy men and women?
Participants will be randomly assigned to collagen or placebo groups. Participants will perform 24 sessions of high intensity resistance training across 12-weeks. Alongside each training session, participants will consume a beverage containing hydrolyzed collagen or maltodextrin, with both beverages containing vitamin C.
Researchers will compare the collagen and placebo groups to see if there would be beneficial effects on changes in muscle and tendon that are greater than resistance training alone. To achieve this, an dynamometry will be used to assess lower limb strength and ultrasound will be used to measure the morphological, mechanical, and material properties of the patellar tendon, as well the size and architecture of the vastus lateralis muscle.
Detailed description
Healthy, active, middle-aged men and women will ingest a beverage containing 30 g of hydrolyzed collagen with 50 mg of vitamin C or a calorie matched beverage (maltodextrin), also with 50 mg of vitamin C combined with high-volume, high-intensity resistance training for the lower body on 2 - 3 occasions per week for 8-12 weeks.
The aim of this study was to investigate the effect of combining hydrolyzed collagen with resistance training in middle-aged 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. This is the first study to investigate the combination of hydrolyzed collage supplementation with resistance training in middle-aged men and women. If supplementation with hydrolyzed leads to greater improvements in tendon size, stiffness, strength and/or power, this will allow us to recommend this type of intervention to middle-aged athletes/trainees seeking to improve tendon health, reduce injury risk, or enhance athletic performance.
The experimental design of both arms will be the same, however Arm 1 will be health, middle-aged male participants and Arm 2 will be health, middle-aged female participants.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Double-blind, placebo-controlled trial
| Arm | Type | Receives |
|---|---|---|
| Resistance training with hydrolyzed collagen in health, active, middle-aged men | Experimental | Dietary Supplement: Resistance training with collagen supplementationMiddle-aged, trained males completed 12-weeks of a supervised, progressive resistance training programme while consuming 30 g of hydrolyzed collagen or a calorie matched placebo beverage. |
| Resistance training with hydrolyzed collagen in healthy, active, middle-aged women | Experimental | Dietary Supplement: Resistance training with collagen supplementationMiddle-aged, trained females completed 8-weeks of a supervised, progressive resistance training programme while consuming 30 g of hydrolyzed collagen or a calorie matched placebo beverage |
Who may qualify
- Ages
- 35 to 59 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Recreationally active or competing in Masters sport
- 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 < 35 years or > 59 years
- Being vegan or vegetarian (due to the mammalian source of collagen)
- Injury history incompatible with lower body resistance training
- Consumption of nutritional supplementation that purportedly affects muscle-tendon adaptation or recovery (i.e. protein powder, vitamin C, collagen)
- BMI over 30 kg/m2
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 collagen supplementationParticipants performed 24 lower limb resistance training sessions over under supervision from the principal investigator. Participants were pair-matched, then allocated to hydrolysed collagen (COL) or a calorie-matched beverage comprising maltodextrin and non-caloric sweetener (PLA). Both COL and PLA consumed their respective supplements in conjunction with each resistance training session. Baseline assessments of strength were used to set initial training loads. An example of weekly training is included below for indicative purposes: Week 1 protocol: Day 1: * Barbell squat, 4 sets @ 90% 10-RM * Romanian deadlift, 4 sets @ 90% 10-RM Day 2: * Hex bar deadlift, 4 sets @ 90% 10-RM * Dumbbell goblet squat, 4 sets @ 90% 10-RM Linear progression adjusted weekly loads. If participants completed the prescribed sets and reps, loads increased by 2.5-5 % the following week. | Dietary supplement | Resistance training with hydrolyzed collagen in health, active, middle-aged men, Resistance training with hydrolyzed collagen in healthy, active, middle-aged women |
Primary outcome
m. vastus lateralis thickness (in millimetres)
Time frame: 8-12 weeks' training and nutrition intervention
Ultrasonography was used to determine changes in muscle thicknessprotocols
m. vastus lateralis fascicle pennation angle (in degrees)
Time frame: 8-12 weeks' training and nutrition intervention
Ultrasonography was used to determine the pennation angle of fascicles as they insert into the aponeurosis
Patellar tendon cross sectional area (in squared millimetres) at 3 regions along the tendon length
Time frame: 8-12 weeks' training and nutrition intervention
Ultrasonography was used to determine changes in tendon cross sectional area at 25, 50, and 75 % of tendon length
Patellar tendon stiffness (in Newtons per millimetre)
Time frame: 8-12 weeks' training and nutrition intervention
Synchronized ultrasonography, dynamometry, and surface electromyography were used to determine changes in patellar tendon stiffness
Bilateral vertical countermovement jump height (in centimetres)
Time frame: 8-12 weeks' training and nutrition intervention
Changes in jump height were estimated by use of the Optojump system (Microgate, Bolzano, Italy) and force plates (Force Decks Dual Force Plate System, VALD, Charlotte NC, USA).
Knee extensor maximal isometric torque (in Newton metres)
Time frame: 8-12 weeks' training and nutrition intervention
Changes in maximal knee extension strength were measured using isometric dynamometry (Biodex System 3, IPRS Mediquipe Limited, Lancashire, UK)
Knee extensor rate of torque development (in Newton metres per second)
Time frame: 8-12 weeks' training and nutrition intervention
Changes in explosive knee extension strength were measured using isometric dynamometry (Biodex System 3, IPRS Mediquipe Limited, Lancashire, UK)
Barbell back squat 10-repetition maximum (in kilograms)
Time frame: 8-12 weeks' training and nutrition intervention
Changes in dynamic lower body strength were measured using the maximum load during 10 repetitions of the barbell back squat exercise with standardised technique
Bilateral horizontal broad jump distance (in centimetres)
Time frame: 8-12 weeks' training and nutrition intervention
Changes in maximal horizontal displacement were measured as the maximum distance covered during a broad jump on standardised surface without footwear
Lower limb maximal isometric force (in Newtons)
Time frame: 8-12 weeks' training and nutrition intervention
Force plates (Force Decks Dual Force Plate System, VALD, Charlotte NC, USA) were used to measure changes in maximal multi-joint isometric strength during the mid-thigh pull exercise
Lower limb isometric rate of force development (in Newtons per second)
Time frame: 8-12 weeks' training and nutrition intervention
Force plates (Force Decks Dual Force Plate System, VALD, Charlotte NC, USA) were used to measure changes in explosive multi-joint isometric strength during the mid-thigh pull exercise
20-metre sprint time (in seconds)
Time frame: 8-12 weeks' training and nutrition intervention
Double photocell timing gates (Witty System, Microgate SRL, Bolzano, Italy) were used to measure changes in time taken to cover 20-metres during an all out sprint on a standardised surface
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 7 May 2024.
- Individual participant dataSharing planned: No
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Healthy Volunteers
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.
Robert M Erskine, PhD study director
Liverpool John Moores University
Christopher D Nulty, MSc principal investigator
Liverpool John Moores University
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 collagen supplementation in people with Diet and Food, 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 5 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 7 May 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?
m. vastus lateralis thickness (in millimetres) (time frame: 8-12 weeks' training and nutrition intervention). The study lists 12 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 7 May 2024.