- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06402890
Resistance Training and Hydrolyzed Collagen Supplementation in Middle-aged Adults
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:
- 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.
Study Overview
Status
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Liverpool, United Kingdom, L3 3AF
- Dr Rob Erskine
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Resistance training with hydrolyzed collagen in health, active, middle-aged men
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.
|
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:
Day 2:
Linear progression adjusted weekly loads. If participants completed the prescribed sets and reps, loads increased by 2.5-5 % the following week. |
|
Experimental: Resistance training with hydrolyzed collagen in healthy, active, middle-aged women
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
|
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:
Day 2:
Linear progression adjusted weekly loads. If participants completed the prescribed sets and reps, loads increased by 2.5-5 % the following week. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
m. vastus lateralis thickness (in millimetres)
Time Frame: 8-12 weeks' training and nutrition intervention
|
Ultrasonography was used to determine changes in muscle thicknessprotocols
|
8-12 weeks' training and nutrition intervention
|
|
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
|
8-12 weeks' training and nutrition intervention
|
|
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
|
8-12 weeks' training and nutrition intervention
|
|
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
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8-12 weeks' training and nutrition intervention
|
|
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).
|
8-12 weeks' training and nutrition intervention
|
|
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)
|
8-12 weeks' training and nutrition intervention
|
|
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)
|
8-12 weeks' training and nutrition intervention
|
|
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
|
8-12 weeks' training and nutrition intervention
|
|
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
|
8-12 weeks' training and nutrition intervention
|
|
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
|
8-12 weeks' training and nutrition intervention
|
|
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
|
8-12 weeks' training and nutrition intervention
|
|
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
|
8-12 weeks' training and nutrition intervention
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Robert M Erskine, PhD, Liverpool John Moores University
- Principal Investigator: Christopher D Nulty, MSc, Liverpool John Moores University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 300
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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