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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:
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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Resistance training with collagen supplementation | Dietary 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:
Day 2:
Linear progression adjusted weekly loads. If participants completed the prescribed sets and reps, loads increased by 2.5-5 % the following week. |
| Measure | Description | Time Frame |
|---|---|---|
| m. vastus lateralis thickness (in millimetres) | Ultrasonography was used to determine changes in muscle thicknessprotocols | 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 | 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 | 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 | 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). | 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) | 8-12 weeks' training and nutrition intervention |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Robert M Erskine, PhD | Liverpool John Moores University | Study Director |
| Christopher D Nulty, MSc | Liverpool John Moores University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dr Rob Erskine | Liverpool | L3 3AF | United Kingdom |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP_ICF | Yes | Yes | Yes | Study Protocol, Statistical Analysis Plan, and Informed Consent Form | Apr 22, 2024 | Apr 23, 2024 | Prot_SAP_ICF_000.pdf |
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| ID | Term |
|---|---|
| D055070 | Resistance Training |
| ID | Term |
|---|---|
| D005081 | Exercise Therapy |
| D012046 | Rehabilitation |
| D000359 | Aftercare |
| D003266 | Continuity of Patient Care |
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Double-blind, placebo-controlled trial
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Before the intervention commenced, a laboratory technician (independent to the study) made up the dry ingestions all the 30 g doses of hydrolyzed collagen (HC), and calorie matched placebo and stored in sachets. These sachets were labelled as with the participants name. The technician randomly assigned either HC or placebo to participants who were pair matched (Excel 2016, Microsoft, Washington, USA). The groupings and contents of the sachets were unknown to the researcher and the participants, who all remained blinded until data collection and analysis were complete.
|
| 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) | 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 | 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 | 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 | 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 | 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 | 8-12 weeks' training and nutrition intervention |
| D005791 |
| Patient Care |
| D013812 | Therapeutics |
| D026741 | Physical Therapy Modalities |
| D064797 | Physical Conditioning, Human |
| D015444 | Exercise |
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |