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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06402890
Other study ID # 300
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date July 1, 2021
Est. completion date July 13, 2023

Study information

Verified date May 2024
Source Liverpool John Moores University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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? 2. Does resistance training with hydrolyzed collagen ingestion lead to greater changes in muscle size than resistance training alone? 3. 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 42
Est. completion date July 13, 2023
Est. primary completion date July 13, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 35 Years to 59 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Dietary Supplement:
Resistance training with collagen supplementation
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.

Locations

Country Name City State
United Kingdom Dr Rob Erskine Liverpool

Sponsors (1)

Lead Sponsor Collaborator
Liverpool John Moores University

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary m. vastus lateralis thickness (in millimetres) Ultrasonography was used to determine changes in muscle thicknessprotocols 8-12 weeks' training and nutrition intervention
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
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