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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06372080
Other study ID # 19/SPS/054
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 6, 2020
Est. completion date March 31, 2023

Study information

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

Clinical 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. 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 23
Est. completion date March 31, 2023
Est. primary completion date September 29, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 39 Years
Eligibility Inclusion Criteria: - 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) Exclusion Criteria: - 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

Study Design


Related Conditions & MeSH terms


Intervention

Dietary Supplement:
Resistance training with hydrolyzed collagen ingestion in healthy young men
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 women
Participants in this intervention will be healthy young women. The same nutritional supplements in Arm 1 wil be used in Arm 2.

Locations

Country Name City State
United Kingdom Research Institute for Sport and Exercise Sciences Liverpool Merseyside

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 Maximal knee extensor (quadriceps) muscle strength Using isokinetic dynamometer, knee extensor maximal isometric voluntary contraction torque (in Newton meters) will be measured. 12 weeks (10 weeks' intervention plus one week either side for assessments)
Primary Maximal knee flexor (hamstring) muscle strength Using an isokinetic dynamometer, knee flexor maximal isometric voluntary contraction torque (in Newton meters) will be measured. 12 weeks (10 weeks' intervention plus one week either side for pre- and post-intervention assessments)
Primary Patellar tendon cross-sectional area Using ultrasonography, patellar tendon cross-sectional area (in millimeters squared) will be measured. 12 weeks (10 weeks' intervention plus one week either side for pre- and post-intervention assessments)
Primary Patellar tendon stiffness Using ultrasonography, patellar tendon stiffness (in Newtons per millimeter) will be measured. 12 weeks (10 weeks' intervention plus one week either side for pre- and post-intervention assessments)
Primary Vastus lateralis (VL) muscle size Using ultrasonography, the VL anatomical cross-sectional area (in centimeters squared) will be measured. 12 weeks (10 weeks' intervention plus one week either side for pre- and post-intervention assessments)
Primary Vastus lateralis (VL) muscle fascicle length Using ultrasonography, VL muscle fascicle length (in millimeters) will be measured. 12 weeks (10 weeks' intervention plus one week either side for pre- and post-intervention assessments)
Primary Vastus lateralis (VL) muscle fascicle pennation angle Using ultrasonography, VL muscle fascicle pennation angle (in degrees) will be measured. 12 weeks (10 weeks' intervention plus one week either side for pre- and post-intervention assessments)
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