Clinical Trials Logo

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)
See also
  Status Clinical Trial Phase
Completed NCT05445440 - A Study to Assess the Effects of BMS-986371 on the Drug Levels of Methotrexate in the Presence and Absence of Sulfasalazine Phase 1
Completed NCT03712540 - An Investigational Study of Experimental Medication BMS-986278 Given With the Antibiotic Rifampin in Healthy Participants Phase 1
Completed NCT03649165 - A Study to Evaluate Bioavailability and Food Effect of Selumetinib (AZD6244) in Healthy Male Participants Phase 1
Completed NCT05956002 - A Study to Evaluate the Study Medication (Etrasimod) When Mixed With Food in Healthy Participants Phase 1
Completed NCT05539976 - A Taste Assessment of Iberdomide and Mezigdomide in Healthy Participants
Withdrawn NCT04558216 - Evaluation of Effect of Rifampin on the Pharmacokinetics of Vonoprazan in Healthy Participants Phase 1
Withdrawn NCT03007771 - Magnetic Resonance-guided High-Intensity Focused Ultrasound (MR-HIFU) Used for Mild Hyperthermia Phase 1
Completed NCT06097390 - A Research Study Looking at New Protein-based Tablets in Healthy Men - Oral Formulation III Phase 1
Completed NCT05546151 - A Study to Assess the Safety and Tolerability of BMS-986322 in Healthy Participants of Japanese Descent Phase 1
Completed NCT05056246 - Study of AMG 133 Administered Subcutaneously in Healthy Japanese and Caucasian Participants Phase 1
Completed NCT04390776 - Bioequivalence Study of PF-06651600 Capsules Relative to Tablets and Estimation of Food Effect on Capsules. Phase 1
Completed NCT05074459 - A Study in Healthy Adults Investigating Eptinezumab Produced by 2 Different Manufacturing Cell Lines Phase 1
Enrolling by invitation NCT06089109 - Creating VIP Corps to Reduce Maternal Deaths N/A
Completed NCT05996250 - Tolerance of an Immersive Virtual Reality Task Evaluating the Spatial Memory of Elderly Subjects N/A
Completed NCT03278080 - Development of Assessment Method for Driving Ability Using Driving Simulator in Healthy Volunteers #1 N/A
Completed NCT05064800 - PF-07321332/Ritonavir and Ritonavir on Dabigatran Study in Healthy Participants Phase 1
Completed NCT04471298 - A Study of Qishenyiqi Dripping Pills in Healthy Participants Phase 1
Completed NCT04914936 - A Study to Evaluate the One-way Interaction of Calcium Carbonate, Omeprazole, or Rifampin on ACP-196 Phase 1
Completed NCT01681186 - A Study of LY2940680 in Healthy Participants Phase 1
Completed NCT02882386 - Amino Acid Kinetics in Blood After Consuming Different Milk Protein Supplements N/A