NCT06372080

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
23

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2020

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 6, 2020

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 29, 2021

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2023

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

April 3, 2024

Completed
14 days until next milestone

First Posted

Study publicly available on registry

April 17, 2024

Completed
Last Updated

April 17, 2024

Status Verified

February 1, 2024

Enrollment Period

1.7 years

First QC Date

April 3, 2024

Last Update Submit

April 12, 2024

Conditions

Keywords

hydrolyzed collagentendon propertiesmaximal strengthmuscle sizeresistance exercise

Outcome Measures

Primary Outcomes (7)

  • 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)

  • 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)

  • 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)

  • 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)

  • 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)

  • 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)

  • 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)

Study Arms (2)

Resistance training with hydrolyzed collagen ingestion in healthy young men

EXPERIMENTAL

Healthy young men, pair-matched by age, body mass, height, and baseline strength, will be randomly allocated to the collagen (COL) or placebo (PLA) group. Pre- and post-training assessments are patellar tendon properties, maximal knee flexor and extensor strengths and vastus lateralis muscle morphology using an isokinetic dynamometer and ultrasound scan. Participants will perform the 10-week progressive resistance training program three times per week and training loads will be adjusted weekly based on the prior session's performance. In each session, two different calorie-matched beverages were given immediately before the start of resistance training. 30 grams of hydrolyzed collagen (HC) and 30.5 grams of maltodextrin were used for COL and PLA respectively. HC or maltodextrin was mixed with 250 milliliters of water, 50 milligrams of vitamin C and 3 grams non-caloric sweetener which was used to mask flavour in an opaque bottle.

Dietary Supplement: Resistance training with hydrolyzed collagen ingestion in healthy young men

Resistance training with hydrolyzed collagen ingestion in healthy young women

EXPERIMENTAL

The intervention procedure is the same as for Arm 1 except that the participants will be healthy young women (not men).

Dietary Supplement: Resistance training with hydrolyzed collagen ingestion in healthy young women

Interventions

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 men

Participants in this intervention will be healthy young women. The same nutritional supplements in Arm 1 wil be used in Arm 2.

Resistance training with hydrolyzed collagen ingestion in healthy young women

Eligibility Criteria

Age18 Years - 39 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Research Institute for Sport and Exercise Sciences

Liverpool, Merseyside, L3 3AF, United Kingdom

Location

MeSH Terms

Interventions

Resistance Training

Intervention Hierarchy (Ancestors)

Exercise TherapyRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy ModalitiesPhysical Conditioning, HumanExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Model Details: The study design is a single-blind (participants were unaware of their group allocation), randomized controlled trial.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 3, 2024

First Posted

April 17, 2024

Study Start

January 6, 2020

Primary Completion

September 29, 2021

Study Completion

March 31, 2023

Last Updated

April 17, 2024

Record last verified: 2024-02

Data Sharing

IPD Sharing
Will not share

Locations