Resistance Training and Hydrolyzed Collagen Supplementation in Healthy Young Adults

• ClinicalTrials.gov Identifier: NCT06372080
• Recruitment Status: Completed
• First Posted: April 17, 2024
• Last Update Posted: April 17, 2024
• Sponsor: Liverpool John Moores University
• Information provided by (Responsible Party): Liverpool John Moores University

Tracking Information

• First Submitted Date: April 3, 2024
• First Posted Date: April 17, 2024
• Last Update Posted Date: April 17, 2024
• Actual Study Start Date: January 6, 2020
• Actual Primary Completion Date: September 29, 2021 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: April 12, 2024)

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

• Original Primary Outcome Measures: Same as current
• Change History: No Changes Posted
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Resistance Training and Hydrolyzed Collagen Supplementation in Healthy Young Adults
• Official Title: The Effects of Resistance Training With Hydrolyzed Collagen Supplementation on Muscle and Tendon Adaptation in Healthy Young Adults

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.

Detailed 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.

• Study Type: Interventional
• Study Phase: Not Applicable

Study Design

Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

The study design is a single-blind (participants were unaware of their group allocation), randomized controlled trial.

Masking: Single (Participant)
Primary Purpose: Basic Science

Condition

• Healthy Participants
• Nutrition
• Exercise Training

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)

• Dietary Supplement: 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.

Study Arms

• Experimental: Resistance training with hydrolyzed collagen ingestion in healthy young men

  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.

  Intervention: Dietary Supplement: Resistance training with hydrolyzed collagen ingestion in healthy young men
• Experimental: Resistance training with hydrolyzed collagen ingestion in healthy young women
  The intervention procedure is the same as for Arm 1 except that the participants will be healthy young women (not men).
  Intervention: Dietary Supplement: Resistance training with hydrolyzed collagen ingestion in healthy young women

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: April 12, 2024): 23
• Original Actual Enrollment: Same as current
• Actual Study Completion Date: March 31, 2023
• Actual Primary Completion Date: September 29, 2021 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 39 Years (Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United Kingdom

Administrative Information

• NCT Number: NCT06372080
• Other Study ID Numbers: 19/SPS/054
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Liverpool John Moores University
• Original Responsible Party: Same as current
• Current Study Sponsor: Liverpool John Moores University
• Original Study Sponsor: Same as current
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: Liverpool John Moores University
• Verification Date: February 2024