NCT06402890

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
42

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2021

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

July 1, 2021

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 13, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 13, 2023

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

April 17, 2024

Completed
20 days until next milestone

First Posted

Study publicly available on registry

May 7, 2024

Completed
Last Updated

May 7, 2024

Status Verified

May 1, 2024

Enrollment Period

2 years

First QC Date

April 17, 2024

Last Update Submit

May 2, 2024

Conditions

Keywords

Hydrolyzed collagenMiddle-ageResistance trainingTendon properties

Outcome Measures

Primary Outcomes (12)

  • m. vastus lateralis thickness (in millimetres)

    Ultrasonography was used to determine changes in muscle thicknessprotocols

    8-12 weeks' training and nutrition intervention

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

Study Arms (2)

Resistance training with hydrolyzed collagen in health, active, middle-aged men

EXPERIMENTAL

Middle-aged, trained males completed 12-weeks of a supervised, progressive resistance training programme while consuming 30 g of hydrolyzed collagen or a calorie matched placebo beverage.

Dietary Supplement: Resistance training with collagen supplementation

Resistance training with hydrolyzed collagen in healthy, active, middle-aged women

EXPERIMENTAL

Middle-aged, trained females completed 8-weeks of a supervised, progressive resistance training programme while consuming 30 g of hydrolyzed collagen or a calorie matched placebo beverage

Dietary Supplement: Resistance training with collagen supplementation

Interventions

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.

Resistance training with hydrolyzed collagen in health, active, middle-aged menResistance training with hydrolyzed collagen in healthy, active, middle-aged women

Eligibility Criteria

Age35 Years - 59 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dr Rob Erskine

Liverpool, 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 Officials

  • Robert M Erskine, PhD

    Liverpool John Moores University

    STUDY DIRECTOR
  • Christopher D Nulty, MSc

    Liverpool John Moores University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
Before the intervention commenced, a laboratory technician (independent to the study) made up the dry ingestions all the 30 g doses of hydrolyzed collagen (HC), and calorie matched placebo and stored in sachets. These sachets were labelled as with the participants name. The technician randomly assigned either HC or placebo to participants who were pair matched (Excel 2016, Microsoft, Washington, USA). The groupings and contents of the sachets were unknown to the researcher and the participants, who all remained blinded until data collection and analysis were complete.
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Model Details: Double-blind, placebo-controlled trial
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 17, 2024

First Posted

May 7, 2024

Study Start

July 1, 2021

Primary Completion

July 13, 2023

Study Completion

July 13, 2023

Last Updated

May 7, 2024

Record last verified: 2024-05

Data Sharing

IPD Sharing
Will not share

Locations