NCT05932771

Brief Summary

This study aimed to investigate the effect of different doses of hydrolyzed collagen (HC) with resistance exercise (RE) on whole body collagen synthesis in healthy young and older males and females.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
21

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2019

Longer than P75 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 1, 2019

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2019

Completed
3.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2023

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

May 26, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

July 6, 2023

Completed
Last Updated

July 6, 2023

Status Verified

June 1, 2023

Enrollment Period

8 months

First QC Date

May 26, 2023

Last Update Submit

June 27, 2023

Conditions

Keywords

Hydolyzed collagenResistance exerciseCollagen synthesisProlineGlycine

Outcome Measures

Primary Outcomes (3)

  • Change in a marker of collagen synthesis

    Serum procollagen type Ⅰ N-terminal propeptide (PⅠNP) concentrations were measured following 0 grams, 15 grams or 30 grams hydrolyzed collagen (HC) intake with resistnace exercise (RE) during all trials.

    at rest immediately prior to HC ingestion, 0.5-hour post RE, 1-hour post RE, 2-hour post RE, 4-hour post RE and 6-hour post RE

  • Change in a marker of collagen breakdown

    Plasma β-isomerized C-terminal telopeptide of type I collagen (β-CTX) concentrations were measured following 0 grams, 15 grams or 30 grams hydrolyzed collagen (HC) intake with resistnace exercise (RE) during all trials.

    at rest immediately prior to HC ingestion and 6-hour post RE

  • Changes in amino acids concentrations in blood

    Concentration of serum amino acids that constitute collagen was measured following 0 grams, 15 grams or 30 grams hydrolyzed collagen (HC) intake with resistnace exercise (RE) during all trials.

    at rest immediately prior to HC ingestion, 0.5-hour post HC ingestion, 1-hour post HC ingestion, 0.5-hour post RE, 1-hour post RE, 2-hour post RE, 4-hour post RE and 6-hour post RE

Secondary Outcomes (1)

  • Estrogen concentrations in women in each trial

    at rest immediately prior to HC ingestion

Study Arms (4)

1.Trial for young male participants: Consuming hydrolyzed collagen (HC) with reistance exercise

EXPERIMENTAL

Young male participants consumed one of three different HC doses (0 grams, 15 grams, or 30 grams) with 4 sets of 10 repetitions of barbell back squat exercise at 10-repetition maximum load in a random order and a seven-day wash-out period interspersed between each trial.

Dietary Supplement: Experimental: Consumption of three different doses of hydrolyzed collagen (HC) with reistance exercise

2.Trial for young female participant: Consuming hydrolyzed collagen (HC) with reistance exercise

EXPERIMENTAL

The intervention procedure is exactly same as Arm 1 except for the number of visits. Young female participant was asked to visit the laboratory on four occasions during two consecutive months. Therefore, there were two trials in each month, where female participants' estrogen level was lower (i.e., onset of menses) or higher (i.e., ovulation). Dates for the trials were determined based on self-report of onset of menses and previous menstrual cycle length.

Dietary Supplement: Experimental: Consumption of two different doses of hydrolyzed collagen (HC) with reistance exercise

3.Trial for older male participants: Consuming hydrolyzed collagen (HC) with reistance exercise

EXPERIMENTAL

The age range of older male participants was 40 - 65 years. The intervention procedure is exactly same as Arm 1

Dietary Supplement: Experimental: Consumption of three different doses of hydrolyzed collagen (HC) with reistance exercise

4.Trial for older female participants: Consuming hydrolyzed collagen (HC) with reistance exercise

EXPERIMENTAL

The age range of older female participants was 40 - 65 years. The intervention procedure is exactly same as Arm 2

Dietary Supplement: Experimental: Consumption of two different doses of hydrolyzed collagen (HC) with reistance exercise

Interventions

Each trial lasts for seven hours and while participants consumed HC, performed resistance exercise and rested, 10 x 5 mL blood samples were collected from a superficial forearm vein using a cannula. All trials were performed at the same time of day (08:00 - 15:00). Different doses of HC (0 grams, 15 grams and 30 grams) and 50 milligrams vitamin C were dissolved with 250 milliliter water in an opaque bottle. To match calories of 30 grams HC, 34.1 grams and 15.4 grams maltodextrin was used in 0 grams HC and 15 grams HC respectively. Also to mask any potential difference in HC doses, 4 grams non-caloric sweetener was used in all HC doses. The details of nutritoinal supplements used are as follows: Hydrolysed collagen (Myprotein, Cheshire, UK), Vitamin C powder (Holland and Barrett Retail Limited, Warwickshire, UK), Maltodextrin (Myprotein, Cheshire, UK), and Non-caloric sweetener (Truvia®, SilverSpoon, London, UK)

Also known as: Resistance exercise and collagen dose-response for male participants
1.Trial for young male participants: Consuming hydrolyzed collagen (HC) with reistance exercise3.Trial for older male participants: Consuming hydrolyzed collagen (HC) with reistance exercise

Each trial lasts for seven hours and while participants consumed HC, performed resistance exercise and rested, 10 x 5 mL blood samples were collected from a superficial forearm vein using a cannula. All trials were performed at the same time of day (08:00 - 15:00). Different doses of HC (0 grams and 30 grams) and 50 milligrams vitamin C were dissolved with 250 milliliter water in an opaque bottle. To match calories of 30 grams HC, 34.1 grams maltodextrin was used in 0 grams HC. Also to mask any potential difference in HC doses, 4 grams non-caloric sweetener was used in all HC doses. The details of nutritoinal supplements used are as follows: Hydrolysed collagen (Myprotein, Cheshire, UK), Vitamin C powder (Holland and Barrett Retail Limited, Warwickshire, UK), Maltodextrin (Myprotein, Cheshire, UK), and Non-caloric sweetener (Truvia®, SilverSpoon, London, UK)

Also known as: Resistance exercise and collagen dose-response for female participants
2.Trial for young female participant: Consuming hydrolyzed collagen (HC) with reistance exercise4.Trial for older female participants: Consuming hydrolyzed collagen (HC) with reistance exercise

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • At least 12 months experienced in resistance exercise (regular back squat experience)
  • Free from musculoskeletal injury
  • Nullipara (a woman who has never given birth) (only for young female participatns)

You may not qualify if:

  • Having a history of patellar tendon pathology
  • Vegan
  • Consumed nutritional supplements or medication purported to have beneficial effects on muscle-tendon properties (e.g. antioxidants, protein, etc.)
  • Had a sustained a lower limb injury in the previous six months
  • Smoker/vaper
  • \<18 or \>40 years old (only for young participants)
  • \<40 ro \>65 years old (only for older participants)
  • Having an irregular menstrual cycle (only for young female participants)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dr Rob Erskine

Liverpool, L3 3AF, United Kingdom

Location

Study Officials

  • Robert M. Erskine, PhD

    Liverpool John Moores University

    STUDY DIRECTOR
  • Joonsung Lee, MSc

    Liverpool John Moores University

    PRINCIPAL INVESTIGATOR
  • Christopher Nulty

    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 commencing each experimental trial, a laboratory technician (independent to the study) made up the three doses of hydrolyzed collagen (HC) and randomly assigned the order of HC dose (Excel 2016, Microsoft, Washington, USA) for each participant. Also, for each trial, the technician recorded the date, randomly allocated trial number (1, 2 or 3) and corresponding HC dose to blind the investigator.
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Model Details: A double-blind, randomised cross-over design
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Reader in Neuromuscular Physiology

Study Record Dates

First Submitted

May 26, 2023

First Posted

July 6, 2023

Study Start

January 1, 2019

Primary Completion

August 30, 2019

Study Completion

April 30, 2023

Last Updated

July 6, 2023

Record last verified: 2023-06

Data Sharing

IPD Sharing
Will not share

No plan to share

Locations