NCT06236659

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 middle-aged males and females.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2019

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2021

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2023

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

January 24, 2024

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 1, 2024

Completed
Last Updated

February 2, 2024

Status Verified

January 1, 2024

Enrollment Period

1.8 years

First QC Date

January 24, 2024

Last Update Submit

January 31, 2024

Conditions

Keywords

Hydrolyzed collagenResistance ExerciseCollagen SynthesisProlineGlycine

Outcome Measures

Primary Outcomes (2)

  • 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 resistance exercise (RE) during all interventions.

    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 resistance exercise (RE) during all interventions.

    At rest, immediately prior to HC ingestion, 0.5-hour post RE, 2-hour post RE and 6-hour post RE

Secondary Outcomes (2)

  • Estrogen concentrations in women in each trial

    At rest immediately prior to HC ingestion

  • Changes in amino acids concentrations in blood

    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

Study Arms (2)

Intervention for middle-aged men: Consumption of hydrolyzed collagen (HC) with resistance exercise

EXPERIMENTAL

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

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

Intervention for middle-aged women: Consumption of hydrolyzed collagen (HC) with resistance exercise

EXPERIMENTAL

The intervention procedure is exactly same as Arm 1 except for the number of visits and doses of HC. Middle-aged female participants were asked to visit the laboratory on the day of highest oestrogen (i.e. ovulation) and provided with 0 g or 30 g HC. Dates for the trials were determined based on self-report of onset of menses and previous menstrual cycle length.

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

Interventions

Each intervention 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 interventions 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 dietary 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 middle-aged male participants
Intervention for middle-aged men: Consumption of hydrolyzed collagen (HC) with resistance exercise

Each intervention 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 interventions 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 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 dietary 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 middle-aged female participants
Intervention for middle-aged women: Consumption of hydrolyzed collagen (HC) with resistance exercise

Eligibility Criteria

Age40 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 (including weekly lower body exercise)
  • Free from musculoskeletal injury

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
  • Having reached menopause (only for middle-aged 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

    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 intervention, 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 intervention, 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: Double-blind, randomized cross-over design
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 24, 2024

First Posted

February 1, 2024

Study Start

December 1, 2019

Primary Completion

September 30, 2021

Study Completion

September 30, 2023

Last Updated

February 2, 2024

Record last verified: 2024-01

Data Sharing

IPD Sharing
Will not share

No plan to share

Locations