NCT06088108

Brief Summary

Exercise benefits health through diverse metabolic processes and is central to healthy ageing. However, intense exercise also challenges the body, causing cellular damage that must be repaired. This means that we need to identify the level of exercise that can optimise health, and this level might potentially differ by age and sex. Our research aims to tackle this question, by studying the metabolic responses of the body both to exercise and during the subsequent recovery in 48 healthy and active participants between the ages of 8-10, 23-27 and 53-57. Participants will complete an inclusion questionnaire and, if eligible, be invited to visit the exercise laboratory 4-5-hours. We will collect questionnaire data and body measurements before participants undertake exercise on a treadmill. Biological samples (blood from adults only and saliva from everyone) will be collected at three time points (before, right after and one hour after exercise).

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
48

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

April 1, 2023

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

October 4, 2023

Completed
14 days until next milestone

First Posted

Study publicly available on registry

October 18, 2023

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2024

Completed
Last Updated

October 18, 2023

Status Verified

October 1, 2023

Enrollment Period

10 months

First QC Date

October 4, 2023

Last Update Submit

October 11, 2023

Conditions

Keywords

ExerciseMetabolismRecoveryMetabolomics

Outcome Measures

Primary Outcomes (1)

  • Concentration of molecules relating to energy metabolism using targeted liquid chromatography-mass spectrometry assays

    Concentrations of metabolites measured in plasma and saliva at baseline, immediately after exercise and one hour after exercise using targeted liquid chromatography-mass spectrometry (LCMS) assays. These include amine, ion-pairing, lipid, fatty acid, acylcarnitine and oxylipin assays.

    At baseline, immediately after exercise and one hour after exercise

Secondary Outcomes (4)

  • Concentrations of hormones relating to life history functions using different assays

    At baseline, immediately after exercise and one hour after exercise

  • Total body water measurement

    Saliva collection before and 4 hours following consumption of deuterium

  • Verbal memory

    Baseline, immediately after exercise and one hour after exercise

  • Measurement of stress, mood, appetite perception, and the desire to eat different types of food

    Before breakfast, after breakfast as well as 15, 30, 45 and 60 minutes after exercise

Study Arms (1)

Single arm

EXPERIMENTAL

Study participants are asked to undertake the Cornell treadmill exercise protocol which they complete to voluntary exhaustion.

Device: Cornell treadmill exercise protocol

Interventions

Study participants are asked to undertake the Cornell treadmill exercise protocol which they complete to voluntary exhaustion.

Single arm

Eligibility Criteria

Age8 Years - 57 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Aged 8-10, 23-27 or 53-57
  • Considered healthy without a disease, disability or other condition that would impair participation in physical activity.
  • Considered active.
  • A body mass index within the ranges of 19 to 24.5 (adults) or the 2nd and 99th percentile (children)

You may not qualify if:

  • Outside required age brackets
  • Having a disease, disability or other condition that would impair participation in physical activity.
  • Having an implanted cardiac pacemaker, defibrillator, or other electronic medical devices.
  • Receiving prescription medication one or more days every week over the past 3 months (some medications are permitted).
  • Related by blood to another participant.
  • Not willing at the time of recruitment to undergo blood sampling (adults only).
  • Pregnancy/breastfeeding (adults only).
  • Being a professional athlete.
  • Not being physically active.
  • Being a shift worker (night shift work for three or more days per week on more than two occasions in the six months before the visit day; adults only).
  • Recent weight loss of more than 5% of weight in the last 6 months.
  • Having a body mass index outside the range of 19 to 24.5 (adults) or outside the 2nd and 99th percentile (children)
  • Smoking/vaping.
  • Alcohol intake above a UK National Health Service (NHS) questionnaire cut-off.
  • Regular use of recreational drugs.
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of East London SportsDock

London, E16 2RD, United Kingdom

RECRUITING

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Jonathan Wells, Professor

    University College, London

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Andy Galbraith, Dr

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 4, 2023

First Posted

October 18, 2023

Study Start

April 1, 2023

Primary Completion

January 31, 2024

Study Completion

January 31, 2024

Last Updated

October 18, 2023

Record last verified: 2023-10

Data Sharing

IPD Sharing
Will share

Researchers will have access to fully anonymised data.

Shared Documents
STUDY PROTOCOL, SAP, CSR
Time Frame
It will be available on UCL's repository from March 2025 onwards.

Locations