ExerciseNCT06088108
Metabolic Responses to Exercise and Recovery
A study testing Cornell treadmill exercise protocol in people with Exercise and Metabolism, run by University College, London at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 8 to 57 yearsHealthy volunteers can take part
- Conditions the study is for
- Exercise, Metabolism
- What is being tested?
- Cornell treadmill exercise protocol
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Apr 2023to 31 Jan 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 57 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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)
Who cannot join
- 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).
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- 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.
- Not having reached menopause (for women aged 53-57 only).
Trial locations and contacts
1 site in 1 country.
Andy Galbraith, Dr contact
United Kingdom1 site, 1 recruiting
- Recruiting
University of East London SportsDock
London, E16 2RD
Evelyn Maniaki, Dr, +447481306193, evelyn.maniaki.20@ucl.ac.uk
Andy Galbraith, Dr, A.J.Galbraith@uel.ac.uk
About this study
Official title: Age and Sex Differences in the Metabolic Response to Exercise
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).
Read the detailed description
Before taking part, participants will be asked to complete an online inclusion questionnaire where the investigators will ask some questions about their health status, weight status, lifestyle, and medications to confirm that the participants are eligible and that it is safe for the participants to participate in the study. The investigators will record their consent electronically at this stage. If the participants are eligible and decide to take part in the study, the investigators will ask the participants to record their consent in writing before proceeding further.
The in-person part of the study will take place at the University Of East London SportsDock (4-6 University Way, London E16 2RD) and last 4-5 hours. No breakfast or coffee/tea should be consumed on the day of the visit, but the investigators will offer the participants breakfast. The participants will also need to not have had any alcohol, recreational drugs, or exercise for 24 hours.
On the day, the investigators will first measure their resting heart rate and blood pressure, collect body measurements (weight, height, waist circumference, hip circumference), and measure their body composition. The last thing the investigators will do before breakfast is to collect some samples. The investigators will collect two separate saliva samples using synthetic cotton swabs. After this, the investigators will collect a blood sample by venepuncture ("needle prick") from the adults only. This first part of the study will take 45-60 minutes.
Along with breakfast, the investigators will ask the participants to consume a dose of deuterium-labelled water: an odourless, tasteless, and safe water that will allow us to measure their total body water content. The investigators will also ask the participants to complete two short questionnaires assessing their mood, appetite, feeling of tiredness as well as verbal learning. This part will take approximately 30 minutes.
The researcher will then help the participants familiarise with the treadmill and associated equipment. The participants will wear a chest strap under their clothes and a special face mask which will be held in place by a head strap. These will measure their heart rate and everything the participants breathe in and out throughout the exercise challenge, respectively. The treadmill will start slowly to help the participants warm up and familiarise with the feeling of walking on it. After 2 minutes, the exercise challenge will begin. This will last for approximately 20 minutes, during which the treadmill will increase the speed and/or the incline every 2 minutes. It will feel like the participants are walking more briskly and more uphill, but it will not be too fast. The researcher will encourage the participants to complete the exercise challenge, as this will get the best response from their metabolism and give us the most accurate results. The participants will be able to stop the treadmill if the participants feel too exhausted to continue, feel faint or develop chest pain.
Right after the participants complete the exercise challenge, the investigators will collect a saliva sample using a synthetic cotton swab and a blood sample by venepuncture (adults only). The investigators will then ask the participants to complete the same two short questionnaires as before. This part will take approximately 30 minutes.
Finally, the researcher will allow the participants to relax and rest for about an hour. The investigators will then collect the last saliva samples using synthetic cotton swabs and blood samples by venepuncture (adults only). The participants will then complete the last iteration of the two short questionnaires.
- Conditions
- Exercise, Metabolism
- Being tested
- Cornell treadmill exercise protocol
- Keywords
- Exercise, Metabolism, Recovery, Metabolomics
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cornell treadmill exercise protocolDevice
Study participants are asked to undertake the Cornell treadmill exercise protocol which they complete to voluntary exhaustion.
| Study group | Role | What they receive |
|---|---|---|
| Single arm | Experimental | Study participants are asked to undertake the Cornell treadmill exercise protocol which they complete to voluntary exhaustion. Receives: Device: Cornell treadmill exercise protocol |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At baseline, immediately after exercise and one hour after exercise
Secondary outcomes (4)
Concentrations of hormones relating to life history functions using different assays
Concentrations of hormones measured in plasma or saliva at baseline, immediately after exercise and one hour after exercise using hormone assays. These hormone assays relate to the four life history functions, maintenance, defence, reproduction and growth. The following assays will be used: Bacteria killing and haemolytic complement assays in plasma to assess resistance to infection, total antioxidant capacity and malondialdehyde assays in plasma to assess oxidative stress, cortisol in saliva to assess stress response, interleukin-6 in saliva to assess inflammation, insulin growth factor and growth hormone assays in saliva to assess growth, oestradiol and testosterone in saliva to assess reproduction, as well as leptin, adiponectin and insulin in saliva to assess energy stores.
Measured: At baseline, immediately after exercise and one hour after exercise
Total body water measurement
Total body water using the doubly-labelled water method which involves collection of saliva before and 4 hours after consuming a dose of deuterium
Measured: Saliva collection before and 4 hours following consumption of deuterium
Verbal memory
Verbal memory assessment using the Rey Auditory Verbal Learning Test (RAVLT)
Measured: Baseline, immediately after exercise and one hour after exercise
Measurement of stress, mood, appetite perception, and the desire to eat different types of food
Assessment of stress, mood, appetite perception, and the desire to eat different types of food using a visual analogue scale published by Stubbs et al, 2000 and adapted online before breakfast, after breakfast as well as 15, 30, 45 and 60 minutes after exercise. This instrument incorporates a straight line in between two opposing statements defined as 'very little' to 'very much'. Participants are asked to mark a point in relation to their feelings at that moment.
Stubbs, R. J., Hughes, D. A., Johnstone, A. M., Rowley, E., Reid, C., Elia, M., et al. (2000). The use of visual analogue scales to assess motivation to eat in human subjects: A review of their reliability and validity with an evaluation of new hand-held computerized systems for temporal tracking of appetite ratings. British Journal of Nutrition, 84, 405e415.
Measured: Before breakfast, after breakfast as well as 15, 30, 45 and 60 minutes after exercise
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2023
- Study start1 Apr 2023
- Primary completion31 Jan 2024 (estimated)
- Study completion31 Jan 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ExerciseStudies of the same condition, open and under way.
- More trials run by University College, LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University College, London
- Sponsor type
- University, hospital or other
- Collaborators
- University of East London, Imperial College London
- Responsible party
- Sponsor
- Investigators
- Jonathan Wells, Professor, Principal investigator, University College, London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06088108
- Sponsor's protocol ID
- Metabex
- Status last verified
- Oct 2023
- First submitted
- 4 Oct 2023
- Last updated
- 18 Oct 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Researchers will have access to fully anonymised data.
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Age and Sex Differences in the Metabolic Response to Exercise
- ClinicalTrials.gov ID
- NCT06088108
- Acronym / sponsor ID
- Metabex
- Conditions
- Exercise, Metabolism
- Keywords
- Exercise, Metabolism, Recovery, Metabolomics
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- University College, LondonUniversity, hospital or other
- Collaborators
- University of East London, Imperial College London
- Study start
- 1 Apr 2023 (actual)
- Primary completion
- 31 Jan 2024 (estimated)
- Study completion
- 31 Jan 2024 (estimated)
- First posted
- 18 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
Before taking part, participants will be asked to complete an online inclusion questionnaire where the investigators will ask some questions about their health status, weight status, lifestyle, and medications to confirm that the participants are eligible and that it is safe for the participants to participate in the study. The investigators will record their consent electronically at this stage. If the participants are eligible and decide to take part in the study, the investigators will ask the participants to record their consent in writing before proceeding further.
The in-person part of the study will take place at the University Of East London SportsDock (4-6 University Way, London E16 2RD) and last 4-5 hours. No breakfast or coffee/tea should be consumed on the day of the visit, but the investigators will offer the participants breakfast. The participants will also need to not have had any alcohol, recreational drugs, or exercise for 24 hours.
On the day, the investigators will first measure their resting heart rate and blood pressure, collect body measurements (weight, height, waist circumference, hip circumference), and measure their body composition. The last thing the investigators will do before breakfast is to collect some samples. The investigators will collect two separate saliva samples using synthetic cotton swabs. After this, the investigators will collect a blood sample by venepuncture ("needle prick") from the adults only. This first part of the study will take 45-60 minutes.
Along with breakfast, the investigators will ask the participants to consume a dose of deuterium-labelled water: an odourless, tasteless, and safe water that will allow us to measure their total body water content. The investigators will also ask the participants to complete two short questionnaires assessing their mood, appetite, feeling of tiredness as well as verbal learning. This part will take approximately 30 minutes.
The researcher will then help the participants familiarise with the treadmill and associated equipment. The participants will wear a chest strap under their clothes and a special face mask which will be held in place by a head strap. These will measure their heart rate and everything the participants breathe in and out throughout the exercise challenge, respectively. The treadmill will start slowly to help the participants warm up and familiarise with the feeling of walking on it. After 2 minutes, the exercise challenge will begin. This will last for approximately 20 minutes, during which the treadmill will increase the speed and/or the incline every 2 minutes. It will feel like the participants are walking more briskly and more uphill, but it will not be too fast. The researcher will encourage the participants to complete the exercise challenge, as this will get the best response from their metabolism and give us the most accurate results. The participants will be able to stop the treadmill if the participants feel too exhausted to continue, feel faint or develop chest pain.
Right after the participants complete the exercise challenge, the investigators will collect a saliva sample using a synthetic cotton swab and a blood sample by venepuncture (adults only). The investigators will then ask the participants to complete the same two short questionnaires as before. This part will take approximately 30 minutes.
Finally, the researcher will allow the participants to relax and rest for about an hour. The investigators will then collect the last saliva samples using synthetic cotton swabs and blood samples by venepuncture (adults only). The participants will then complete the last iteration of the two short questionnaires.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single arm | Experimental | Device: Cornell treadmill exercise protocolStudy participants are asked to undertake the Cornell treadmill exercise protocol which they complete to voluntary exhaustion. |
Who may qualify
- Ages
- 8 to 57 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (16 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cornell treadmill exercise protocolStudy participants are asked to undertake the Cornell treadmill exercise protocol which they complete to voluntary exhaustion. | Device | Single arm |
Primary outcome
Concentration of molecules relating to energy metabolism using targeted liquid chromatography-mass spectrometry assays
Time frame: At baseline, immediately after exercise and one hour after exercise
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.
4 secondary outcomes
Concentrations of hormones relating to life history functions using different assays
Time frame: At baseline, immediately after exercise and one hour after exercise
Total body water measurement
Time frame: Saliva collection before and 4 hours following consumption of deuterium
Verbal memory
Time frame: Baseline, immediately after exercise and one hour after exercise
Measurement of stress, mood, appetite perception, and the desire to eat different types of food
Time frame: Before breakfast, after breakfast as well as 15, 30, 45 and 60 minutes after exercise
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Oct 2023.
- Individual participant dataSharing planned: Yes. Researchers will have access to fully anonymised data.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andy Galbraith, Dr contact
Jonathan Wells, Professor principal investigator
University College, London
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cornell treadmill exercise protocol in people with Exercise and Metabolism, run by University College, London at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Evelyn Maniaki, Dr (+447481306193, evelyn.maniaki.20@ucl.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Concentration of molecules relating to energy metabolism using targeted liquid chromatography-mass spectrometry assays (time frame: At baseline, immediately after exercise and one hour after exercise). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Oct 2023.