Cardiovascular DiseasesNCT05742373
Role of Fasted Exercise on Improving Cardiometabolic Health
A study testing Exercise training in the fasted state and Exercise training in the fed state in people with Cardiovascular Diseases and Diabetes Mellitus, Type 2, run by Manchester Metropolitan University at 1 site in United Kingdom.
Trial summary
The aim of this randomised control trial is to investigate the role of fasted exercise on cardiometabolic health. Participants will be assigned to one of three conditions, fasted exercise, fed exercise and control (no exercise). Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Diseases, Diabetes Mellitus, Type 2, Obesity
- What is being tested?
- Exercise training in the fasted state and Exercise training in the fed state
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Mar 2023to May 2025
- 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 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male or female
- Non-smokers
- Physically inactive (partake in no more than one exercise session per week on average)
- Body mass index >18.5 kg/m2
- Healthy as assessed by medical screening questionnaire
- Prior recipient of local anaesthetic with no known adverse effects, no known hypersensitivity or no other health issue that may constrain the administration of lidocaine hydrochloride
- Free from musculoskeletal injury and able to perform cycling exercise
- Capacity to give informed consent
Who cannot join
- Regular exerciser
- BMI < 18.5 kg/m2
- Pregnant
- Allergy or intolerances to test meal products/ingredients (such as wheat or dairy products).
- Recent major body weight change (+/- 3 kg in the past month)
- Known hypersensitivity to Lidocaine Hydrochloride
Show all 14Show fewer
- Cardiovascular disease - complete heart block or hypovolaemia
- Adam's-Stokes Syndrome
- Wolff-Parkinson-White Syndrome
- Porphyria
- Epilepsy
- Myasthenia Gravis
- Other chronic medical condition or diagnosis including respiratory (eg asthma), endocrine, cardiovascular, neuromuscular disorders.
- Taking medications or receiving treatment that may constrain the administration of lidocaine or local anaesthesia.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
Manchester Metropolitan University
Manchester, Greater Manchester, M1 5GD
Adora Yau, PhD, +44(0)1612475504, a.yau@mmu.ac.uk
Gethin Evans, PhD, +44(0)1612471208, gethin.evans@mmu.ac.uk
About this study
Official title: Investigating the Role of Fasted Exercise on Improving Cardiometabolic Health; a Potential Mediatory Role of Sirtuins
The aim of this randomised control trial is to investigate the role of fasted exercise on cardiometabolic health. Participants will be assigned to one of three conditions, fasted exercise, fed exercise and control (no exercise). Participants in the exercise groups will complete four weeks of moderate intensity cycling exercise, three times per week, either in the fasted or fed state according to their group assignment. Experimental trials involving anthropometric and cardiometabolic disease risk factor measurements as well as metabolic responses to a subsequent meal ingestion following exercise will be compared pre-intervention and post intervention.
Read the detailed description
The aim of this study is to investigate the effect of fasted exercise on cardiometabolic health and the potential mediatory role of sirtuins.
The objectives are to investigate:
- The effect of a single bout of fasted exercise on acute metabolic responses following a high fat meal.
- The effect of four weeks of fasted exercise training on cardiovascular and metabolic disease risk factors.
- The effect of four weeks of fasted exercise training on circulating levels and subcutaneous adipose tissue gene expression of SIRT1, SIRT3 and SIRT6.
A randomised control trial will be conducted with volunteers allocated under the conditions of a) no exercise (control), b) fasted exercise training (FASTEX) and c) fed exercise training (FEDEX). The pre- and post-intervention visits will consist of 50 minutes of cycling at a moderate exercise intensity for both the FASTEX and FEDEX groups. The control group would not perform any exercise. The FASTEX group will perform the exercise in the fasted state, whilst the FEDEX and control groups will be fed a standardised breakfast meal one hour in advance of the exercise period. Following the exercise period, the participants will be fed a high fat meal and metabolic responses to the meal will be measured for four hours. Multiple blood samples will be obtained as well as a sample of subcutaneous adipose (fat) tissue. The FASTEX and FEDEX groups will then complete four weeks of moderate intensity continuous exercise training, either fasted or fed according to their group, on three days per week whilst the control group will maintain their normal sedentary lifestyle. All participants will return to the laboratory for post-intervention testing at the end of the four weeks with the same protocols and measurements as the pre-intervention testing.
- Conditions
- Cardiovascular Diseases, Diabetes Mellitus, Type 2, Obesity
- Being tested
- Exercise training in the fasted state, Exercise training in the fed state
- Keywords
- Cardiovascular disease, Diabetes Mellitus, Obesity, Cardiometabolic health, Exercise, Fasted, Sirtuins
- Medical subject headings
- Cardiovascular Diseases, Diabetes Mellitus, Type 2, Obesity, Diabetes Mellitus, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise training in the fasted stateOther
Four weeks of moderate intensity cycling exercise, three times a week without eating breakfast meal
Exercise training in the fed stateOther
Four weeks of moderate intensity cycling exercise, three times a week, after eating breakfast meal
| Study group | Role | What they receive |
|---|---|---|
| Fasted exercise | Experimental | Exercise training in the fasted state Receives: Other: Exercise training in the fasted state |
| Fed exercise | Active comparator | Exercise training in the fed state Receives: Other: Exercise training in the fed state |
| Control | No intervention | No exercise training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in circulating concentrations of key metabolic markers following a high fat lunch meal
Serum concentrations of clinical chemistry blood analytes (glucose, triglycerides, cholesterol)
Measured: 9 blood samples collected at pre-meal ingestion then every 30 min after ingestion for four hours
Changes in circulating concentrations of key metabolic markers during the experimental trial day
Serum concentrations of clinical chemistry blood analytes (glucose, triglycerides, cholesterol)
Measured: 12 blood samples collected at 0 (baseline), 75 (pre-exercise), 125 (immediately post-exercise), 155 min (pre-meal ingestion) then every 30 min after ingestion for four hours
Area under the circulating concentration versus time curve (AUC) of key metabolic markers following a high fat lunch meal
Total responses of clinical chemistry blood analytes (glucose, triglycerides, cholesterol)
Measured: 4.5 hours
Changes in cardiovascular and metabolic disease biochemistry risk factors
Fasted serum concentrations of clinical chemistry blood analytes (glucose, blood lipids, inflammatory markers)
Measured: 4 weeks (pre and post intervention)
Changes in cardiovascular disease physiological risk factors
Systolic and diastolic blood pressure and calculation of mean arterial pressure using systolic and diastolic values
Measured: 4 weeks (pre and post intervention)
Changes in concentration of sirtuin molecules
Serum concentrations of sirtuins
Measured: 4 weeks (pre and post intervention)
Changes in sirtuin molecule gene expression
Adipose tissue gene expression of sirtuins
Measured: 4 weeks (pre and post intervention)
Changes in sirtuin molecule tissue expression
Adipose tissue expression and cellular localisation of sirtuins
Measured: 4 weeks (pre and post intervention)
Secondary outcomes (10)
Changes in cardiovascular and metabolic disease anthropometric risk factors
Waist circumference, hip circumference and waist:hip ratio
Measured: 4 weeks (pre and post intervention)
Change in body composition
Body fat percentage measured using bioelectrical impedance analysis
Measured: 4 weeks (pre and post intervention)
Change in body mass
Body mass in kilograms
Measured: 4 weeks (pre and post intervention)
Change in substrate oxidation during the experimental trial day
Carbohydrate and fat oxidation through indirect calorimetry
Measured: 17 measurements at 0 (baseline), 15 (post-breakfast meal period), 45 (30 min post-breakfast meal period), 75 (pre-exercise), every 10 min during exercise, 155 (pre-meal ingestion), then every 30 min for four hours.
Heart rate response to exercise
Heart rate during exercise in the experimental trial using telemetry
Measured: At rest before exercise then every 5 min during 50 min cycle exercise
Perceived exertion
Rating of perceived exertion of exercise in the experimental trial using Borg scale
Measured: Every 5 min during 50 min cycle exercise
Change in physical activity levels
Physical activity energy expenditure during the intervention period
Measured: Daily for 4 weeks
Change in physical activity duration
Amount of time spent performing physical activity at different intensities (low, moderate, high) during the intervention period
Measured: Daily for 4 weeks
Change in energy intake
Energy intake using weighed food diary record during the intervention period
Measured: Daily for 4 weeks
Change in dietary nutritional intake
Macronutrient (carbohydrate, fat, protein) composition of food intake using weighed food diary record during the intervention period
Measured: Daily for 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2023
- Study start1 Mar 2023
- Primary completionApr 2025 (estimated)
- Study completionMay 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular DiseasesStudies of the same condition, open and under way.
- 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomised control
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Manchester Metropolitan University
- Sponsor type
- University, hospital or other
- Collaborators
- European Society for Clinical Nutrition and Metabolism
- Responsible party
- Principal investigator, Adora Yau, Manchester Metropolitan University
- Investigators
- Adora Yau, PhD, Principal investigator, Manchester Metropolitan UniversityGethin Evans, PhD, Study director, Manchester Metropolitan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05742373
- Sponsor's protocol ID
- FastExTrainESPEN2022
- Status last verified
- Mar 2024
- First submitted
- 27 Jan 2023
- Last updated
- 7 Mar 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Planned communication of group results at a scientific conference. Planned publication in a scientific peer reviewed journal. Participant level data is not expected to be available as this complies with the conditions of the ethical approval granted for this study.
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating the Role of Fasted Exercise on Improving Cardiometabolic Health; a Potential Mediatory Role of Sirtuins
- ClinicalTrials.gov ID
- NCT05742373
- Acronym / sponsor ID
- FastExTrainESPEN2022
- Conditions
- Cardiovascular Diseases, Diabetes Mellitus, Type 2, Obesity
- Keywords
- Cardiovascular disease, Diabetes Mellitus, Obesity, Cardiometabolic health, Exercise, Fasted, Sirtuins
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Manchester Metropolitan UniversityUniversity, hospital or other
- Collaborators
- European Society for Clinical Nutrition and Metabolism
- Study start
- 1 Mar 2023 (actual)
- Primary completion
- Apr 2025 (estimated)
- Study completion
- May 2025 (estimated)
- First posted
- 24 Feb 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.
The aim of this randomised control trial is to investigate the role of fasted exercise on cardiometabolic health. Participants will be assigned to one of three conditions, fasted exercise, fed exercise and control (no exercise). Participants in the exercise groups will complete four weeks of moderate intensity cycling exercise, three times per week, either in the fasted or fed state according to their group assignment. Experimental trials involving anthropometric and cardiometabolic disease risk factor measurements as well as metabolic responses to a subsequent meal ingestion following exercise will be compared pre-intervention and post intervention.
Detailed description
The aim of this study is to investigate the effect of fasted exercise on cardiometabolic health and the potential mediatory role of sirtuins.
The objectives are to investigate:
- The effect of a single bout of fasted exercise on acute metabolic responses following a high fat meal.
- The effect of four weeks of fasted exercise training on cardiovascular and metabolic disease risk factors.
- The effect of four weeks of fasted exercise training on circulating levels and subcutaneous adipose tissue gene expression of SIRT1, SIRT3 and SIRT6.
A randomised control trial will be conducted with volunteers allocated under the conditions of a) no exercise (control), b) fasted exercise training (FASTEX) and c) fed exercise training (FEDEX). The pre- and post-intervention visits will consist of 50 minutes of cycling at a moderate exercise intensity for both the FASTEX and FEDEX groups. The control group would not perform any exercise. The FASTEX group will perform the exercise in the fasted state, whilst the FEDEX and control groups will be fed a standardised breakfast meal one hour in advance of the exercise period. Following the exercise period, the participants will be fed a high fat meal and metabolic responses to the meal will be measured for four hours. Multiple blood samples will be obtained as well as a sample of subcutaneous adipose (fat) tissue. The FASTEX and FEDEX groups will then complete four weeks of moderate intensity continuous exercise training, either fasted or fed according to their group, on three days per week whilst the control group will maintain their normal sedentary lifestyle. All participants will return to the laboratory for post-intervention testing at the end of the four weeks with the same protocols and measurements as the pre-intervention testing.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Randomised control
| Arm | Type | Receives |
|---|---|---|
| Fasted exercise | Experimental | Other: Exercise training in the fasted stateExercise training in the fasted state |
| Fed exercise | Active comparator | Other: Exercise training in the fed stateExercise training in the fed state |
| Control | No intervention | –No exercise training |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Male or female
- Non-smokers
- Physically inactive (partake in no more than one exercise session per week on average)
- Body mass index >18.5 kg/m2
- Healthy as assessed by medical screening questionnaire
Key exclusion criteria (14 listed)
- Regular exerciser
- BMI < 18.5 kg/m2
- Pregnant
- Allergy or intolerances to test meal products/ingredients (such as wheat or dairy products).
- Recent major body weight change (+/- 3 kg in the past month)
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 |
|---|---|---|
| Exercise training in the fasted stateFour weeks of moderate intensity cycling exercise, three times a week without eating breakfast meal | Other | Fasted exercise |
| Exercise training in the fed stateFour weeks of moderate intensity cycling exercise, three times a week, after eating breakfast meal | Other | Fed exercise |
Primary outcome
Changes in circulating concentrations of key metabolic markers following a high fat lunch meal
Time frame: 9 blood samples collected at pre-meal ingestion then every 30 min after ingestion for four hours
Serum concentrations of clinical chemistry blood analytes (glucose, triglycerides, cholesterol)
Changes in circulating concentrations of key metabolic markers during the experimental trial day
Time frame: 12 blood samples collected at 0 (baseline), 75 (pre-exercise), 125 (immediately post-exercise), 155 min (pre-meal ingestion) then every 30 min after ingestion for four hours
Serum concentrations of clinical chemistry blood analytes (glucose, triglycerides, cholesterol)
Area under the circulating concentration versus time curve (AUC) of key metabolic markers following a high fat lunch meal
Time frame: 4.5 hours
Total responses of clinical chemistry blood analytes (glucose, triglycerides, cholesterol)
Changes in cardiovascular and metabolic disease biochemistry risk factors
Time frame: 4 weeks (pre and post intervention)
Fasted serum concentrations of clinical chemistry blood analytes (glucose, blood lipids, inflammatory markers)
Changes in cardiovascular disease physiological risk factors
Time frame: 4 weeks (pre and post intervention)
Systolic and diastolic blood pressure and calculation of mean arterial pressure using systolic and diastolic values
Changes in concentration of sirtuin molecules
Time frame: 4 weeks (pre and post intervention)
Serum concentrations of sirtuins
Changes in sirtuin molecule gene expression
Time frame: 4 weeks (pre and post intervention)
Adipose tissue gene expression of sirtuins
Changes in sirtuin molecule tissue expression
Time frame: 4 weeks (pre and post intervention)
Adipose tissue expression and cellular localisation of sirtuins
10 secondary outcomes
Changes in cardiovascular and metabolic disease anthropometric risk factors
Time frame: 4 weeks (pre and post intervention)
Change in body composition
Time frame: 4 weeks (pre and post intervention)
Change in body mass
Time frame: 4 weeks (pre and post intervention)
Change in substrate oxidation during the experimental trial day
Time frame: 17 measurements at 0 (baseline), 15 (post-breakfast meal period), 45 (30 min post-breakfast meal period), 75 (pre-exercise), every 10 min during exercise, 155 (pre-meal ingestion), then every 30 min for four hours.
Heart rate response to exercise
Time frame: At rest before exercise then every 5 min during 50 min cycle exercise
Perceived exertion
Time frame: Every 5 min during 50 min cycle exercise
Change in physical activity levels
Time frame: Daily for 4 weeks
Change in physical activity duration
Time frame: Daily for 4 weeks
Change in energy intake
Time frame: Daily for 4 weeks
Change in dietary nutritional intake
Time frame: Daily for 4 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2024.
- Individual participant dataSharing planned: No. Planned communication of group results at a scientific conference. Planned publication in a scientific peer reviewed journal. Participant level data is not expected to be available as this complies with the conditions of the ethical approval granted for this study.
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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.
Adora Yau, PhD principal investigator
Manchester Metropolitan University
Gethin Evans, PhD study director
Manchester Metropolitan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise training in the fasted state and Exercise training in the fed state in people with Cardiovascular Diseases and Diabetes Mellitus, Type 2, run by Manchester Metropolitan University 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 8 inclusion and 14 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 7 Mar 2024. 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 Adora Yau, PhD (+44(0)1612475504, a.yau@mmu.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in circulating concentrations of key metabolic markers following a high fat lunch meal (time frame: 9 blood samples collected at pre-meal ingestion then every 30 min after ingestion for four hours). The study lists 8 primary outcomes in all. 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 7 Mar 2024.