- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05742373
Role of Fasted Exercise on Improving Cardiometabolic Health
Investigating the Role of Fasted Exercise on Improving Cardiometabolic Health; a Potential Mediatory Role of Sirtuins
Study Overview
Status
Intervention / Treatment
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 Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Adora Yau, PhD
- Phone Number: +44(0)1612475504
- Email: a.yau@mmu.ac.uk
Study Contact Backup
- Name: Gethin Evans, PhD
- Phone Number: +44(0)1612471208
- Email: gethin.evans@mmu.ac.uk
Study Locations
-
-
Greater Manchester
-
Manchester, Greater Manchester, United Kingdom, M1 5GD
- Recruiting
- Manchester Metropolitan University
-
Contact:
- Adora Yau, PhD
- Phone Number: +44(0)1612475504
- Email: a.yau@mmu.ac.uk
-
Contact:
- Gethin Evans, PhD
- Phone Number: +44(0)1612471208
- Email: gethin.evans@mmu.ac.uk
-
Principal Investigator:
- Adora Yau, PhD
-
Sub-Investigator:
- Gethin Evans, PhD
-
Sub-Investigator:
- Ria Weston, PhD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Fasted exercise
Exercise training in the fasted state
|
Four weeks of moderate intensity cycling exercise, three times a week without eating breakfast meal
|
Active Comparator: Fed exercise
Exercise training in the fed state
|
Four weeks of moderate intensity cycling exercise, three times a week, after eating breakfast meal
|
No Intervention: Control
No exercise training
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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)
|
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
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)
|
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
Time Frame: 4.5 hours
|
Total responses of clinical chemistry blood analytes (glucose, triglycerides, cholesterol)
|
4.5 hours
|
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)
|
4 weeks (pre and post intervention)
|
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
|
4 weeks (pre and post intervention)
|
Changes in concentration of sirtuin molecules
Time Frame: 4 weeks (pre and post intervention)
|
Serum concentrations of sirtuins
|
4 weeks (pre and post intervention)
|
Changes in sirtuin molecule gene expression
Time Frame: 4 weeks (pre and post intervention)
|
Adipose tissue gene expression of sirtuins
|
4 weeks (pre and post intervention)
|
Changes in sirtuin molecule tissue expression
Time Frame: 4 weeks (pre and post intervention)
|
Adipose tissue expression and cellular localisation of sirtuins
|
4 weeks (pre and post intervention)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Changes in cardiovascular and metabolic disease anthropometric risk factors
Time Frame: 4 weeks (pre and post intervention)
|
Waist circumference, hip circumference and waist:hip ratio
|
4 weeks (pre and post intervention)
|
Change in body composition
Time Frame: 4 weeks (pre and post intervention)
|
Body fat percentage measured using bioelectrical impedance analysis
|
4 weeks (pre and post intervention)
|
Change in body mass
Time Frame: 4 weeks (pre and post intervention)
|
Body mass in kilograms
|
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.
|
Carbohydrate and fat oxidation through indirect calorimetry
|
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
|
Heart rate during exercise in the experimental trial using telemetry
|
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
|
Rating of perceived exertion of exercise in the experimental trial using Borg scale
|
Every 5 min during 50 min cycle exercise
|
Change in physical activity levels
Time Frame: Daily for 4 weeks
|
Physical activity energy expenditure during the intervention period
|
Daily for 4 weeks
|
Change in physical activity duration
Time Frame: Daily for 4 weeks
|
Amount of time spent performing physical activity at different intensities (low, moderate, high) during the intervention period
|
Daily for 4 weeks
|
Change in energy intake
Time Frame: Daily for 4 weeks
|
Energy intake using weighed food diary record during the intervention period
|
Daily for 4 weeks
|
Change in dietary nutritional intake
Time Frame: Daily for 4 weeks
|
Macronutrient (carbohydrate, fat, protein) composition of food intake using weighed food diary record during the intervention period
|
Daily for 4 weeks
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Adora Yau, PhD, Manchester Metropolitan University
- Study Director: Gethin Evans, PhD, Manchester Metropolitan University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- FastExTrainESPEN2022
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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