Cardiovascular Diseases, Diabetes Mellitus, Type 2, Obesity
Conditions
Keywords
Cardiovascular disease, Diabetes Mellitus, Obesity, Cardiometabolic health, Exercise, Fasted, Sirtuins
Brief 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). 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: 1. The effect of a single bout of fasted exercise on acute metabolic responses following a high fat meal. 2. The effect of four weeks of fasted exercise training on cardiovascular and metabolic disease risk factors. 3. 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.
Interventions
OTHERExercise training in the fasted state
Four weeks of moderate intensity cycling exercise, three times a week without eating breakfast meal
OTHERExercise training in the fed state
Four weeks of moderate intensity cycling exercise, three times a week, after eating breakfast meal
Sponsors
European Society for Clinical Nutrition and Metabolism
Manchester Metropolitan University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE
Intervention model description
Randomised control
Eligibility
Sex/Gender
ALL
Age
18 Years to 40 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes in circulating concentrations of key metabolic markers following a high fat lunch meal | 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 | 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 | 4.5 hours | Total responses of clinical chemistry blood analytes (glucose, triglycerides, cholesterol) |
| Changes in cardiovascular and metabolic disease biochemistry risk factors | 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 | 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 | 4 weeks (pre and post intervention) | Serum concentrations of sirtuins |
| Changes in sirtuin molecule gene expression | 4 weeks (pre and post intervention) | Adipose tissue gene expression of sirtuins |
| Changes in sirtuin molecule tissue expression | 4 weeks (pre and post intervention) | Adipose tissue expression and cellular localisation of sirtuins |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in energy intake | Daily for 4 weeks | Energy intake using weighed food diary record during the intervention period |
| Changes in cardiovascular and metabolic disease anthropometric risk factors | 4 weeks (pre and post intervention) | Waist circumference, hip circumference and waist:hip ratio |
| Change in dietary nutritional intake | Daily for 4 weeks | Macronutrient (carbohydrate, fat, protein) composition of food intake using weighed food diary record during the intervention period |
| Change in body composition | 4 weeks (pre and post intervention) | Body fat percentage measured using bioelectrical impedance analysis |
| Change in body mass | 4 weeks (pre and post intervention) | Body mass in kilograms |
| Change in substrate oxidation during the experimental trial day | 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 |
| Heart rate response to exercise | At rest before exercise then every 5 min during 50 min cycle exercise | Heart rate during exercise in the experimental trial using telemetry |
| Perceived exertion | Every 5 min during 50 min cycle exercise | Rating of perceived exertion of exercise in the experimental trial using Borg scale |
| Change in physical activity levels | Daily for 4 weeks | Physical activity energy expenditure during the intervention period |
| Change in physical activity duration | Daily for 4 weeks | Amount of time spent performing physical activity at different intensities (low, moderate, high) during the intervention period |
Countries
United Kingdom
Contacts
Primary ContactAdora Yau, PhD
Backup ContactGethin Evans, PhD
Outcome results
None listed