Role of Fasted Exercise on Improving Cardiometabolic Health

Obesity Clinical Trial

Official title:

Investigating the Role of Fasted Exercise on Improving Cardiometabolic Health; a Potential Mediatory Role of Sirtuins

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05742373
• Other study ID #: FastExTrainESPEN2022
• Status: Recruiting
• Phase: N/A
• Start date: March 1, 2023
• Est. completion date: May 2025

Study information

• Verified date: March 2024
• Source: Manchester Metropolitan University
• Contact: Adora Yau, PhD
• Phone: +44(0)1612475504
• Email: a.yau[@]mmu.ac.uk
• Is FDA regulated: No
• Study type: Interventional

Clinical 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). 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: May 2025
• Est. primary completion date: April 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 40 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Obesity

Intervention

Other:
• Exercise training in the fasted state
Four weeks of moderate intensity cycling exercise, three times a week without eating breakfast meal
• Exercise training in the fed state
Four weeks of moderate intensity cycling exercise, three times a week, after eating breakfast meal

Locations

Country	Name	City	State
United Kingdom	Manchester Metropolitan University	Manchester	Greater Manchester

Sponsors (2)

Lead Sponsor	Collaborator
Manchester Metropolitan University	European Society for Clinical Nutrition and Metabolism

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in circulating concentrations of key metabolic markers following a high fat lunch meal	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
Primary	Changes in circulating concentrations of key metabolic markers during the experimental trial day	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
Primary	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)	4.5 hours
Primary	Changes in cardiovascular and metabolic disease biochemistry risk factors	Fasted serum concentrations of clinical chemistry blood analytes (glucose, blood lipids, inflammatory markers)	4 weeks (pre and post intervention)
Primary	Changes in cardiovascular disease physiological risk factors	Systolic and diastolic blood pressure and calculation of mean arterial pressure using systolic and diastolic values	4 weeks (pre and post intervention)
Primary	Changes in concentration of sirtuin molecules	Serum concentrations of sirtuins	4 weeks (pre and post intervention)
Primary	Changes in sirtuin molecule gene expression	Adipose tissue gene expression of sirtuins	4 weeks (pre and post intervention)
Primary	Changes in sirtuin molecule tissue expression	Adipose tissue expression and cellular localisation of sirtuins	4 weeks (pre and post intervention)
Secondary	Changes in cardiovascular and metabolic disease anthropometric risk factors	Waist circumference, hip circumference and waist:hip ratio	4 weeks (pre and post intervention)
Secondary	Change in body composition	Body fat percentage measured using bioelectrical impedance analysis	4 weeks (pre and post intervention)
Secondary	Change in body mass	Body mass in kilograms	4 weeks (pre and post intervention)
Secondary	Change in substrate oxidation during the experimental trial day	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.
Secondary	Heart rate response to exercise	Heart rate during exercise in the experimental trial using telemetry	At rest before exercise then every 5 min during 50 min cycle exercise
Secondary	Perceived exertion	Rating of perceived exertion of exercise in the experimental trial using Borg scale	Every 5 min during 50 min cycle exercise
Secondary	Change in physical activity levels	Physical activity energy expenditure during the intervention period	Daily for 4 weeks
Secondary	Change in physical activity duration	Amount of time spent performing physical activity at different intensities (low, moderate, high) during the intervention period	Daily for 4 weeks
Secondary	Change in energy intake	Energy intake using weighed food diary record during the intervention period	Daily for 4 weeks
Secondary	Change in dietary nutritional intake	Macronutrient (carbohydrate, fat, protein) composition of food intake using weighed food diary record during the intervention period	Daily for 4 weeks