Role of Fasted Exercise on Improving Cardiometabolic Health

NCT05742373 | Recruiting

• 1 other identifier: FastExTrainESPEN2022
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Cardiovascular Diseases; Diabetes Mellitus, Type 2; Obesity

Keywords

Cardiovascular disease; Diabetes Mellitus; Obesity; Cardiometabolic health; Exercise; Fasted; Sirtuins

Outcome Measures

Primary Outcomes (8)

• 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

• 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

• 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

• 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)

• 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)

• Changes in concentration of sirtuin molecules

  Serum concentrations of sirtuins

  4 weeks (pre and post intervention)

• Changes in sirtuin molecule gene expression

  Adipose tissue gene expression of sirtuins

  4 weeks (pre and post intervention)

• Changes in sirtuin molecule tissue expression

  Adipose tissue expression and cellular localisation of sirtuins

  4 weeks (pre and post intervention)

Secondary Outcomes (10)

• Changes in cardiovascular and metabolic disease anthropometric risk factors

  4 weeks (pre and post intervention)

• Change in body composition

  4 weeks (pre and post intervention)

• Change in body mass

  4 weeks (pre and post intervention)

• 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.

• Heart rate response to exercise

  At rest before exercise then every 5 min during 50 min cycle exercise

Study Arms (3)

Fasted exercise

EXPERIMENTAL

Exercise training in the fasted state

Other: Exercise training in the fasted state

Fed exercise

ACTIVE COMPARATOR

Exercise training in the fed state

Other: Exercise training in the fed state

Control

NO INTERVENTION

No exercise training

Interventions

Exercise training in the fasted state OTHER

Four weeks of moderate intensity cycling exercise, three times a week without eating breakfast meal

Fasted exercise

Exercise training in the fed state OTHER

Four weeks of moderate intensity cycling exercise, three times a week, after eating breakfast meal

Fed exercise

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Manchester Metropolitan University: lead
• European Society for Clinical Nutrition and Metabolism: collaborator

Study Sites (1)

Manchester Metropolitan University

Manchester, Greater Manchester, M1 5GD, United Kingdom

RECRUITING

MeSH Terms

Conditions

Cardiovascular Diseases; Diabetes Mellitus, Type 2; Obesity; Diabetes Mellitus; Motor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Overweight; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Adora Yau, PhD

  Manchester Metropolitan University

  PRINCIPAL INVESTIGATOR

• Gethin Evans, PhD

  Manchester Metropolitan University

  STUDY DIRECTOR

Central Study Contacts

Adora Yau, PhD

CONTACT

+44(0)1612475504; a.yau@mmu.ac.uk

Gethin Evans, PhD

CONTACT

+44(0)1612471208; gethin.evans@mmu.ac.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Lecturer

Model Details: Randomised control

Study Record Dates

• First Submitted: January 27, 2023
• First Posted: February 24, 2023
• Study Start: March 1, 2023
• Primary Completion: April 1, 2025
• Study Completion: May 1, 2025
• Last Updated: March 7, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)