Training in the Fasted State, Glucose Metabolism and Energy Balance

• ClinicalTrials.gov Identifier: NCT02744183
• Recruitment Status: Completed
• First Posted: April 20, 2016
• Last Update Posted: November 25, 2022
• Sponsor: University of Bath
• Information provided by (Responsible Party): Javier Gonzalez, University of Bath

Study Description

Brief Summary:

In healthy individuals, the body responds to glucose (sugar) ingestion by reducing the amount released from the liver. At the same time, skeletal muscles increase the rate at which they remove the glucose from the bloodstream, via the actions of the hormone insulin. This ensures that blood glucose levels remain in a controlled range. However, in developed countries, diseases such as metabolic syndrome and type 2 diabetes are becoming prevalent, due to dietary modifications and a reduction in physical activity. As one of the prominent barriers to regular physical activity is a lack of time, finding ways to maximize the health benefits of exercise is a priority for researchers.

The investigators want to understand potential differences in the effects of six weeks of aerobic training, with the exercise performed either after breakfast or after a prolonged fast. Specifically, this research aims to investigate whether there is a difference in the change in processes implicated in glucose regulation and secondly, in subsequent eating and physical activity behaviors. By investigating these changes this work will explore how exercise and nutrition can be optimized to benefit health and weight loss.

Condition or disease	Intervention/treatment	Phase
Glucose Metabolism Disorders	Behavioral: Exercise; Behavioral: Breakfast; Behavioral: Maintain habitual habits	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 30 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Basic Science
• Official Title: Training in the Fasted State, Glucose Metabolism and Energy Balance
• Actual Study Start Date: October 2016
• Actual Primary Completion Date: August 2018
• Actual Study Completion Date: September 2019

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: Control Group; Maintain habitual habits	Behavioral: Maintain habitual habits; Normal physical activity and dietary behaviors maintained
Active Comparator: Fed Exercise; 6 weeks of moderate intensity exercise with breakfast consumption	Behavioral: Exercise; Moderate intensity exercise; Behavioral: Breakfast; Breakfast consumption
Experimental: Fasted Exercise; 6 weeks of moderate intensity exercise with breakfast omission	Behavioral: Exercise; Moderate intensity exercise

Outcome Measures

Primary Outcome Measures :

1. Postprandial plasma glucose concentrations [ Time Frame: 120 mins - (change after 6 weeks) ]
   Response to oral glucose tolerance test (area under the curve)
2. Postprandial insulin concentrations [ Time Frame: 120 mins - (change after 6 weeks) ]
   Response to oral glucose tolerance test (area under the curve)

Secondary Outcome Measures :

1. Oral Glucose Insulin Sensitivity Index [ Time Frame: 120 mins - (change after 6 weeks) ]
   Response to oral glucose tolerance test
2. Cardiorespiratory fitness (VO2max) [ Time Frame: Change after 6 weeks ]
3. Habitual energy intake [ Time Frame: Change after 6 weeks ]
   Assessed via a food diary, completed at baseline and during the last week of the intervention
4. Habitual energy expenditure [ Time Frame: Change after 6 weeks ]
   Assessed via an Actiheart monitor, completed at baseline and during the last week of the intervention
5. Body mass (kg) [ Time Frame: Change after 6 weeks ]
6. Waist and hip circumference (cm) [ Time Frame: Change after 6 weeks ]
7. Maximal rate of whole-body lipid oxidation (g/min) [ Time Frame: Change after 6 weeks ]
   During an incremental exercise test
8. Fasting plasma glucose concentration [ Time Frame: Basal Concentrations - (change after 6 weeks) ]
   Fasting plasma glucose concentration (mmol/L)
9. Fasting plasma insulin concentration [ Time Frame: Basal Concentrations - (change after 6 weeks) ]
   Fasting plasma insulin concentration (pmol/L)
10. Postprandial non-esterified fatty acid concentrations [ Time Frame: 120 mins - (change after 6 weeks) ]
    Response to oral glucose tolerance test (total and incremental area under the curve)
11. Fasting plasma triglyceride concentrations [ Time Frame: Basal Concentrations - (change after 6 weeks) ]
    Fasting plasma triglyceride concentrations (mmol/L)
12. Fasting plasma total cholesterol concentrations [ Time Frame: Basal Concentrations - (change after 6 weeks) ]
    Fasting plasma total cholesterol concentrations (mmol/L)
13. Fasting plasma HDL cholesterol concentrations [ Time Frame: Basal Concentrations - (change after 6 weeks) ]
    Fasting plasma HDL cholesterol concentrations (mmol/L)
14. Fasting plasma LDL cholesterol concentrations [ Time Frame: Basal Concentrations - (change after 6 weeks) ]
    Fasting plasma LDL cholesterol concentrations (mmol/L)
15. Fasting plasma non-esterified fatty acid concentrations [ Time Frame: Basal Concentrations - (change after 6 weeks) ]
    Fasting plasma non-esterified fatty acid concentrations (mmol/L)
16. Waist to hip ratio [ Time Frame: Change after 6 weeks ]
    Waist circumference (cm) divided by hip circumference (cm)
17. Citrate Synthase Activity (mitochondrial citrate synthase activity in each muscle sample in an immunocapture based manner) [ Time Frame: Change after 6 weeks ]
    Skeletal muscle (vastus lateralis). Citrate Synthase Activity Assay Kit.
18. Protein content of mitochondrial respiratory chain proteins [ Time Frame: Change after 6 weeks. For each participant the protein content will be presented as the fold change from baseline (arbitrary units). ]
    Skeletal muscle (vastus lateralis). Complex I, Complex II, Complex III, Complex IV.
19. Protein content of carnitine palmitoyltransferase I (CPT-1) [ Time Frame: Change after 6 weeks. For each participant the protein content will be presented as the fold change from baseline (arbitrary units) ]
    Skeletal muscle (vastus lateralis)
20. Protein content of cluster of differentiation 36 (CD36) [ Time Frame: Change after 6 weeks. For each participant the protein content will be presented as the fold change from baseline (arbitrary units) ]
    Skeletal muscle (vastus lateralis)
21. Protein content (total and phosphorylated form) of AMP-activated protein kinase (AMPK) [ Time Frame: Change after 6 weeks. For each participant the protein content will be presented as the fold change from baseline (arbitrary units) ]
    Skeletal muscle (vastus lateralis)
22. Resting metabolic rate (RMR) [ Time Frame: Change after 6 weeks ]
    Assessed via indirect calirometry
23. Energy balance [ Time Frame: Change after 6 weeks (during week 6 of intervention versus baseline monitoring) ]
    Total energy expenditure minus total energy intake
24. Whole-body lipid utilisation during exercise [ Time Frame: Change throughout complete training period (weeks 1 through to 6). Samples will be collected during every training session (three times weekly for six weeks) ]
    Assessed via indirect calirometry during every exercise session (at ten minute intervals)
25. Whole-body carbohydrate utilisation during exercise [ Time Frame: Change throughout complete training period (weeks 1 through to 6). Samples will be collected during every training session (three times weekly for six weeks) ]
    Assessed via indirect calirometry during every exercise session (at ten minute intervals)
26. Homeostasis Model Assessment (HOMA2-IR) [ Time Frame: Change after 6 weeks ]
    The Homeostasis Model Assessment (HOMA) estimate of steady state beta cell function (%B) and insulin sensitivity (%S). Derived from fasting plasma glucose and fasting plasma insulin concentrations.
27. Fasting plasma glycerol concentrations [ Time Frame: Basal Concentrations - (change after 6 weeks) ]
    Fasting plasma glycerol concentrations (mmol/L)
28. Postprandial plasma glycerol concentrations [ Time Frame: Change after 6 weeks ]
    Response to oral glucose tolerance test (total and incremental area under the curve)
29. Adipose Tissue Insulin Resistance Index (Adipo-IR) [ Time Frame: Change after 6 weeks ]
    Response to oral glucose tolerance test (total and incremental area under the curve)

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 49 Years (Adult)
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: Yes

Criteria

Inclusion Criteria:

• Male
• Aged 18-49
• Body mass index (BMI) > 25 kg/m2
• Weight stable for > 6 months
• Not currently engaging in any form of structured exercise
• Be able and willing to give informed oral and written consent
• Complete and meet the defined criteria of pre-study questionnaires and screen

Exclusion Criteria:

• Have a history of metabolic, cardio-pulmonary or musculoskeletal disease
• Have plans to change diet and/or physical activity outside of the intervention
• Taking regular medication or food supplements from which it is not possible to refrain and which are known to influence any of the outcome measures.
• Failure to refrain from alcohol and/or caffeine containing drinks or strenuous exercise one day before or during the trial days
• Smokers
• Any reported condition or behavior deemed to pose a risk to the participant or introduce bias into the experiment

Contacts and Locations

Locations

United Kingdom

Department for Health, University of Bath

Bath, United Kingdom, BA2 7AY

Sponsors and Collaborators

University of Bath

Investigators

• Principal Investigator: Javier Gonzalez, PhD; University of Bath

More Information

Publications:

Gonzalez JT, Veasey RC, Rumbold PL, Stevenson EJ. Breakfast and exercise contingently affect postprandial metabolism and energy balance in physically active males. Br J Nutr. 2013 Aug;110(4):721-32. doi: 10.1017/S0007114512005582. Epub 2013 Jan 29.

Van Proeyen K, Szlufcik K, Nielens H, Pelgrim K, Deldicque L, Hesselink M, Van Veldhoven PP, Hespel P. Training in the fasted state improves glucose tolerance during fat-rich diet. J Physiol. 2010 Nov 1;588(Pt 21):4289-302. doi: 10.1113/jphysiol.2010.196493.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Edinburgh RM, Bradley HE, Abdullah NF, Robinson SL, Chrzanowski-Smith OJ, Walhin JP, Joanisse S, Manolopoulos KN, Philp A, Hengist A, Chabowski A, Brodsky FM, Koumanov F, Betts JA, Thompson D, Wallis GA, Gonzalez JT. Lipid Metabolism Links Nutrient-Exercise Timing to Insulin Sensitivity in Men Classified as Overweight or Obese. J Clin Endocrinol Metab. 2020 Mar 1;105(3):660-76. doi: 10.1210/clinem/dgz104.

• Responsible Party: Javier Gonzalez, Dr Javier Gonzalez, University of Bath
• ClinicalTrials.gov Identifier: NCT02744183
• Other Study ID Numbers: EP 15/16129
• First Posted: April 20, 2016
• Last Update Posted: November 25, 2022
• Last Verified: November 2022

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

Keywords provided by Javier Gonzalez, University of Bath:

Exercise; Fasted; Glucose; Energy Balance

Additional relevant MeSH terms:

Metabolic Diseases; Glucose Metabolism Disorders; Benzocaine; Anesthetics, Local; Anesthetics; Central Nervous System Depressants; Physiological Effects of Drugs; Sensory System Agents; Peripheral Nervous System Agents