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Training in the Fasted State, Glucose Metabolism and Energy Balance

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02744183
Recruitment Status : Completed
First Posted : April 20, 2016
Last Update Posted : November 7, 2019
Sponsor:
Information provided by (Responsible Party):
Javier Gonzalez, University of Bath

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

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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 : September 2016
Actual Primary Completion Date : August 2018
Actual Study Completion Date : September 2019

Resource links provided by the National Library of Medicine


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




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)



Information from the National Library of Medicine

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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02744183


Locations
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United Kingdom
Department for Health, University of Bath
Bath, United Kingdom, BA2 7AY
Sponsors and Collaborators
University of Bath
Investigators
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Principal Investigator: Javier Gonzalez, PhD University of Bath
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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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    Key Record Dates
Last Update Posted: November 7, 2019
Last Verified: November 2019
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:
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Metabolic Diseases
Glucose Metabolism Disorders
Benzocaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents