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Exercise in the Fasted State, Glucose Metabolism and Energy Balance

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ClinicalTrials.gov Identifier: NCT02258399
Recruitment Status : Completed
First Posted : October 7, 2014
Last Update Posted : April 2, 2018
Sponsor:
Collaborators:
University of Stirling
University of Birmingham
Information provided by (Responsible Party):
Javier Gonzalez, University of Bath

Brief Summary:
The ability to control our blood glucose (sugar) concentrations after a meal is a strong predictor of the risk of disease. Our bodies respond to glucose ingestion by reducing the amount of glucose from the liver entering the bloodstream. At the same time muscle increases the amount of glucose it take up from the bloodstream. This ensures that our blood glucose levels do not get too high. The investigators want to understand what happens to these processes following exercise after breakfast and after an overnight fast. In addition, the investigators also want to understand whether exercising with or without breakfast influences our appetite, food intake and activity levels later in the day.

Condition or disease Intervention/treatment Phase
Energy Balance Blood Glucose Behavioral: Exercise Dietary Supplement: Breakfast Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Study Start Date : May 2015
Actual Primary Completion Date : June 2016
Actual Study Completion Date : December 2017

Arm Intervention/treatment
Active Comparator: Breakfast Rest Dietary Supplement: Breakfast
Breakfast consumption

Active Comparator: Breakfast Exercise Behavioral: Exercise
Moderate intensity exercise

Dietary Supplement: Breakfast
Breakfast consumption

Experimental: Fasted Exercise Behavioral: Exercise
Moderate intensity exercise




Primary Outcome Measures :
  1. Exogenous glucose appearance rate [ Time Frame: 120 minutes ]
    Exogenous glucose appearance rates following an oral glucose tolerance test (total appearance over 120 minutes).

  2. Energy balance [ Time Frame: 24 hours ]
    Energy balance (intake minus expenditure) over 24 h from the beginning of the trial


Secondary Outcome Measures :
  1. Endogenous glucose appearance rates [ Time Frame: 120 minutes ]
    Endogenous glucose appearance rates following an oral glucose tolerance test (total appearance over 120 minutes).

  2. Glucose clearance rates [ Time Frame: 120 minutes ]
    Glucose clearance rates following an oral glucose tolerance test (total clearance over 120 minutes).

  3. Energy intake [ Time Frame: 24 h ]
    Weighted energy intake over 24 hours from the beginning of the trial.

  4. Energy expenditure [ Time Frame: 24 h ]
    Energy expenditure, derived from indirect calorimetry, acccelerometry and heart rate monitoring.

  5. Exogenous glucose appearance rates [ Time Frame: 120 minutes ]
    Exogenous glucose appearance rates following an oral glucose tolerance test (total appearance over 120 minutes).



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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:

  • Males.
  • Aged 18-49.
  • Individuals free from known cardiovascular, metabolic or joint disease as determined by standard health questionnaire.
  • Habitual regularly participating in exercise (minimum of 3 sessions per week on average)
  • Non-smoker

Exclusion Criteria:

  • Known or suspected food intolerances, allergies or hypersensitivity.
  • Any bleeding disorder or taking medication which impacts blood coagulation.
  • Known tendency towards keloid scarring.
  • Known sensitivity or allergy to any local anaesthetic medicines.
  • Any reported use of substances which may pose undue personal risk to participants or introduce bias into the experiment.
  • Any other condition or behaviour deemed either to pose undue personal risk to participants 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): NCT02258399


Locations
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United Kingdom
Department for Health, University of Bath
Bath, United Kingdom, BA2 7AY
Sponsors and Collaborators
University of Bath
University of Stirling
University of Birmingham
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Javier Gonzalez, Lecturer, University of Bath
ClinicalTrials.gov Identifier: NCT02258399    
Other Study ID Numbers: RE-FH1109
First Posted: October 7, 2014    Key Record Dates
Last Update Posted: April 2, 2018
Last Verified: March 2018