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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

Tracking Information
First Submitted Date  ICMJE October 2, 2014
First Posted Date  ICMJE October 7, 2014
Last Update Posted Date April 2, 2018
Study Start Date  ICMJE May 2015
Actual Primary Completion Date June 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 6, 2014)
  • Exogenous glucose appearance rate [ Time Frame: 120 minutes ]
    Exogenous glucose appearance rates following an oral glucose tolerance test (total appearance over 120 minutes).
  • Energy balance [ Time Frame: 24 hours ]
    Energy balance (intake minus expenditure) over 24 h from the beginning of the trial
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 27, 2015)
  • Endogenous glucose appearance rates [ Time Frame: 120 minutes ]
    Endogenous glucose appearance rates following an oral glucose tolerance test (total appearance over 120 minutes).
  • Glucose clearance rates [ Time Frame: 120 minutes ]
    Glucose clearance rates following an oral glucose tolerance test (total clearance over 120 minutes).
  • Energy intake [ Time Frame: 24 h ]
    Weighted energy intake over 24 hours from the beginning of the trial.
  • Energy expenditure [ Time Frame: 24 h ]
    Energy expenditure, derived from indirect calorimetry, acccelerometry and heart rate monitoring.
  • Exogenous glucose appearance rates [ Time Frame: 120 minutes ]
    Exogenous glucose appearance rates following an oral glucose tolerance test (total appearance over 120 minutes).
Original Secondary Outcome Measures  ICMJE
 (submitted: October 6, 2014)
  • Endogenous glucose appearance rates [ Time Frame: 120 minutes ]
    Endogenous glucose appearance rates following an oral glucose tolerance test (total appearance over 120 minutes).
  • Glucose clearance rates [ Time Frame: 120 minutes ]
    Endogenous glucose appearance rates following an oral glucose tolerance test (total appearance over 120 minutes).
  • Energy intake [ Time Frame: 24 h ]
    Weighted energy intake over 24 hours from the beginning of the trial.
  • Energy expenditure [ Time Frame: 24 h ]
    Energy expenditure, derived from indirect calorimetry, acccelerometry and heart rate monitoring.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Exercise in the Fasted State, Glucose Metabolism and Energy Balance
Official Title  ICMJE Not Provided
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Condition  ICMJE
  • Energy Balance
  • Blood Glucose
Intervention  ICMJE
  • Behavioral: Exercise
    Moderate intensity exercise
  • Dietary Supplement: Breakfast
    Breakfast consumption
Study Arms  ICMJE
  • Active Comparator: Breakfast Rest
    Intervention: Dietary Supplement: Breakfast
  • Active Comparator: Breakfast Exercise
    Interventions:
    • Behavioral: Exercise
    • Dietary Supplement: Breakfast
  • Experimental: Fasted Exercise
    Intervention: Behavioral: Exercise
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 6, 2014)
12
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 2017
Actual Primary Completion Date June 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 18 Years to 49 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02258399
Other Study ID Numbers  ICMJE RE-FH1109
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Javier Gonzalez, University of Bath
Original Responsible Party Same as current
Current Study Sponsor  ICMJE University of Bath
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE
  • University of Stirling
  • University of Birmingham
Investigators  ICMJE Not Provided
PRS Account University of Bath
Verification Date March 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP