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OpenTrials
Completed

NCT Number: NCT02258399

Exercise in the Fasted State, Glucose Metabolism and Energy Balance

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.

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Key information

Age range

18 year–49 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Department for Health, University of Bath

Bath, BA2 7AY, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Exercise

Behavioral

Moderate intensity exercise

Breakfast

Dietary Supplement

Breakfast consumption

Primary outcomes

  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 outcomes

  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).

Sponsors and collaborators

Lead sponsor

University of Bath

Other

Collaborators

  • University of Birmingham
  • University of Stirling

Registry information

Important dates

Study start
2015
Primary completion
2016
Study completion
2017
First posted
Oct 7, 2014
Registry last updated
Apr 2, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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