Exercise in the Fasted State, Glucose Metabolism and Energy Balance

March 30, 2018 updated by: Javier Gonzalez, University of Bath
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.

Study Overview

Status

Completed

Study Type

Interventional

Enrollment (Actual)

12

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Bath, United Kingdom, BA2 7AY
        • Department for Health, University of Bath

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 49 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Breakfast Rest
Breakfast consumption
Active Comparator: Breakfast Exercise
Moderate intensity exercise
Breakfast consumption
Experimental: Fasted Exercise
Moderate intensity exercise

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Exogenous glucose appearance rate
Time Frame: 120 minutes
Exogenous glucose appearance rates following an oral glucose tolerance test (total appearance over 120 minutes).
120 minutes
Energy balance
Time Frame: 24 hours
Energy balance (intake minus expenditure) over 24 h from the beginning of the trial
24 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Endogenous glucose appearance rates
Time Frame: 120 minutes
Endogenous glucose appearance rates following an oral glucose tolerance test (total appearance over 120 minutes).
120 minutes
Glucose clearance rates
Time Frame: 120 minutes
Glucose clearance rates following an oral glucose tolerance test (total clearance over 120 minutes).
120 minutes
Energy intake
Time Frame: 24 h
Weighted energy intake over 24 hours from the beginning of the trial.
24 h
Energy expenditure
Time Frame: 24 h
Energy expenditure, derived from indirect calorimetry, acccelerometry and heart rate monitoring.
24 h
Exogenous glucose appearance rates
Time Frame: 120 minutes
Exogenous glucose appearance rates following an oral glucose tolerance test (total appearance over 120 minutes).
120 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2015

Primary Completion (Actual)

June 1, 2016

Study Completion (Actual)

December 1, 2017

Study Registration Dates

First Submitted

October 2, 2014

First Submitted That Met QC Criteria

October 6, 2014

First Posted (Estimate)

October 7, 2014

Study Record Updates

Last Update Posted (Actual)

April 2, 2018

Last Update Submitted That Met QC Criteria

March 30, 2018

Last Verified

March 1, 2018

More Information

Terms related to this study

Other Study ID Numbers

  • RE-FH1109

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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