- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02258399
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
Conditions
Intervention / Treatment
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.
Sponsor
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.
General Publications
- Allaf M, Elghazaly H, Mohamed OG, Fareen MFK, Zaman S, Salmasi AM, Tsilidis K, Dehghan A. Intermittent fasting for the prevention of cardiovascular disease. Cochrane Database Syst Rev. 2021 Jan 29;1(1):CD013496. doi: 10.1002/14651858.CD013496.pub2.
- Gonzalez JT, Veasey RC, Rumbold PL, Stevenson EJ. Breakfast and exercise contingently affect postprandial metabolism and energy balance in physically active males. Br J Nutr. 2013 Aug;110(4):721-32. doi: 10.1017/S0007114512005582. Epub 2013 Jan 29.
- Gonzalez JT. Paradoxical second-meal phenomenon in the acute postexercise period. Nutrition. 2014 Sep;30(9):961-7. doi: 10.1016/j.nut.2013.12.001. Epub 2013 Dec 14.
- Edinburgh RM, Hengist A, Smith HA, Travers RL, Betts JA, Thompson D, Walhin JP, Wallis GA, Hamilton DL, Stevenson EJ, Tipton KD, Gonzalez JT. Skipping Breakfast Before Exercise Creates a More Negative 24-hour Energy Balance: A Randomized Controlled Trial in Healthy Physically Active Young Men. J Nutr. 2019 Aug 1;149(8):1326-1334. doi: 10.1093/jn/nxz018.
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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