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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02258399
Other study ID # RE-FH1109
Secondary ID
Status Completed
Phase N/A
First received October 2, 2014
Last updated March 30, 2018
Start date May 2015
Est. completion date December 2017

Study information

Verified date March 2018
Source University of Bath
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 12
Est. completion date December 2017
Est. primary completion date June 2016
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 18 Years to 49 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Exercise
Moderate intensity exercise
Dietary Supplement:
Breakfast
Breakfast consumption

Locations

Country Name City State
United Kingdom Department for Health, University of Bath Bath

Sponsors (3)

Lead Sponsor Collaborator
University of Bath University of Birmingham, University of Stirling

Country where clinical trial is conducted

United Kingdom, 

References & Publications (2)

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. — View Citation

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. Review. — View Citation

Outcome

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