Exercise in the Fasted State, Glucose Metabolism and Energy Balance

Blood Glucose Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02258399
• Other study ID #: RE-FH1109
• 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
• 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.

Related Conditions & MeSH terms

• Blood Glucose
• Energy Balance

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