Clinical trial NCT02258399: Exercise in the Fasted State, Glucose Metabolism and Energy Balance
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Energy Balance
Blood Glucose
Lead sponsor: University of Bath
Sponsor class: OTHER
Collaborators: name: University of Stirling
name: University of Birmingham
First posted: 2014-10-07
Enrollment: 12
Sex: MALE
Minimum age (years): 18
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Exogenous glucose appearance rate
timeFrame: 120 minutes
measure: Energy balance
timeFrame: 24 hours
Secondary outcomes:
measure: Endogenous glucose appearance rates
timeFrame: 120 minutes
measure: Glucose clearance rates
timeFrame: 120 minutes
measure: Energy intake
timeFrame: 24 h
measure: Energy expenditure
timeFrame: 24 h
measure: Exogenous glucose appearance rates
timeFrame: 120 minutes
Other outcomes:
Locations:
city: Bath
country: United Kingdom
facility: Department for Health, University of Bath
Study officials:
References:
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.
citation: 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.
citation: 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.
citation: 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.