NCT02258399

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2015

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 2, 2014

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 7, 2014

Completed
7 months until next milestone

Study Start

First participant enrolled

May 1, 2015

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2016

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

April 2, 2018

Status Verified

March 1, 2018

Enrollment Period

1.1 years

First QC Date

October 2, 2014

Last Update Submit

March 30, 2018

Conditions

Energy BalanceBlood Glucose

Outcome Measures

Primary Outcomes (2)

  • Exogenous glucose appearance rate

    Exogenous glucose appearance rates following an oral glucose tolerance test (total appearance over 120 minutes).

    120 minutes

  • Energy balance

    Energy balance (intake minus expenditure) over 24 h from the beginning of the trial

    24 hours

Secondary Outcomes (5)

  • Endogenous glucose appearance rates

    120 minutes

  • Glucose clearance rates

    120 minutes

  • Energy intake

    24 h

  • Energy expenditure

    24 h

  • Exogenous glucose appearance rates

    120 minutes

Study Arms (3)

Breakfast Rest

ACTIVE COMPARATOR
Dietary Supplement: Breakfast

Breakfast Exercise

ACTIVE COMPARATOR
Behavioral: ExerciseDietary Supplement: Breakfast

Fasted Exercise

EXPERIMENTAL
Behavioral: Exercise

Interventions

ExerciseBEHAVIORAL

Moderate intensity exercise

Breakfast ExerciseFasted Exercise
BreakfastDIETARY_SUPPLEMENT

Breakfast consumption

Breakfast ExerciseBreakfast Rest

Eligibility Criteria

Age18 Years - 49 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department for Health, University of Bath

Bath, BA2 7AY, United Kingdom

Location

Related Publications (4)

  • 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.

    PMID: 24986552BACKGROUND

  • 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.

    PMID: 23340006BACKGROUND

  • 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.

    PMID: 33512717DERIVED

  • 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.

    PMID: 31321428DERIVED

MeSH Terms

Interventions

ExerciseBreakfast

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological PhenomenaMealsFoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer

Study Record Dates

First Submitted

October 2, 2014

First Posted

October 7, 2014

Study Start

May 1, 2015

Primary Completion

June 1, 2016

Study Completion

December 1, 2017

Last Updated

April 2, 2018

Record last verified: 2018-03

Locations

GB(1)