NCT02744183

Brief Summary

In healthy individuals, the body responds to glucose (sugar) ingestion by reducing the amount released from the liver. At the same time, skeletal muscles increase the rate at which they remove the glucose from the bloodstream, via the actions of the hormone insulin. This ensures that blood glucose levels remain in a controlled range. However, in developed countries, diseases such as metabolic syndrome and type 2 diabetes are becoming prevalent, due to dietary modifications and a reduction in physical activity. As one of the prominent barriers to regular physical activity is a lack of time, finding ways to maximize the health benefits of exercise is a priority for researchers. The investigators want to understand potential differences in the effects of six weeks of aerobic training, with the exercise performed either after breakfast or after a prolonged fast. Specifically, this research aims to investigate whether there is a difference in the change in processes implicated in glucose regulation and secondly, in subsequent eating and physical activity behaviors. By investigating these changes this work will explore how exercise and nutrition can be optimized to benefit health and weight loss.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2016

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

April 11, 2016

Completed
9 days until next milestone

First Posted

Study publicly available on registry

April 20, 2016

Completed
5 months until next milestone

Study Start

First participant enrolled

October 1, 2016

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2018

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2019

Completed
Last Updated

November 25, 2022

Status Verified

November 1, 2022

Enrollment Period

1.8 years

First QC Date

April 11, 2016

Last Update Submit

November 23, 2022

Conditions

Keywords

ExerciseFastedGlucoseEnergy Balance

Outcome Measures

Primary Outcomes (2)

  • Postprandial plasma glucose concentrations

    Response to oral glucose tolerance test (area under the curve)

    120 mins - (change after 6 weeks)

  • Postprandial insulin concentrations

    Response to oral glucose tolerance test (area under the curve)

    120 mins - (change after 6 weeks)

Secondary Outcomes (29)

  • Oral Glucose Insulin Sensitivity Index

    120 mins - (change after 6 weeks)

  • Cardiorespiratory fitness (VO2max)

    Change after 6 weeks

  • Habitual energy intake

    Change after 6 weeks

  • Habitual energy expenditure

    Change after 6 weeks

  • Body mass (kg)

    Change after 6 weeks

  • +24 more secondary outcomes

Study Arms (3)

Control Group

ACTIVE COMPARATOR

Maintain habitual habits

Behavioral: Maintain habitual habits

Fed Exercise

ACTIVE COMPARATOR

6 weeks of moderate intensity exercise with breakfast consumption

Behavioral: ExerciseBehavioral: Breakfast

Fasted Exercise

EXPERIMENTAL

6 weeks of moderate intensity exercise with breakfast omission

Behavioral: Exercise

Interventions

ExerciseBEHAVIORAL

Moderate intensity exercise

Fasted ExerciseFed Exercise
BreakfastBEHAVIORAL

Breakfast consumption

Fed Exercise

Normal physical activity and dietary behaviors maintained

Control Group

Eligibility Criteria

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

You may qualify if:

  • Male
  • Aged 18-49
  • Body mass index (BMI) \> 25 kg/m2
  • Weight stable for \> 6 months
  • Not currently engaging in any form of structured exercise
  • Be able and willing to give informed oral and written consent
  • Complete and meet the defined criteria of pre-study questionnaires and screen

You may not qualify if:

  • Have a history of metabolic, cardio-pulmonary or musculoskeletal disease
  • Have plans to change diet and/or physical activity outside of the intervention
  • Taking regular medication or food supplements from which it is not possible to refrain and which are known to influence any of the outcome measures.
  • Failure to refrain from alcohol and/or caffeine containing drinks or strenuous exercise one day before or during the trial days
  • Smokers
  • Any reported condition or behavior deemed to pose a risk to the participant 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 (3)

  • 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
  • Van Proeyen K, Szlufcik K, Nielens H, Pelgrim K, Deldicque L, Hesselink M, Van Veldhoven PP, Hespel P. Training in the fasted state improves glucose tolerance during fat-rich diet. J Physiol. 2010 Nov 1;588(Pt 21):4289-302. doi: 10.1113/jphysiol.2010.196493.

    PMID: 20837645BACKGROUND
  • Edinburgh RM, Bradley HE, Abdullah NF, Robinson SL, Chrzanowski-Smith OJ, Walhin JP, Joanisse S, Manolopoulos KN, Philp A, Hengist A, Chabowski A, Brodsky FM, Koumanov F, Betts JA, Thompson D, Wallis GA, Gonzalez JT. Lipid Metabolism Links Nutrient-Exercise Timing to Insulin Sensitivity in Men Classified as Overweight or Obese. J Clin Endocrinol Metab. 2020 Mar 1;105(3):660-76. doi: 10.1210/clinem/dgz104.

MeSH Terms

Conditions

Glucose Metabolism DisordersMotor Activity

Interventions

ExerciseBreakfast

Condition Hierarchy (Ancestors)

Metabolic DiseasesNutritional and Metabolic DiseasesBehavior

Intervention Hierarchy (Ancestors)

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

Study Officials

  • Javier Gonzalez, PhD

    University of Bath

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr Javier Gonzalez

Study Record Dates

First Submitted

April 11, 2016

First Posted

April 20, 2016

Study Start

October 1, 2016

Primary Completion

August 1, 2018

Study Completion

September 1, 2019

Last Updated

November 25, 2022

Record last verified: 2022-11

Data Sharing

IPD Sharing
Will not share

Locations