Training in the Fasted State, Glucose Metabolism and Energy Balance
1 other identifier
interventional
30
1 country
1
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
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Oct 2016
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 11, 2016
CompletedFirst Posted
Study publicly available on registry
April 20, 2016
CompletedStudy Start
First participant enrolled
October 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2019
CompletedNovember 25, 2022
November 1, 2022
1.8 years
April 11, 2016
November 23, 2022
Conditions
Keywords
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 COMPARATORMaintain habitual habits
Fed Exercise
ACTIVE COMPARATOR6 weeks of moderate intensity exercise with breakfast consumption
Fasted Exercise
EXPERIMENTAL6 weeks of moderate intensity exercise with breakfast omission
Interventions
Normal physical activity and dietary behaviors maintained
Eligibility Criteria
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
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: 23340006BACKGROUNDVan 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: 20837645BACKGROUNDEdinburgh 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.
PMID: 31628477DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Javier Gonzalez, PhD
University of Bath
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