- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02744183
Training in the Fasted State, Glucose Metabolism and Energy Balance
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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Bath, United Kingdom, BA2 7AY
- Department for Health, University of Bath
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Control Group
Maintain habitual habits
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Normal physical activity and dietary behaviors maintained
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Active Comparator: Fed Exercise
6 weeks of moderate intensity exercise with breakfast consumption
|
Moderate intensity exercise
Breakfast consumption
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Experimental: Fasted Exercise
6 weeks of moderate intensity exercise with breakfast omission
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Moderate intensity exercise
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Postprandial plasma glucose concentrations
Time Frame: 120 mins - (change after 6 weeks)
|
Response to oral glucose tolerance test (area under the curve)
|
120 mins - (change after 6 weeks)
|
Postprandial insulin concentrations
Time Frame: 120 mins - (change after 6 weeks)
|
Response to oral glucose tolerance test (area under the curve)
|
120 mins - (change after 6 weeks)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Oral Glucose Insulin Sensitivity Index
Time Frame: 120 mins - (change after 6 weeks)
|
Response to oral glucose tolerance test
|
120 mins - (change after 6 weeks)
|
Cardiorespiratory fitness (VO2max)
Time Frame: Change after 6 weeks
|
Change after 6 weeks
|
|
Habitual energy intake
Time Frame: Change after 6 weeks
|
Assessed via a food diary, completed at baseline and during the last week of the intervention
|
Change after 6 weeks
|
Habitual energy expenditure
Time Frame: Change after 6 weeks
|
Assessed via an Actiheart monitor, completed at baseline and during the last week of the intervention
|
Change after 6 weeks
|
Body mass (kg)
Time Frame: Change after 6 weeks
|
Change after 6 weeks
|
|
Waist and hip circumference (cm)
Time Frame: Change after 6 weeks
|
Change after 6 weeks
|
|
Maximal rate of whole-body lipid oxidation (g/min)
Time Frame: Change after 6 weeks
|
During an incremental exercise test
|
Change after 6 weeks
|
Fasting plasma glucose concentration
Time Frame: Basal Concentrations - (change after 6 weeks)
|
Fasting plasma glucose concentration (mmol/L)
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Basal Concentrations - (change after 6 weeks)
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Fasting plasma insulin concentration
Time Frame: Basal Concentrations - (change after 6 weeks)
|
Fasting plasma insulin concentration (pmol/L)
|
Basal Concentrations - (change after 6 weeks)
|
Postprandial non-esterified fatty acid concentrations
Time Frame: 120 mins - (change after 6 weeks)
|
Response to oral glucose tolerance test (total and incremental area under the curve)
|
120 mins - (change after 6 weeks)
|
Fasting plasma triglyceride concentrations
Time Frame: Basal Concentrations - (change after 6 weeks)
|
Fasting plasma triglyceride concentrations (mmol/L)
|
Basal Concentrations - (change after 6 weeks)
|
Fasting plasma total cholesterol concentrations
Time Frame: Basal Concentrations - (change after 6 weeks)
|
Fasting plasma total cholesterol concentrations (mmol/L)
|
Basal Concentrations - (change after 6 weeks)
|
Fasting plasma HDL cholesterol concentrations
Time Frame: Basal Concentrations - (change after 6 weeks)
|
Fasting plasma HDL cholesterol concentrations (mmol/L)
|
Basal Concentrations - (change after 6 weeks)
|
Fasting plasma LDL cholesterol concentrations
Time Frame: Basal Concentrations - (change after 6 weeks)
|
Fasting plasma LDL cholesterol concentrations (mmol/L)
|
Basal Concentrations - (change after 6 weeks)
|
Fasting plasma non-esterified fatty acid concentrations
Time Frame: Basal Concentrations - (change after 6 weeks)
|
Fasting plasma non-esterified fatty acid concentrations (mmol/L)
|
Basal Concentrations - (change after 6 weeks)
|
Waist to hip ratio
Time Frame: Change after 6 weeks
|
Waist circumference (cm) divided by hip circumference (cm)
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Change after 6 weeks
|
Citrate Synthase Activity (mitochondrial citrate synthase activity in each muscle sample in an immunocapture based manner)
Time Frame: Change after 6 weeks
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Skeletal muscle (vastus lateralis).
Citrate Synthase Activity Assay Kit.
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Change after 6 weeks
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Protein content of mitochondrial respiratory chain proteins
Time Frame: Change after 6 weeks. For each participant the protein content will be presented as the fold change from baseline (arbitrary units).
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Skeletal muscle (vastus lateralis).
Complex I, Complex II, Complex III, Complex IV.
|
Change after 6 weeks. For each participant the protein content will be presented as the fold change from baseline (arbitrary units).
|
Protein content of carnitine palmitoyltransferase I (CPT-1)
Time Frame: Change after 6 weeks. For each participant the protein content will be presented as the fold change from baseline (arbitrary units)
|
Skeletal muscle (vastus lateralis)
|
Change after 6 weeks. For each participant the protein content will be presented as the fold change from baseline (arbitrary units)
|
Protein content of cluster of differentiation 36 (CD36)
Time Frame: Change after 6 weeks. For each participant the protein content will be presented as the fold change from baseline (arbitrary units)
|
Skeletal muscle (vastus lateralis)
|
Change after 6 weeks. For each participant the protein content will be presented as the fold change from baseline (arbitrary units)
|
Protein content (total and phosphorylated form) of AMP-activated protein kinase (AMPK)
Time Frame: Change after 6 weeks. For each participant the protein content will be presented as the fold change from baseline (arbitrary units)
|
Skeletal muscle (vastus lateralis)
|
Change after 6 weeks. For each participant the protein content will be presented as the fold change from baseline (arbitrary units)
|
Resting metabolic rate (RMR)
Time Frame: Change after 6 weeks
|
Assessed via indirect calirometry
|
Change after 6 weeks
|
Energy balance
Time Frame: Change after 6 weeks (during week 6 of intervention versus baseline monitoring)
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Total energy expenditure minus total energy intake
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Change after 6 weeks (during week 6 of intervention versus baseline monitoring)
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Whole-body lipid utilisation during exercise
Time Frame: Change throughout complete training period (weeks 1 through to 6). Samples will be collected during every training session (three times weekly for six weeks)
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Assessed via indirect calirometry during every exercise session (at ten minute intervals)
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Change throughout complete training period (weeks 1 through to 6). Samples will be collected during every training session (three times weekly for six weeks)
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Whole-body carbohydrate utilisation during exercise
Time Frame: Change throughout complete training period (weeks 1 through to 6). Samples will be collected during every training session (three times weekly for six weeks)
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Assessed via indirect calirometry during every exercise session (at ten minute intervals)
|
Change throughout complete training period (weeks 1 through to 6). Samples will be collected during every training session (three times weekly for six weeks)
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Homeostasis Model Assessment (HOMA2-IR)
Time Frame: Change after 6 weeks
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The Homeostasis Model Assessment (HOMA) estimate of steady state beta cell function (%B) and insulin sensitivity (%S).
Derived from fasting plasma glucose and fasting plasma insulin concentrations.
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Change after 6 weeks
|
Fasting plasma glycerol concentrations
Time Frame: Basal Concentrations - (change after 6 weeks)
|
Fasting plasma glycerol concentrations (mmol/L)
|
Basal Concentrations - (change after 6 weeks)
|
Postprandial plasma glycerol concentrations
Time Frame: Change after 6 weeks
|
Response to oral glucose tolerance test (total and incremental area under the curve)
|
Change after 6 weeks
|
Adipose Tissue Insulin Resistance Index (Adipo-IR)
Time Frame: Change after 6 weeks
|
Response to oral glucose tolerance test (total and incremental area under the curve)
|
Change after 6 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Javier Gonzalez, PhD, University of Bath
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- EP 15/16129
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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