Glucose Metabolism DisordersNCT02744183
Training in the Fasted State, Glucose Metabolism and Energy Balance
A study testing Exercise, Breakfast and Maintain habitual habits in people with Glucose Metabolism Disorders, run by University of Bath at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 49 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Glucose Metabolism Disorders
- What is being tested?
- Exercise, Breakfast and Maintain habitual habits
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Oct 2016to Sep 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 49 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Department for Health, University of Bath
Bath, BA2 7AY
About this study
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.
- Conditions
- Glucose Metabolism Disorders
- Being tested
- Exercise, Breakfast, Maintain habitual habits
- Keywords
- Exercise, Fasted, Glucose, Energy Balance
- Medical subject headings
- Glucose Metabolism Disorders, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseBehavioural
Moderate intensity exercise
BreakfastBehavioural
Breakfast consumption
Maintain habitual habitsBehavioural
Normal physical activity and dietary behaviors maintained
| Study group | Role | What they receive |
|---|---|---|
| Control Group | Active comparator | Maintain habitual habits Receives: Behavioral: Maintain habitual habits |
| Fed Exercise | Active comparator | 6 weeks of moderate intensity exercise with breakfast consumption Receives: Behavioral: Exercise; Behavioral: Breakfast |
| Fasted Exercise | Experimental | 6 weeks of moderate intensity exercise with breakfast omission Receives: Behavioral: Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postprandial plasma glucose concentrations
Response to oral glucose tolerance test (area under the curve)
Measured: 120 mins - (change after 6 weeks)
Postprandial insulin concentrations
Response to oral glucose tolerance test (area under the curve)
Measured: 120 mins - (change after 6 weeks)
Secondary outcomes (29)
Oral Glucose Insulin Sensitivity Index
Response to oral glucose tolerance test
Measured: 120 mins - (change after 6 weeks)
Cardiorespiratory fitness (VO2max)
Measured: Change after 6 weeks
Habitual energy intake
Assessed via a food diary, completed at baseline and during the last week of the intervention
Measured: Change after 6 weeks
Habitual energy expenditure
Assessed via an Actiheart monitor, completed at baseline and during the last week of the intervention
Measured: Change after 6 weeks
Body mass (kg)
Measured: Change after 6 weeks
Waist and hip circumference (cm)
Measured: Change after 6 weeks
Maximal rate of whole-body lipid oxidation (g/min)
During an incremental exercise test
Measured: Change after 6 weeks
Fasting plasma glucose concentration
Fasting plasma glucose concentration (mmol/L)
Measured: Basal Concentrations - (change after 6 weeks)
Fasting plasma insulin concentration
Fasting plasma insulin concentration (pmol/L)
Measured: Basal Concentrations - (change after 6 weeks)
Postprandial non-esterified fatty acid concentrations
Response to oral glucose tolerance test (total and incremental area under the curve)
Measured: 120 mins - (change after 6 weeks)
Fasting plasma triglyceride concentrations
Fasting plasma triglyceride concentrations (mmol/L)
Measured: Basal Concentrations - (change after 6 weeks)
Fasting plasma total cholesterol concentrations
Fasting plasma total cholesterol concentrations (mmol/L)
Measured: Basal Concentrations - (change after 6 weeks)
Fasting plasma HDL cholesterol concentrations
Fasting plasma HDL cholesterol concentrations (mmol/L)
Measured: Basal Concentrations - (change after 6 weeks)
Fasting plasma LDL cholesterol concentrations
Fasting plasma LDL cholesterol concentrations (mmol/L)
Measured: Basal Concentrations - (change after 6 weeks)
Fasting plasma non-esterified fatty acid concentrations
Fasting plasma non-esterified fatty acid concentrations (mmol/L)
Measured: Basal Concentrations - (change after 6 weeks)
Waist to hip ratio
Waist circumference (cm) divided by hip circumference (cm)
Measured: Change after 6 weeks
Citrate Synthase Activity (mitochondrial citrate synthase activity in each muscle sample in an immunocapture based manner)
Skeletal muscle (vastus lateralis). Citrate Synthase Activity Assay Kit.
Measured: Change after 6 weeks
Protein content of mitochondrial respiratory chain proteins
Skeletal muscle (vastus lateralis). Complex I, Complex II, Complex III, Complex IV.
Measured: 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)
Skeletal muscle (vastus lateralis)
Measured: 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)
Skeletal muscle (vastus lateralis)
Measured: 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)
Skeletal muscle (vastus lateralis)
Measured: 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)
Assessed via indirect calirometry
Measured: Change after 6 weeks
Energy balance
Total energy expenditure minus total energy intake
Measured: Change after 6 weeks (during week 6 of intervention versus baseline monitoring)
Whole-body lipid utilisation during exercise
Assessed via indirect calirometry during every exercise session (at ten minute intervals)
Measured: Change throughout complete training period (weeks 1 through to 6). Samples will be collected during every training session (three times weekly for six weeks)
Whole-body carbohydrate utilisation during exercise
Assessed via indirect calirometry during every exercise session (at ten minute intervals)
Measured: Change throughout complete training period (weeks 1 through to 6). Samples will be collected during every training session (three times weekly for six weeks)
Homeostasis Model Assessment (HOMA2-IR)
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.
Measured: Change after 6 weeks
Fasting plasma glycerol concentrations
Fasting plasma glycerol concentrations (mmol/L)
Measured: Basal Concentrations - (change after 6 weeks)
Postprandial plasma glycerol concentrations
Response to oral glucose tolerance test (total and incremental area under the curve)
Measured: Change after 6 weeks
Adipose Tissue Insulin Resistance Index (Adipo-IR)
Response to oral glucose tolerance test (total and incremental area under the curve)
Measured: Change after 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2016 (estimated)
- Study startOct 2016
- Primary completionAug 2018
- Study completionSep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Glucose Metabolism DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Bath
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Javier Gonzalez, University of Bath
- Investigators
- Javier Gonzalez, PhD, Principal investigator, University of Bath
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02744183
- Sponsor's protocol ID
- EP 15/16129
- Status last verified
- Nov 2022
- First submitted
- 11 Apr 2016
- Last updated
- 25 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
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.
PubMed 23340006Van 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.
PubMed 20837645Edinburgh 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.
PubMed 31628477
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Training in the Fasted State, Glucose Metabolism and Energy Balance
- ClinicalTrials.gov ID
- NCT02744183
- Acronym / sponsor ID
- EP 15/16129
- Conditions
- Glucose Metabolism Disorders
- Keywords
- Exercise, Fasted, Glucose, Energy Balance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of BathUniversity, hospital or other
- Study start
- Oct 2016 (actual)
- Primary completion
- Aug 2018 (actual)
- Study completion
- Sep 2019 (actual)
- First posted
- 20 Apr 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control Group | Active comparator | Behavioral: Maintain habitual habitsMaintain habitual habits |
| Fed Exercise | Active comparator | Behavioral: Exercise, Behavioral: Breakfast6 weeks of moderate intensity exercise with breakfast consumption |
| Fasted Exercise | Experimental | Behavioral: Exercise6 weeks of moderate intensity exercise with breakfast omission |
Who may qualify
- Ages
- 18 to 49 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ExerciseModerate intensity exercise | Behavioural | Fasted Exercise, Fed Exercise |
| BreakfastBreakfast consumption | Behavioural | Fed Exercise |
| Maintain habitual habitsNormal physical activity and dietary behaviors maintained | Behavioural | Control Group |
Primary outcome
Postprandial plasma glucose concentrations
Time frame: 120 mins - (change after 6 weeks)
Response to oral glucose tolerance test (area under the curve)
Postprandial insulin concentrations
Time frame: 120 mins - (change after 6 weeks)
Response to oral glucose tolerance test (area under the curve)
29 secondary outcomes
Oral Glucose Insulin Sensitivity Index
Time frame: 120 mins - (change after 6 weeks)
Cardiorespiratory fitness (VO2max)
Time frame: Change after 6 weeks
Habitual energy intake
Time frame: Change after 6 weeks
Habitual energy expenditure
Time frame: Change after 6 weeks
Body mass (kg)
Time frame: Change after 6 weeks
Waist and hip circumference (cm)
Time frame: Change after 6 weeks
Maximal rate of whole-body lipid oxidation (g/min)
Time frame: Change after 6 weeks
Fasting plasma glucose concentration
Time frame: Basal Concentrations - (change after 6 weeks)
Fasting plasma insulin concentration
Time frame: Basal Concentrations - (change after 6 weeks)
Postprandial non-esterified fatty acid concentrations
Time frame: 120 mins - (change after 6 weeks)
Fasting plasma triglyceride concentrations
Time frame: Basal Concentrations - (change after 6 weeks)
Fasting plasma total cholesterol concentrations
Time frame: Basal Concentrations - (change after 6 weeks)
Fasting plasma HDL cholesterol concentrations
Time frame: Basal Concentrations - (change after 6 weeks)
Fasting plasma LDL cholesterol concentrations
Time frame: Basal Concentrations - (change after 6 weeks)
Fasting plasma non-esterified fatty acid concentrations
Time frame: Basal Concentrations - (change after 6 weeks)
Waist to hip ratio
Time frame: 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
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).
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)
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)
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)
Resting metabolic rate (RMR)
Time frame: Change after 6 weeks
Energy balance
Time frame: Change after 6 weeks (during week 6 of intervention versus baseline monitoring)
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)
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)
Homeostasis Model Assessment (HOMA2-IR)
Time frame: Change after 6 weeks
Fasting plasma glycerol concentrations
Time frame: Basal Concentrations - (change after 6 weeks)
Postprandial plasma glycerol concentrations
Time frame: Change after 6 weeks
Adipose Tissue Insulin Resistance Index (Adipo-IR)
Time frame: Change after 6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2022.
- Background: PubMed 23340006Gonzalez 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.
- Background: PubMed 20837645Van 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.
- Derived from this study: PubMed 31628477Edinburgh 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Javier Gonzalez, PhD principal investigator
University of Bath
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise, Breakfast and Maintain habitual habits in people with Glucose Metabolism Disorders, run by University of Bath at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postprandial plasma glucose concentrations (time frame: 120 mins - (change after 6 weeks)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02744183, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Nov 2022.