Energy BalanceNCT02258399
Exercise in the Fasted State, Glucose Metabolism and Energy Balance
A study testing Exercise and Breakfast in people with Energy Balance and Blood Glucose, run by University of Bath at 1 site in United Kingdom.
Trial 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. 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
- Energy Balance, Blood Glucose
- What is being tested?
- Exercise and Breakfast
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- May 2015to Dec 2017
- 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
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Department for Health, University of Bath
Bath, BA2 7AY
About this study
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.
- Conditions
- Energy Balance, Blood Glucose
- Being tested
- Exercise, Breakfast
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseBehavioural
Moderate intensity exercise
BreakfastDietary supplement
Breakfast consumption
| Study group | Role | What they receive |
|---|---|---|
| Breakfast Rest | Active comparator | Not described Receives: Dietary Supplement: Breakfast |
| Breakfast Exercise | Active comparator | Not described Receives: Behavioral: Exercise; Dietary Supplement: Breakfast |
| Fasted Exercise | Experimental | Not described Receives: Behavioral: Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Exogenous glucose appearance rate
Exogenous glucose appearance rates following an oral glucose tolerance test (total appearance over 120 minutes).
Measured: 120 minutes
Energy balance
Energy balance (intake minus expenditure) over 24 h from the beginning of the trial
Measured: 24 hours
Secondary outcomes (5)
Endogenous glucose appearance rates
Endogenous glucose appearance rates following an oral glucose tolerance test (total appearance over 120 minutes).
Measured: 120 minutes
Glucose clearance rates
Glucose clearance rates following an oral glucose tolerance test (total clearance over 120 minutes).
Measured: 120 minutes
Energy intake
Weighted energy intake over 24 hours from the beginning of the trial.
Measured: 24 h
Energy expenditure
Energy expenditure, derived from indirect calorimetry, acccelerometry and heart rate monitoring.
Measured: 24 h
Exogenous glucose appearance rates
Exogenous glucose appearance rates following an oral glucose tolerance test (total appearance over 120 minutes).
Measured: 120 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2014 (estimated)
- Study startMay 2015
- Primary completionJun 2016
- Study completionDec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Energy BalanceStudies 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
- Crossover
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Bath
- Sponsor type
- University, hospital or other
- Collaborators
- University of Stirling, University of Birmingham
- Responsible party
- Principal investigator, Javier Gonzalez, University of Bath
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02258399
- Sponsor's protocol ID
- RE-FH1109
- Status last verified
- Mar 2018
- First submitted
- 2 Oct 2014
- Last updated
- 2 Apr 2018
- Results posted
- No
Publications
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.
PubMed 24986552Gonzalez 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 23340006Allaf 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.
PubMed 33512717Edinburgh 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.
PubMed 31321428
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exercise in the Fasted State, Glucose Metabolism and Energy Balance
- ClinicalTrials.gov ID
- NCT02258399
- Acronym / sponsor ID
- RE-FH1109
- Conditions
- Energy Balance, Blood Glucose
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- University of BathUniversity, hospital or other
- Collaborators
- University of Stirling, University of Birmingham
- Study start
- May 2015
- Primary completion
- Jun 2016 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 7 Oct 2014 (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.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Breakfast Rest | Active comparator | Dietary Supplement: Breakfast |
| Breakfast Exercise | Active comparator | Behavioral: Exercise, Dietary Supplement: Breakfast |
| Fasted Exercise | Experimental | Behavioral: Exercise |
Who may qualify
- Ages
- 18 to 49 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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.
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 | Breakfast Exercise, Fasted Exercise |
| BreakfastBreakfast consumption | Dietary supplement | Breakfast Exercise, Breakfast Rest |
Primary outcome
Exogenous glucose appearance rate
Time frame: 120 minutes
Exogenous glucose appearance rates following an oral glucose tolerance test (total appearance over 120 minutes).
Energy balance
Time frame: 24 hours
Energy balance (intake minus expenditure) over 24 h from the beginning of the trial
5 secondary outcomes
Endogenous glucose appearance rates
Time frame: 120 minutes
Glucose clearance rates
Time frame: 120 minutes
Energy intake
Time frame: 24 h
Energy expenditure
Time frame: 24 h
Exogenous glucose appearance rates
Time frame: 120 minutes
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 2 Apr 2018.
- Background: PubMed 24986552Gonzalez 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.
- 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.
- Derived from this study: PubMed 33512717Allaf 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.
- Derived from this study: PubMed 31321428Edinburgh 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.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 and Breakfast in people with Energy Balance and Blood Glucose, 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 5 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 2 Apr 2018. 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?
Exogenous glucose appearance rate (time frame: 120 minutes). 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 NCT02258399, which also lists 4 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 2 Apr 2018.