Energy Balance,NCT01229345
Effect of Exercise With or Without Breakfast, on Metabolism, Appetite and Cognition
A study testing Breakfast & exercise in people with Energy Balance, and Appetite,, run by Northumbria University at 1 site in United Kingdom.
Trial summary
The purpose of this study is to assess the effect of eating breakfast in combination with exercise on fat usage, appetite and brain performance later in the day. Read more about this study
- Who is it for?
- Ages 18 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Energy Balance,, Appetite,, Cognitive Function.
- What is being tested?
- Breakfast & exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Oct 2010to Jul 2011
- 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 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male
- Aged 18-45 years
- BMI 18.5-24.9 kg/m2
- Physically active: able to run for 1 h at a moderate pace
- Healthy
Who cannot join
- Smokers
- Food allergies
- Metabolic disorders
- Restrained eaters (equivalent of >7 for restrained on TFEQ)
- Consuming herbal/dietary supplements
- History of head trauma
Show all 11Show fewer
- Learning difficulties
- ADHD
- Dyslexia
- History of migraines
- Gastric problems
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Brain, Performance and Nutrition Centre, Northumbria University
Newcastle upon Tyne, Tyne and Wear, NE1 8ST
About this study
Official title: The Interactive Effect of Breakfast Consumption and Exercise on Metabolism, Appetite and Cognitive Function
The purpose of this study is to assess the effect of eating breakfast in combination with exercise on fat usage, appetite and brain performance later in the day.
- Conditions
- Energy Balance,, Appetite,, Cognitive Function.
- Being tested
- Breakfast & exercise
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Breakfast & exerciseDrug
1859 kJ breakfast vs fast, exercise at 60% maximum aerobic capacity to expend 1859 kJ.
| Study group | Role | What they receive |
|---|---|---|
| Breakfast & exercise | Experimental | Not described Receives: Drug: Breakfast & exercise |
| Breakfast & no exercise | Experimental | Not described Receives: Drug: Breakfast & exercise |
| No breakfast & exercise | Experimental | Not described Receives: Drug: Breakfast & exercise |
| No breakfast & no exercise | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Energy balance
Energy balance (kJ/kcal) will be assessed by an ad libitum test meal provided at 5 h minus energy expenditure estimated by indirect calorimetry.
Measured: 24 h
Secondary outcomes (6)
Blood glucose
Measured: 1.5 h area under the curve, post-consumption of a liquid snack
Serum insulin
Measured: 1.5 h area under the curve, post-consumption of a liquid snack
Subjective appetite ratings
Participants will be asked to complete visual analogue scales (VAS).
Measured: 1.5 h area under the curve, post-consumption of a liquid snack and following an ad libitum test meal
Cognitive function measurements
Reaction time, short-term memory, speed of processing, attention.
Measured: 1.5 h area under the curve, post-consumption of a liquid snack and following an ad libitum test meal
Mood
Participants will be asked to complete visual analogue scales (VAS).
Measured: 1.5 h area under the curve, post-consumption of a liquid snack and following an ad libitum test meal
Energy expenditure
Measured by indirect calorimetry
Measured: 1.5 h mean following a liquid snack
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2010 (estimated)
- Study startOct 2010
- Primary completionJul 2011
- Study completionJul 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Energy Balance,Studies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northumbria University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Javier Gonzalez, Northumbria University
- Investigators
- Emma J Stevenson, PhD, Principal investigator, Northumbria University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01229345
- Sponsor's protocol ID
- 32W3
- Status last verified
- May 2012
- First submitted
- 12 Oct 2010
- Last updated
- 4 May 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Interactive Effect of Breakfast Consumption and Exercise on Metabolism, Appetite and Cognitive Function
- ClinicalTrials.gov ID
- NCT01229345
- Acronym / sponsor ID
- 32W3
- Conditions
- Energy Balance,, Appetite,, Cognitive Function.
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Northumbria UniversityUniversity, hospital or other
- Study start
- Oct 2010
- Primary completion
- Jul 2011 (actual)
- Study completion
- Jul 2011 (actual)
- First posted
- 27 Oct 2010 (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 purpose of this study is to assess the effect of eating breakfast in combination with exercise on fat usage, appetite and brain performance later in the day.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Breakfast & exercise | Experimental | Drug: Breakfast & exercise |
| Breakfast & no exercise | Experimental | Drug: Breakfast & exercise |
| No breakfast & exercise | Experimental | Drug: Breakfast & exercise |
| No breakfast & no exercise | No intervention | – |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Male
- Aged 18-45 years
- BMI 18.5-24.9 kg/m2
- Physically active: able to run for 1 h at a moderate pace
- Healthy
Key exclusion criteria (11 listed)
- Smokers
- Food allergies
- Metabolic disorders
- Restrained eaters (equivalent of >7 for restrained on TFEQ)
- Consuming herbal/dietary supplements
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 |
|---|---|---|
| Breakfast & exercise1859 kJ breakfast vs fast, exercise at 60% maximum aerobic capacity to expend 1859 kJ. | Drug | Breakfast & exercise, Breakfast & no exercise, No breakfast & exercise |
Primary outcome
Energy balance
Time frame: 24 h
Energy balance (kJ/kcal) will be assessed by an ad libitum test meal provided at 5 h minus energy expenditure estimated by indirect calorimetry.
6 secondary outcomes
Blood glucose
Time frame: 1.5 h area under the curve, post-consumption of a liquid snack
Serum insulin
Time frame: 1.5 h area under the curve, post-consumption of a liquid snack
Subjective appetite ratings
Time frame: 1.5 h area under the curve, post-consumption of a liquid snack and following an ad libitum test meal
Cognitive function measurements
Time frame: 1.5 h area under the curve, post-consumption of a liquid snack and following an ad libitum test meal
Mood
Time frame: 1.5 h area under the curve, post-consumption of a liquid snack and following an ad libitum test meal
Energy expenditure
Time frame: 1.5 h mean following a liquid snack
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 4 May 2012.
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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.
Emma J Stevenson, PhD principal investigator
Northumbria University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Breakfast & exercise in people with Energy Balance, and Appetite,, run by Northumbria University 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 11 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 4 May 2012. 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?
Energy balance (time frame: 24 h). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 May 2012.