Alteration of Cognitive FunctionNCT01711008
The Effect of Breakfast Size Prior to Morning Exercise on Cognition, Mood and Appetite in Habitually Active Women
A study testing Cereal and No breakfast in people with Alteration of Cognitive Function, run by Northumbria University at 1 site in United Kingdom.
Trial summary
Both regular exercise and breakfast consumption have well known health benefits. Consuming breakfast prior to morning exercise may influence appetite, mood and cognitive function later in the day. Read more about this study
- Who is it for?
- Ages 18 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Alteration of Cognitive Function
- What is being tested?
- Cereal and No breakfast
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Sep 2012to Mar 2013
- 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 35 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Must be habitually active (exercising for least 30 minutes, 3 times per week for at least the previous 6 months)
- Must have a normal exercise routine includes a minimum of 1 morning exercise session (which takes place between 6am-11am) each week
- Must run on a regular basis (at least once per week) and be able to run at a moderate pace for 30 minutes non-stop on a treadmill
- Must consume breakfast on most days of the week, usually consume breakfast before undertaking a morning exercise session and be comfortable consuming a bowl of cereal 45mins before running
Who cannot join
- English not first language
- Smoking
- Previous or current eating disorders, metabolic disorders, gastric problems or any contraindications of exercise.
- Pregnancy
- The habitual use of some prescription or over the counter medications (excluding contraception) or herbal/dietary supplements (please ask the researcher)
- A history of or current learning difficulties, ADHD or dyslexia
- Daily use of an inhaler to control asthma
- Allergies or intolerances to any of the foods provided in the study (Special K cereal, semi-skimmed milk, pasta, tomato sauce, cheese, olive oil, rice, custard)
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Brain, Performance and Nutrition Research Centre, Northumbria Univerity
Newcastle upon Tyne, Tyne and Wear, NE19ST
About this study
Official title: The Effect of Breakfast Size Prior to Morning Exercise on Cognition, Mood and Appetite Later in the Day in Habitually Active Women
Both regular exercise and breakfast consumption have well known health benefits. Consuming breakfast prior to morning exercise may influence appetite, mood and cognitive function later in the day. The purpose of this study is to test whether the amount of food consumed at breakfast prior to exercise influences these parameters in active women.
- Conditions
- Alteration of Cognitive Function
- Being tested
- Cereal, No breakfast
- Keywords
- Breakfast size, Exercise, Cognitive performance, Mood, Appetite, Active women
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CerealDietary supplement
Also called Breakfast cereal
No breakfastDietary supplement
| Study group | Role | What they receive |
|---|---|---|
| No Breakfast | Placebo comparator | Water only Receives: Dietary Supplement: No breakfast |
| 20g Cereal | Active comparator | 20g Kelloggs Special K cereal with 83ml semi-skimmed milk Receives: Dietary Supplement: Cereal |
| 40g Cereal | Active comparator | 40g Kelloggs Special K cereal with 166ml semi-skimmed milk Receives: Dietary Supplement: Cereal |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cognitive function change from baseline scores
Participants will complete 4 cognitive tasks (Four Choice Reaction Time, NBack, Stroop and RVIP) measuring reaction time, short-term memory, speed of processing and attention.
Measured: Assessed hourly until 4.5 hours and at 6.5 and 10.5 hours
Secondary outcomes (1)
Mood change from baseline scores
Mood will be assessed using Visual Analogue Scales (VAS) immediately before and after each set of cognitive tasks.
Measured: Assessed hourly until 4.5 hours and at 6.5 and 10.5 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2012 (estimated)
- Study startSep 2012
- Primary completionMar 2013
- Study completionMar 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alteration of Cognitive FunctionStudies 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
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northumbria University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rachel Veasey, Northumbria University
- Investigators
- Rachel Veasey, Principal investigator, Northumbria University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01711008
- Sponsor's protocol ID
- 29W5
- Status last verified
- Apr 2013
- First submitted
- 25 Sep 2012
- Last updated
- 1 May 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Breakfast Size Prior to Morning Exercise on Cognition, Mood and Appetite Later in the Day in Habitually Active Women
- ClinicalTrials.gov ID
- NCT01711008
- Acronym / sponsor ID
- 29W5
- Conditions
- Alteration of Cognitive Function
- Keywords
- Breakfast size, Exercise, Cognitive performance, Mood, Appetite, Active women
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Northumbria UniversityUniversity, hospital or other
- Study start
- Sep 2012
- Primary completion
- Mar 2013 (actual)
- Study completion
- Mar 2013 (actual)
- First posted
- 19 Oct 2012 (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.
Both regular exercise and breakfast consumption have well known health benefits. Consuming breakfast prior to morning exercise may influence appetite, mood and cognitive function later in the day. The purpose of this study is to test whether the amount of food consumed at breakfast prior to exercise influences these parameters in active women.
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| No Breakfast | Placebo comparator | Dietary Supplement: No breakfastWater only |
| 20g Cereal | Active comparator | Dietary Supplement: Cereal20g Kelloggs Special K cereal with 83ml semi-skimmed milk |
| 40g Cereal | Active comparator | Dietary Supplement: Cereal40g Kelloggs Special K cereal with 166ml semi-skimmed milk |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Must be habitually active (exercising for least 30 minutes, 3 times per week for at least the previous 6 months)
- Must have a normal exercise routine includes a minimum of 1 morning exercise session (which takes place between 6am-11am) each week
- Must run on a regular basis (at least once per week) and be able to run at a moderate pace for 30 minutes non-stop on a treadmill
- Must consume breakfast on most days of the week, usually consume breakfast before undertaking a morning exercise session and be comfortable consuming a bowl of cereal 45mins before running
Key exclusion criteria (8 listed)
- English not first language
- Smoking
- Previous or current eating disorders, metabolic disorders, gastric problems or any contraindications of exercise.
- Pregnancy
- The habitual use of some prescription or over the counter medications (excluding contraception) or herbal/dietary supplements (please ask the researcher)
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 |
|---|---|---|
| CerealAlso: Breakfast cereal | Dietary supplement | 20g Cereal, 40g Cereal |
| No breakfast | Dietary supplement | No Breakfast |
Primary outcome
Cognitive function change from baseline scores
Time frame: Assessed hourly until 4.5 hours and at 6.5 and 10.5 hours
Participants will complete 4 cognitive tasks (Four Choice Reaction Time, NBack, Stroop and RVIP) measuring reaction time, short-term memory, speed of processing and attention.
1 secondary outcome
Mood change from baseline scores
Time frame: Assessed hourly until 4.5 hours and at 6.5 and 10.5 hours
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 1 May 2013.
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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.
Rachel Veasey 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 Cereal and No breakfast in people with Alteration of Cognitive Function, 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 4 inclusion and 8 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 1 May 2013. 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. Some participants in this study may receive a placebo. 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?
Cognitive function change from baseline scores (time frame: Assessed hourly until 4.5 hours and at 6.5 and 10.5 hours). 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 1 May 2013.