FastingNCT00556868
The Influence of Having Breakfast on Cognitive Performance and Mood
A study testing Breakfast/no breakfast in people with Fasting, run by University of Ulm at 1 site in Germany.
Trial summary
Breakfast is often labelled the most important meal of the day. Parents and teachers quite often stress its importance for successful learning during the morning hours. With declining numbers of children and especially adolescents eating breakfast regularly, the study examines the influence of breakfast consumption on… Read more about this study
- Who is it for?
- Ages 13 to 20 yearsHealthy volunteers can take part
- Conditions the study is for
- Fasting
- What is being tested?
- Breakfast/no breakfast
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 104 participants
- Where
- 1 siteGermany
- Study dates
- Oct 2005to Dec 2005
- 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 13 to 20 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Healthy high school students
Who cannot join
- Diabetes
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Influence of Having Breakfast on Cognitive Performance and Mood in High School Students
Breakfast is often labelled the most important meal of the day.
Parents and teachers quite often stress its importance for successful learning during the morning hours. With declining numbers of children and especially adolescents eating breakfast regularly, the study examines the influence of breakfast consumption on cognition and mood of high school students.
- Conditions
- Fasting
- Being tested
- Breakfast/no breakfast
- Keywords
- High school students, Boarding school, Breakfast, Fasting, Memory, Attention, Mood
- Medical subject headings
- Fasting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Breakfast/no breakfastOther
A: Breakfast on the first day of intervention. Fasting (no breakfast) on the second day of intervention.
B: Breakfast on the second day of intervention. Fasting (no breakfast) on the first day of intervention
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | Breakfast on the first day of intervention, fasting (no breakfast) on the second day of intervention Receives: Other: Breakfast/no breakfast |
| B | Experimental | Fasting (no breakfast) on the first day of intervention, breakfast on the second day of intervention Receives: Other: Breakfast/no breakfast |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sustained attention, immediate memory, mood
Measured: 2 h
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Nov 2007 (estimated)
- Study startOct 2005
- Study completionDec 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for FastingStudies 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
- Single blind
- Who is masked
- Investigator
- Enrolment
- 104 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Ulm
- Sponsor type
- University, hospital or other
- Investigators
- Katharina A Widenhorn-Mueller, PhD, Principal investigator, Centre for Neuroscience and Learning, University of UlmKatrin Hille, PhD, Principal investigator, Centre for Neuroscience and Learning, University of UlmJochen Klenk, MPH, Principal investigator, Institute of Epidemiology, University of UlmWeiland Ulrike, MD, Principal investigator, Centre for Neuroscience and Learning, University of Ulm
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00556868
- Sponsor's protocol ID
- 241/2004
- Status last verified
- Nov 2007
- First submitted
- 9 Nov 2007
- Last updated
- 12 Nov 2007
- Results posted
- No
- Data monitoring committee
- No
Publications
Widenhorn-Muller K, Hille K, Klenk J, Weiland U. Influence of having breakfast on cognitive performance and mood in 13- to 20-year-old high school students: results of a crossover trial. Pediatrics. 2008 Aug;122(2):279-84. doi: 10.1542/peds.2007-0944.
PubMed 18676544
Study at a glance
From the registry record, last updated by the sponsor on 12 Nov 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Influence of Having Breakfast on Cognitive Performance and Mood in High School Students
- ClinicalTrials.gov ID
- NCT00556868
- Acronym / sponsor ID
- 241/2004
- Conditions
- Fasting
- Keywords
- High school students, Boarding school, Breakfast, Fasting, Memory, Attention, Mood
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 104 participants (actual)
- Lead sponsor
- University of UlmUniversity, hospital or other
- Study start
- Oct 2005
- Study completion
- Dec 2005 (actual)
- First posted
- 12 Nov 2007 (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.
Breakfast is often labelled the most important meal of the day.
Parents and teachers quite often stress its importance for successful learning during the morning hours. With declining numbers of children and especially adolescents eating breakfast regularly, the study examines the influence of breakfast consumption on cognition and mood of high school students.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Other: Breakfast/no breakfastBreakfast on the first day of intervention, fasting (no breakfast) on the second day of intervention |
| B | Experimental | Other: Breakfast/no breakfastFasting (no breakfast) on the first day of intervention, breakfast on the second day of intervention |
Who may qualify
- Ages
- 13 to 20 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Healthy high school students
Key exclusion criteria (1 listed)
- Diabetes
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/no breakfastA: Breakfast on the first day of intervention. Fasting (no breakfast) on the second day of intervention. B: Breakfast on the second day of intervention. Fasting (no breakfast) on the first day of intervention | Other | A, B |
Primary outcome
Sustained attention, immediate memory, mood
Time frame: 2 h
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 12 Nov 2007.
- Derived from this study: PubMed 18676544Widenhorn-Muller K, Hille K, Klenk J, Weiland U. Influence of having breakfast on cognitive performance and mood in 13- to 20-year-old high school students: results of a crossover trial. Pediatrics. 2008 Aug;122(2):279-84. doi: 10.1542/peds.2007-0944.
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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.
Katharina A Widenhorn-Mueller, PhD principal investigator
Centre for Neuroscience and Learning, University of Ulm
Katrin Hille, PhD principal investigator
Centre for Neuroscience and Learning, University of Ulm
Jochen Klenk, MPH principal investigator
Institute of Epidemiology, University of Ulm
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/no breakfast in people with Fasting, run by University of Ulm at 1 site in Germany.
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 1 inclusion and 1 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 12 Nov 2007. 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 Germany. 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?
Sustained attention, immediate memory, mood (time frame: 2 h). 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 NCT00556868, which also lists 1 linked publication.
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 12 Nov 2007.