Healthy SubjectsAivoPro1NCT01555385
The Effects of Breakfast on Mental Workload
A study testing Breakfast juice in people with Healthy Subjects, run by University of Helsinki at 1 site in Finland.
Trial summary
The aim of the study is to investigate the influence of nutritive (high-protein or high-carbohydrate) and non-nutritive (low energy) breakfast on psychological and physiological responses of mental workload during multitasking in healthy volunteers. Read more about this study
- Who is it for?
- Ages 22 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Subjects
- What is being tested?
- Breakfast juice
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 13 participants
- Where
- 1 siteFinland
- Study dates
- Sep 2011to 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 22 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- eats usually breakfast
- use computer mouse with right hand
- normal sleep-wake rhythm between 9 pm and 8 am
- in females hormonal contraception
Who cannot join
- gastrointestinal disease, diabetes or any other significant major medical morbidity
- milk allergy
- lactose intolerance
- smoking
- excess use of alcohol, coffee, tea, cola drinks (> 10 doses/day)
- pregnancy and breast feeding
- no medication or dietary supplements influencing measured responses
- BMI > 30 kg/m2 or < 18 kg/m2
Trial locations and contacts
1 site in 1 country.
Finland1 site
University of Helsinki, Institute of Biomedicine
Helsinki, 00014
About this study
Official title: The Effects of Nutritive and Non-nutritive Breakfast on Subjective Mental Workload During Multitasking - a Pilot Study in Healthy Volunteers
The aim of the study is to investigate the influence of nutritive (high-protein or high-carbohydrate) and non-nutritive (low energy) breakfast on psychological and physiological responses of mental workload during multitasking in healthy volunteers.
- Conditions
- Healthy Subjects
- Being tested
- Breakfast juice
- Keywords
- Mental workload, Multitasking, Protein, Tryptophan
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Breakfast juiceDietary supplement
single dose (300 ml) in the morning of study day, 3 separate sessions (high-protein vs. high-carbohydrate vs. low-calorie juice), total duration 3 weeks
| Study group | Role | What they receive |
|---|---|---|
| Dietary supplement: high-protein breakfast | Active comparator | high-protein juice Receives: Dietary Supplement: Breakfast juice |
| Dietary supplement: high-carbohydrate breakfast | Active comparator | high-carbohydrate juice Receives: Dietary Supplement: Breakfast juice |
| Dietary supplement: low energy breakfast | Placebo comparator | low-calorie juice Receives: Dietary Supplement: Breakfast juice |
What is being measured
The primary outcome is the main question the study is designed to answer.
Brain measures of mental workload (ERP 300 amplitude and latency) and heart rate
Measured: 1 day
Secondary outcomes (5)
Subjective mental workload and mood measurement assessed using visual analogue scale in response to test meal.
Measured: 1 day
cognitive function measurements
Measured: 1 day
Blood concentration of glucose
Measured: 1 day
salivary cortisol
Measured: 1 day
Blood concentration of tryptophan in relation to other large neutral amino acids
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2012 (estimated)
- Study startSep 2011
- Primary completionApr 2012
- Study completionMar 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy SubjectsStudies 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Helsinki
- Sponsor type
- University, hospital or other
- Collaborators
- Finnish Institute of Occupational Health, SalWe Ltd.
- Responsible party
- Principal investigator, Katri Peuhkuri, University of Helsinki
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01555385
- Sponsor's protocol ID
- UH-SHOK-001
- Acronym
- AivoPro1
- Status last verified
- Mar 2013
- First submitted
- 14 Mar 2012
- Last updated
- 6 Mar 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Nutritive and Non-nutritive Breakfast on Subjective Mental Workload During Multitasking - a Pilot Study in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT01555385
- Acronym / sponsor ID
- AivoPro1 / UH-SHOK-001
- Conditions
- Healthy Subjects
- Keywords
- Mental workload, Multitasking, Protein, Tryptophan
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- University of HelsinkiUniversity, hospital or other
- Collaborators
- Finnish Institute of Occupational Health, SalWe Ltd.
- Study start
- Sep 2011
- Primary completion
- Apr 2012 (actual)
- Study completion
- Mar 2013 (actual)
- First posted
- 15 Mar 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.
The aim of the study is to investigate the influence of nutritive (high-protein or high-carbohydrate) and non-nutritive (low energy) breakfast on psychological and physiological responses of mental workload during multitasking in healthy volunteers.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Dietary supplement: high-protein breakfast | Active comparator | Dietary Supplement: Breakfast juicehigh-protein juice |
| Dietary supplement: high-carbohydrate breakfast | Active comparator | Dietary Supplement: Breakfast juicehigh-carbohydrate juice |
| Dietary supplement: low energy breakfast | Placebo comparator | Dietary Supplement: Breakfast juicelow-calorie juice |
Who may qualify
- Ages
- 22 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- eats usually breakfast
- use computer mouse with right hand
- normal sleep-wake rhythm between 9 pm and 8 am
- in females hormonal contraception
Key exclusion criteria (8 listed)
- gastrointestinal disease, diabetes or any other significant major medical morbidity
- milk allergy
- lactose intolerance
- smoking
- excess use of alcohol, coffee, tea, cola drinks (> 10 doses/day)
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 juicesingle dose (300 ml) in the morning of study day, 3 separate sessions (high-protein vs. high-carbohydrate vs. low-calorie juice), total duration 3 weeks | Dietary supplement | Dietary supplement: high-carbohydrate breakfast, Dietary supplement: high-protein breakfast, Dietary supplement: low energy breakfast |
Primary outcome
Brain measures of mental workload (ERP 300 amplitude and latency) and heart rate
Time frame: 1 day
5 secondary outcomes
Subjective mental workload and mood measurement assessed using visual analogue scale in response to test meal.
Time frame: 1 day
cognitive function measurements
Time frame: 1 day
Blood concentration of glucose
Time frame: 1 day
salivary cortisol
Time frame: 1 day
Blood concentration of tryptophan in relation to other large neutral amino acids
Time frame: 1 day
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 6 Mar 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.
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 Breakfast juice in people with Healthy Subjects, run by University of Helsinki at 1 site in Finland.
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 6 Mar 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 Finland. 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?
Brain measures of mental workload (ERP 300 amplitude and latency) and heart rate (time frame: 1 day). 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 6 Mar 2013.