The Effects of Breakfast on Mental Workload
AivoPro1
The Effects of Nutritive and Non-nutritive Breakfast on Subjective Mental Workload During Multitasking - a Pilot Study in Healthy Volunteers
1 other identifier
interventional
13
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Sep 2011
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2011
CompletedFirst Submitted
Initial submission to the registry
March 14, 2012
CompletedFirst Posted
Study publicly available on registry
March 15, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2013
CompletedMarch 6, 2013
March 1, 2013
7 months
March 14, 2012
March 5, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Brain measures of mental workload (ERP 300 amplitude and latency) and heart rate
1 day
Secondary Outcomes (5)
Subjective mental workload and mood measurement assessed using visual analogue scale in response to test meal.
1 day
cognitive function measurements
1 day
Blood concentration of glucose
1 day
salivary cortisol
1 day
Blood concentration of tryptophan in relation to other large neutral amino acids
1 day
Study Arms (3)
Dietary supplement: high-protein breakfast
ACTIVE COMPARATORhigh-protein juice
Dietary supplement: high-carbohydrate breakfast
ACTIVE COMPARATORhigh-carbohydrate juice
Dietary supplement: low energy breakfast
PLACEBO COMPARATORlow-calorie juice
Interventions
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
Eligibility Criteria
You may qualify if:
- eats usually breakfast
- use computer mouse with right hand
- normal sleep-wake rhythm between 9 pm and 8 am
- in females hormonal contraception
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Helsinkilead
- Finnish Institute of Occupational Healthcollaborator
- SalWe Ltd.collaborator
Study Sites (1)
University of Helsinki, Institute of Biomedicine
Helsinki, 00014, Finland
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- BASIC SCIENCE
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal investigator, postdoctoral reseacher, authorized nutritionist
Study Record Dates
First Submitted
March 14, 2012
First Posted
March 15, 2012
Study Start
September 1, 2011
Primary Completion
April 1, 2012
Study Completion
March 1, 2013
Last Updated
March 6, 2013
Record last verified: 2013-03