Healthy Subjects Clinical Trial
— AivoPro1Official title:
The Effects of Nutritive and Non-nutritive Breakfast on Subjective Mental Workload During Multitasking - a Pilot Study in Healthy Volunteers
Verified date | March 2013 |
Source | Helsinki University |
Contact | n/a |
Is FDA regulated | No |
Health authority | Finland: HUS ethics comittee |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 13 |
Est. completion date | March 2013 |
Est. primary completion date | April 2012 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 22 Years to 45 Years |
Eligibility |
Inclusion Criteria: - eats usually breakfast - use computer mouse with right hand - normal sleep-wake rhythm between 9 pm and 8 am - in females hormonal contraception Exclusion Criteria: - 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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Basic Science
Country | Name | City | State |
---|---|---|---|
Finland | University of Helsinki, Institute of Biomedicine | Helsinki |
Lead Sponsor | Collaborator |
---|---|
Helsinki University | Finnish Institute of Occupational Health, SalWe Ltd. |
Finland,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Brain measures of mental workload (ERP 300 amplitude and latency) and heart rate | 1 day | No | |
Secondary | Subjective mental workload and mood measurement assessed using visual analogue scale in response to test meal. | 1 day | No | |
Secondary | cognitive function measurements | 1 day | No | |
Secondary | Blood concentration of glucose | 1 day | No | |
Secondary | salivary cortisol | 1 day | No | |
Secondary | Blood concentration of tryptophan in relation to other large neutral amino acids | 1 day | No |
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