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NCT01555385 Clinical Trial

The Effects of Breakfast on Mental Workload

Healthy Subjects Clinical Trial

— AivoPro1  

Official title:
The Effects of Nutritive and Non-nutritive Breakfast on Subjective Mental Workload During Multitasking - a Pilot Study in Healthy Volunteers

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01555385
Other study ID # UH-SHOK-001
Secondary ID
Status Completed
Phase N/A
First received March 14, 2012
Last updated March 5, 2013
Start date September 2011
Est. completion date March 2013

Study information
Verified date March 2013
Source Helsinki University
Contact n/a
Is FDA regulated No
Health authority Finland: HUS ethics comittee
Study type Interventional

Clinical 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.

Recruitment information / eligibility
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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Basic Science

Related Conditions & MeSH terms

Intervention

Dietary Supplement:
• Breakfast juice
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

Locations
Country Name City State
Finland University of Helsinki, Institute of Biomedicine Helsinki

Sponsors (3)
Lead Sponsor Collaborator
Helsinki University Finnish Institute of Occupational Health, SalWe Ltd.

Country where clinical trial is conducted

Finland, 

Outcome
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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