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The Effects of Breakfast on Mental Workload (AivoPro1)

This study has been completed.
Sponsor:
Collaborators:
Finnish Institute of Occupational Health
SalWe Ltd
Information provided by (Responsible Party):
Katri Peuhkuri, Helsinki University
ClinicalTrials.gov Identifier:
NCT01555385
First received: March 14, 2012
Last updated: March 5, 2013
Last verified: March 2013
History of Changes
  Purpose

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.


Condition Intervention
Healthy Subjects
 Dietary Supplement: Breakfast juice

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: The Effects of Nutritive and Non-nutritive Breakfast on Subjective Mental Workload During Multitasking - a Pilot Study in Healthy Volunteers

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Helsinki University:

Primary Outcome Measures:
  • Brain measures of mental workload (ERP 300 amplitude and latency) and heart rate [ Time Frame: 1 day ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Subjective mental workload and mood measurement assessed using visual analogue scale in response to test meal. [ Time Frame: 1 day ] [ Designated as safety issue: No ]
  • cognitive function measurements [ Time Frame: 1 day ] [ Designated as safety issue: No ]
  • Blood concentration of glucose [ Time Frame: 1 day ] [ Designated as safety issue: No ]
  • salivary cortisol [ Time Frame: 1 day ] [ Designated as safety issue: No ]
  • Blood concentration of tryptophan in relation to other large neutral amino acids [ Time Frame: 1 day ] [ Designated as safety issue: No ]

Enrollment: 13
Study Start Date: September 2011
Study Completion Date: March 2013
Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Dietary supplement: high-protein breakfast
high-protein juice
 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
Active Comparator: Dietary supplement: high-carbohydrate breakfast
high-carbohydrate juice
 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
Placebo Comparator: Dietary supplement: low energy breakfast
low-calorie juice
 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

  Eligibility

Ages Eligible for Study:   22 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01555385

Locations
Finland
University of Helsinki, Institute of Biomedicine
Helsinki, Finland, 00014
Sponsors and Collaborators
Helsinki University
Finnish Institute of Occupational Health
SalWe Ltd
  More Information

Additional Information:
Related Info  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Katri Peuhkuri, Principal investigator, postdoctoral reseacher, authorized nutritionist, Helsinki University
ClinicalTrials.gov Identifier: NCT01555385     History of Changes
Other Study ID Numbers: UH-SHOK-001
Study First Received: March 14, 2012
Last Updated: March 5, 2013
Health Authority: Finland: HUS ethics comittee

Keywords provided by Helsinki University:
Mental workload
Multitasking
Protein
Tryptophan

ClinicalTrials.gov processed this record on May 19, 2013