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
  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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
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 October 19, 2014