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Clinical Trials/NCT03169283
NCT03169283
Completed
Not Applicable

Investigation of How Morning Nutrition Influences Cognitive Performance

PepsiCo Global R&D1 site in 1 country24 target enrollmentOctober 2014

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Cognitive Performance
Sponsor
PepsiCo Global R&D
Enrollment
24
Locations
1
Primary Endpoint
cognitive performance
Status
Completed
Last Updated
8 years ago

Overview

Brief Summary

This project will assess the effects of the macro-nutrient make-up of morning food intake on cognitive performance using visual analog scale (VAS) measures, behavioral tests, and advanced high-density electrophysiological techniques (256-channel recordings). Two Isocaloric cereal products will be tested and compared to determine if measures of cognitive performance as well as satiety will change after consumption.

Registry
clinicaltrials.gov
Start Date
October 2014
End Date
April 2015
Last Updated
8 years ago
Study Type
Interventional
Study Design
Crossover
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Healthy and taking no regular medications other than birth control or hormone replacement therapy
  • Willing to use an effective contraceptive during the study, if sexually active and capable of bearing children
  • Willing and able to sign informed consent
  • Normal or corrected-to-normal vision
  • Normal or corrected-to-normal hearing
  • No history of neurological or psychiatric illness, including major depressive disorder and attention deficit disorder
  • No history of substance, nicotine or alcohol dependence
  • BMI below 35

Exclusion Criteria

  • Women who are pregnant or nursing
  • Gain or loss of \> 4kg in the last 3 months.
  • Currently taking supplements or medications for weight loss
  • Currently taking medications for neurological or psychiatric illness
  • Diabetes mellitus (fasting glucose \>126 mg/dL) or history of diabetes
  • Dietary restraint on the Three Factor Eating Questionnaire score greater than or equal to 14
  • Allergy to any of the foods used for the test breakfasts (oats or milk)
  • History of GI disorders or GI surgical procedures for weight loss
  • History of eating disorders
  • Daily consumption of more than 400 mg of caffeine

Outcomes

Primary Outcomes

cognitive performance

Time Frame: 0-4 hours

cognitive performance using psychometric scales

Secondary Outcomes

  • subjective measures of hunger(0-4 hours)

Study Sites (1)

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