Investigation of How Morning Nutrition Influences Cognitive Performance

Not Applicable

Completed

• Conditions: Cognitive Performance
• Interventions: Other: Cereal with B glucan; Other: Cereal without B glucan

• Registration Number: NCT03169283
• Lead Sponsor: PepsiCo Global R&D

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-10
• Study First Submitted: 2014-11-05
• Primary Completion: 2015-04
• Study Completion: 2015-04
• Status Verified: 2017-05
• Study First Submitted QC: 2017-05-25
• Last Update Submitted: 2017-05-25
• Study First Posted: 2017-05-30
• Last Update Posted: 2017-05-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Cereal 1	Cereal with B glucan	A cereal high in viscous dietary fiber B glucan
Cereal 2	Cereal without B glucan	A cereal without B glucan

Primary Outcome Measures

Name	Time	Method
cognitive performance	0-4 hours	cognitive performance using psychometric scales

Secondary Outcome Measures

Name	Time	Method
subjective measures of hunger	0-4 hours	subjective measures of hunger using Visual Analog Scale

Trial Locations

Locations (1)

The Sheryl and Daniel R. Tishman Cognitive Neurophysiology Laboratory; 🇺🇸 The Bronx, New York, United States