Investigation of How Morning Nutrition Influences Cognitive Performance

May 25, 2017 updated by: PepsiCo Global R&D
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

24

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • The Bronx, New York, United States, 10461
        • The Sheryl and Daniel R. Tishman Cognitive Neurophysiology Laboratory

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 44 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Cereal 1
A cereal high in viscous dietary fiber B glucan
Other: Cereal with B glucan
A cereal high in viscous dietary fiber B glucan
Active Comparator: Cereal 2
A cereal without B glucan
Other: Cereal without B glucan
Cereal without B glucan

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
cognitive performance
Time Frame: 0-4 hours
cognitive performance using psychometric scales
0-4 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
subjective measures of hunger
Time Frame: 0-4 hours
subjective measures of hunger using Visual Analog Scale
0-4 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

PepsiCo Global R&D

Investigators

  • Principal Investigator: John Foxe, PhD, The Sheryl and Daniel R. Tishman Cognitive Neurophysiology Laboratory

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2014

Primary Completion (Actual)

April 1, 2015

Study Completion (Actual)

April 1, 2015

Study Registration Dates

First Submitted

November 5, 2014

First Submitted That Met QC Criteria

May 25, 2017

First Posted (Actual)

May 30, 2017

Study Record Updates

Last Update Posted (Actual)

May 30, 2017

Last Update Submitted That Met QC Criteria

May 25, 2017

Last Verified

May 1, 2017

More Information

Terms related to this study

Other Study ID Numbers

  • PEP-1323

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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