- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03169283
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
-
-
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
|
A cereal high in viscous dietary fiber B glucan
|
Active Comparator: Cereal 2
A 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
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.
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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