Investigation of How Morning Nutrition Influences Cognitive Performance

NCT ID: NCT03169283

Last Updated: 2017-05-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-10-31

Study Completion Date

2015-04-30

Brief Summary

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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

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Conditions

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Cognitive Performance

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Cereal 1

A cereal high in viscous dietary fiber B glucan

Group Type EXPERIMENTAL

Cereal with B glucan

Intervention Type OTHER

A cereal high in viscous dietary fiber B glucan

Cereal 2

A cereal without B glucan

Group Type ACTIVE_COMPARATOR

Cereal without B glucan

Intervention Type OTHER

Cereal without B glucan

Interventions

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Cereal with B glucan

A cereal high in viscous dietary fiber B glucan

Intervention Type OTHER

Cereal without B glucan

Cereal without B glucan

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

44 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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PepsiCo Global R&D

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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John Foxe, PhD

Role: PRINCIPAL_INVESTIGATOR

The Sheryl and Daniel R. Tishman Cognitive Neurophysiology Laboratory

Locations

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The Sheryl and Daniel R. Tishman Cognitive Neurophysiology Laboratory

The Bronx, New York, United States

Site Status

Countries

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United States

References

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Wilson TJ, Gray MJ, Van Klinken JW, Kaczmarczyk M, Foxe JJ. Macronutrient composition of a morning meal and the maintenance of attention throughout the morning. Nutr Neurosci. 2018 Dec;21(10):729-743. doi: 10.1080/1028415X.2017.1347998. Epub 2017 Jul 17.

Reference Type DERIVED
PMID: 28714768 (View on PubMed)

Other Identifiers

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PEP-1323

Identifier Type: -

Identifier Source: org_study_id

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