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Completed

NCT Number: NCT03169283

Investigation of How Morning Nutrition Influences Cognitive Performance

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.

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Key information

Age range

18 year–44 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Sheryl and Daniel R. Tishman Cognitive Neurophysiology Laboratory

The Bronx, New York, 10461, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cereal with B glucan

Other

A cereal high in viscous dietary fiber B glucan

Cereal without B glucan

Other

Cereal without B glucan

Primary outcomes

  1. cognitive performance

    Time frame: 0-4 hours

    cognitive performance using psychometric scales

Secondary outcomes

  1. subjective measures of hunger

    Time frame: 0-4 hours

    subjective measures of hunger using Visual Analog Scale

Sponsors and collaborators

Lead sponsor

PepsiCo Global R&D

Industry

Registry information

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
May 30, 2017
Registry last updated
May 30, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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