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Investigation of How Morning Nutrition Influences Cognitive Performance

PepsiCo logo

PepsiCo

Status

Completed

Conditions

Cognitive Performance

Treatments

Other: Cereal with B glucan
Other: Cereal without B glucan

Study type

Interventional

Funder types

Industry

Identifiers

NCT03169283
PEP-1323

Details and patient eligibility

About

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.

Enrollment

24 patients

Sex

All

Ages

18 to 44 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Basic Science

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

None (Open label)

24 participants in 2 patient groups

Cereal 1
Experimental group
Description:
A cereal high in viscous dietary fiber B glucan
Treatment:
Other: Cereal with B glucan
Cereal 2
Active Comparator group
Description:
A cereal without B glucan
Treatment:
Other: Cereal without B glucan

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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