Investigation of How Morning Nutrition Influences Cognitive Performance

Cognitive Performance Clinical Trial

Official title:

Investigation of How Morning Nutrition Influences Cognitive Performance

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03169283
• Other study ID #: PEP-1323
• Status: Completed
• Phase: N/A
• First received: November 5, 2014
• Last updated: May 25, 2017
• Start date: October 2014
• Est. completion date: April 2015

Study information

• Verified date: May 2017
• Source: PepsiCo Global R&D
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: April 2015
• Est. primary completion date: April 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 44 Years

Eligibility

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

Related Conditions & MeSH terms

• Cognitive Performance

Intervention

Other:
• Cereal with B glucan
A cereal high in viscous dietary fiber B glucan
• Cereal without B glucan
Cereal without B glucan

Locations

Country	Name	City	State
United States	The Sheryl and Daniel R. Tishman Cognitive Neurophysiology Laboratory	The Bronx	New York

Sponsors (1)

Lead Sponsor	Collaborator
PepsiCo Global R&D

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	cognitive performance	cognitive performance using psychometric scales	0-4 hours
Secondary	subjective measures of hunger	subjective measures of hunger using Visual Analog Scale	0-4 hours