NCT03169283

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2014

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2014

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

November 5, 2014

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2015

Completed
2.2 years until next milestone

First Posted

Study publicly available on registry

May 30, 2017

Completed
Last Updated

May 30, 2017

Status Verified

May 1, 2017

Enrollment Period

6 months

First QC Date

November 5, 2014

Last Update Submit

May 25, 2017

Conditions

Cognitive Performance

Outcome Measures

Primary Outcomes (1)

  • cognitive performance

    cognitive performance using psychometric scales

    0-4 hours

Secondary Outcomes (1)

  • subjective measures of hunger

    0-4 hours

Study Arms (2)

Cereal 1

EXPERIMENTAL

A cereal high in viscous dietary fiber B glucan

Other: Cereal with B glucan

Cereal 2

ACTIVE COMPARATOR

A cereal without B glucan

Other: Cereal without B glucan

Interventions

Cereal with B glucanOTHER

A cereal high in viscous dietary fiber B glucan

Cereal 1
Cereal without B glucanOTHER

Cereal without B glucan

Cereal 2

Eligibility Criteria

Age18 Years - 44 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Sheryl and Daniel R. Tishman Cognitive Neurophysiology Laboratory

The Bronx, New York, 10461, United States

Location

Related Publications (1)

  • 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.

    PMID: 28714768DERIVED

MeSH Terms

Interventions

Edible Grain

Intervention Hierarchy (Ancestors)

Crops, AgriculturalFoodDiet, Food, and NutritionPhysiological PhenomenaSeedsFood and Beverages

Study Officials

  • John Foxe, PhD

    The Sheryl and Daniel R. Tishman Cognitive Neurophysiology Laboratory

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 5, 2014

First Posted

May 30, 2017

Study Start

October 1, 2014

Primary Completion

April 1, 2015

Study Completion

April 1, 2015

Last Updated

May 30, 2017

Record last verified: 2017-05

Locations

US(1)