Evaluating the Effects of Snack Products on Energy

Mondelēz International, Inc.1 site in 1 country49 target enrollmentFebruary 2012

ConditionsEnergy

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Energy
Sponsor: Mondelēz International, Inc.
Enrollment: 49
Locations: 1
Primary Endpoint: Energy questionnaire OR Rating of perceived energy OR Subjective feeling of energy (visual analog scale)
Status: Completed
Last Updated: 12 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

To determine the effect of snack products varying in composition, on energy in healthy adult subjects.

Registry

clinicaltrials.gov

Start Date

February 2012

End Date

August 2012

Last Updated

12 years ago

Study Type

Interventional

Study Design

Crossover

Sex

All

Investigators

Sponsor

Mondelēz International, Inc.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•The subject must provide informed consent.
•The subject is male or female, and between the ages of 20 and 45, inclusive.
•The subject is a routine, moderate daily user of caffeine (approximately 1-4 cups of coffee or equivalent).
•The subject is fluent in English.
•The subject has a minimum of a high school diploma.
•Females of Child-bearing Potential (FOCP) must have a negative urine or serum beta HCG pregnancy test at screening. FOCP must abstain from sexual activity that could result in a pregnancy, or use acceptable contraceptives throughout the period of study treatment exposure. Acceptable contraceptives include IUDs, hormonal contraceptives (oral, implanted or injectable) and double barrier methods (such as condom or diaphragm with spermicidal gel). If hormonal contraceptives are used, the period of use must be sufficiently long to achieve pharmacological effectiveness prior to study treatment exposure (refer to individual product information for details on onset of effectiveness). FOCP who are not currently sexually active, must agree to use acceptable contraception, as defined above, if they decide to become sexually active during the period of study treatment exposure .
•The subject is in good physical and mental health based on a general medical history.
•The subject has adequate visual and auditory acuity and cognitive ability to complete the assessments and is capable of understanding and following instructions for the performance tests within the normal, age-adjusted range (within one SD) at screening.
•Must be able and willing to obtain a minimum of 7 hours of sleep the night prior to each study visit.
•The subject is willing and able to comply with all requirements defined within this protocol.