Evaluating the Effects of Food Products on Energy and Performance
Effect of Food Products on Perceived Energy and Task Performance
Study Overview
Status
Status
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
Study Type
Study Type
Enrollment (Actual)
Enrollment
Phase
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Florida
-
Ocala, Florida, United States, 34471
- Renstar Medical Research
-
Saint Petersburg, Florida, United States, 33701
- Cognitive Research Corporation
-
-
Participation Criteria
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Age 20-35 years (inclusive).
- English as primary language.
- Have a minimum of a high school degree (note that GED is not sufficient).
- 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 and for 30 days after the last study treatment. 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 and for thirty days thereafter.
- Good physical and mental health based on a general medical, mental health questionnaire.
- Adequate visual, auditory and cognitive ability to complete the assessments within the Normal range (i.e., no more than 1 standard deviation below the mean for the subject's age and years of education).
- Willing and able to comply with all requirements defined within this protocol.
- Willing to obtain at least 7 hours of nighttime sleep during the evenings prior to study visits.
- Willing to avoid strenuous exercise for 24 hours prior to visits.
- Willing to avoid alcohol for 24 hours prior to visits.
- Willing to abstain from caffeine after midnight prior to visits.
- Moderate daily user of caffeine (approximately 1-4 cups of coffee or equivalent per day).
Exclusion Criteria:
- Current Axis I or Axis II comorbid psychiatric diagnosis or other symptomatic manifestations that, in the opinion of the examining physician (Investigator), will contraindicate treatment with caffeine.
- Attention Deficit Hyperactivity Disorder.
- BMI ≤ 19 or ≥ 30 kg/m2.
- History of drug dependence or substance use disorder based upon DSM-IV-TR criteria (excluding nicotine).
- Positive urine drug or alcohol drug test result.
- Users of nicotine products within 30 days of screening or during the duration of the study.
- Taking any over the counter or prescription medications other than birth control.
- Concurrent chronic or acute illness (such as allergic rhinitis or severe cold), disability, or other condition that might confound the results of rating tests administered in the study or that might increase risk to the subject. Similarly, the subject will be excluded if he or she has any additional conditions that, in the Investigator's opinion, would preclude the subject from completing the study or would not be in the best interest of the subject. This would include any significant illness or unstable medical condition that could lead to difficulty complying with the protocol.
- Participation in an investigational study or received an investigational drug within the past 28 days.
- Individuals who do not maintain a routine nighttime sleep schedule (no shift work).
- Pregnant or lactating women, or women planning to become pregnant during the study.
- Hypertension or other chronic medical conditions.
- Judged by the Investigator to be unsuitable for enrollment in this study for any reason.
- Has been diagnosed with phenylketonuria.
- Individuals with sleep disorders (e.g. sleep apnea, primary or secondary insomnia).
- Known pre-existing medical condition.
- Has a fasting glucose of >110 mg/dl.
- Has an allergy to wheat, soy, nuts or any other food.
- Has Kosher or Halal dietary restrictions.
- Reports never eating biscuits, cookies or crackers.
- Epworth Sleepiness Scale ≥ 12 at screening (i.e., evidence of excessive daytime sleepiness).
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Double
Number of Arms
Arms and Interventions
Participant Group / ArmParticipant Group / Arm |
Intervention / TreatmentIntervention / Treatment |
|---|---|
|
Placebo Comparator: Control Food Product
|
Control Food Bar containing carbohydrate
|
|
Experimental: Experimental Food Product
|
Test Food Bar containing modified carbohydrate
|
What is the study measuring?
Primary Outcome Measures
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Subjective feeling of energy (visual analog scale)
Time Frame: 150 minutes post food consumption
|
150 minutes post food consumption
|
Collaborators and Investigators
Sponsor
Sponsor
Collaborators
Collaborators
Investigators
Investigators
- Principal Investigator: Gary Kay, PhD, Cognitive Research Corporation
Study record dates
Study Major Dates
Study Start
Study Start
Primary Completion (Actual)
Primary Completion
Study Completion (Actual)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (Estimate)
First Posted
Study Record Updates
Last Update Posted (Estimate)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
Other Study ID Numbers
- KFG-122X-02
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