Evaluating the Effects of Snack Products on Energy

Energy Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01544816
• Other study ID #: KFG-123X-01
• Status: Completed
• Phase: N/A
• First received: February 24, 2012
• Last updated: May 6, 2013
• Start date: February 2012
• Est. completion date: August 2012

Study information

• Verified date: May 2013
• Source: Mondelez International, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 49
• Est. completion date: August 2012
• Est. primary completion date: August 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 20 Years to 45 Years

Eligibility

Inclusion Criteria:

1. The subject must provide informed consent.

2. The subject is male or female, and between the ages of 20 and 45, inclusive.

3. The subject is a routine, moderate daily user of caffeine (approximately 1-4 cups of coffee or equivalent).

4. The subject is fluent in English.

5. The subject has a minimum of a high school diploma.

6. 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 .

7. The subject is in good physical and mental health based on a general medical history.

8. 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.

9. Must be able and willing to obtain a minimum of 7 hours of sleep the night prior to each study visit.

10. The subject is willing and able to comply with all requirements defined within this protocol.

11. The subject reports having a snack at least two afternoons per week.

12. The subject reports experiencing an "afternoon slump".

Exclusion Criteria

1. The subject has a 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.

2. Attention Deficit Disorder or Attention Deficit Hyperactivity Disorder

3. BMI = 19 or = 30 kg/m2.

4. The subject has documented allergies, adverse reactions, or intolerance to caffeine.

5. The subject has any significant medical illness or condition for which caffeine is contraindicated.

6. The subject has a history of drug dependence or substance use disorder based upon DSM-IV-TR criteria (excluding nicotine).

7. The subject has a positive urine drug or alcohol drug test result (to include nicotine).

8. The subject has participated in an investigational study or received an investigational drug within the past 28 days.

9. The subject has used nicotine products within 30 days of screening or during the duration of the study.

10. The subject is taking medications, that have CNS effects or affect performance, (such as sedating antihistamines and decongestant sympathomimetics, either oral or topical), and may interfere with efficacy or safety assessments.

11. The subject has a 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.

12. The female subject is pregnant or lactating or planning on becoming pregnant during the study

13. Hypertension or other chronic medical conditions

14. Individuals who do not maintain a routine nighttime sleep schedule (e.g. no shift work).

15. Individuals judged by the Investigator to be unsuitable for enrollment in this study for any reason.

16. The subject has been diagnosed with phenylketonuria.

17. Inability to perform performance tests within the Normal range (i.e., performance no lower than 1SD below the mean) at screening.

18. The subject has a pre-existing medical condition.

19. Subject has been diagnosed with a sleeping disorder.

20. Subject has a fasting glucose of >110 mg/dl.

21. Subject has an allergy to wheat, soy, nuts or other food.

22. Subject has Kosher or Halal dietary restrictions.

23. Subject reports never eating biscuits, cookies or crackers.

24. Epworth Sleepiness Scale = at screening (i.e., evidence of excessive daytime sleepiness).

25. Dislike of chocolate flavorings

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Energy

Intervention

Other:
• Snack Product
control food product
• Snack Product
Experimental food product containing ingredient 1
• Snack Product
Experimental food product containing ingredient 2

Locations

Country	Name	City	State
United States	Mercer University Center for Clinical Research	Atlanta	Georgia

Sponsors (3)

Lead Sponsor	Collaborator
Mondelez International, Inc.	Cognitive Research Corporation, Mercer University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Energy questionnaire OR Rating of perceived energy OR Subjective feeling of energy (visual analog scale)		90 minutes post snack	No