EnergyNCT01544816
Evaluating the Effects of Snack Products on Energy
A study testing Snack Product in people with Energy, run by Mondelēz International, Inc. at 1 site in United States.
Trial summary
To determine the effect of snack products varying in composition, on energy in healthy adult subjects. Read more about this study
- Who is it for?
- Ages 20 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Energy
- What is being tested?
- Snack Product
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 49 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2012to Aug 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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 .
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- 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.
- The subject reports having a snack at least two afternoons per week.
- The subject reports experiencing an "afternoon slump".
Who cannot join
- 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.
- Attention Deficit Disorder or Attention Deficit Hyperactivity Disorder
- BMI ≤ 19 or ≥ 30 kg/m2.
- The subject has documented allergies, adverse reactions, or intolerance to caffeine.
- The subject has any significant medical illness or condition for which caffeine is contraindicated.
- The subject has a history of drug dependence or substance use disorder based upon DSM-IV-TR criteria (excluding nicotine).
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- The subject has a positive urine drug or alcohol drug test result (to include nicotine).
- The subject has participated in an investigational study or received an investigational drug within the past 28 days.
- The subject has used nicotine products within 30 days of screening or during the duration of the study.
- 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.
- 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.
- The female subject is pregnant or lactating or planning on becoming pregnant during the study
- Hypertension or other chronic medical conditions
- Individuals who do not maintain a routine nighttime sleep schedule (e.g. no shift work).
- Individuals judged by the Investigator to be unsuitable for enrollment in this study for any reason.
- The subject has been diagnosed with phenylketonuria.
- Inability to perform performance tests within the Normal range (i.e., performance no lower than 1SD below the mean) at screening.
- The subject has a pre-existing medical condition.
- Subject has been diagnosed with a sleeping disorder.
- Subject has a fasting glucose of >110 mg/dl.
- Subject has an allergy to wheat, soy, nuts or other food.
- Subject has Kosher or Halal dietary restrictions.
- Subject reports never eating biscuits, cookies or crackers.
- Epworth Sleepiness Scale ≥ at screening (i.e., evidence of excessive daytime sleepiness).
- Dislike of chocolate flavorings
Trial locations and contacts
1 site in 1 country.
United States1 site
Mercer University Center for Clinical Research
Atlanta, Georgia, 30341
About this study
To determine the effect of snack products varying in composition, on energy in healthy adult subjects.
- Conditions
- Energy
- Being tested
- Snack Product
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Snack ProductOther
control food product
Snack ProductOther
Experimental food product containing ingredient 1
Snack ProductOther
Experimental food product containing ingredient 2
| Study group | Role | What they receive |
|---|---|---|
| Control Food Product | Placebo comparator | Control food product Receives: Other: Snack Product |
| Experimental Food Product 1 | Experimental | Experimental food product 1 Receives: Other: Snack Product |
| Experimental Food Product 2 | Experimental | Experimental food product 2 Receives: Other: Snack Product |
What is being measured
The primary outcome is the main question the study is designed to answer.
Energy questionnaire OR Rating of perceived energy OR Subjective feeling of energy (visual analog scale)
Measured: 90 minutes post snack
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2012 (estimated)
- Study startFeb 2012
- Primary completionAug 2012
- Study completionAug 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EnergyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mondelēz International, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Cognitive Research Corporation, Mercer University
- Responsible party
- Sponsor
- Investigators
- Chad VanDenBerg, Pharm.D., Principal investigator, Mercer University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01544816
- Sponsor's protocol ID
- KFG-123X-01
- Status last verified
- May 2013
- First submitted
- 24 Feb 2012
- Last updated
- 8 May 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Effects of Snack Products on Energy
- ClinicalTrials.gov ID
- NCT01544816
- Acronym / sponsor ID
- KFG-123X-01
- Conditions
- Energy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- Mondelēz International, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Cognitive Research Corporation, Mercer University
- Study start
- Feb 2012
- Primary completion
- Aug 2012 (actual)
- Study completion
- Aug 2012 (actual)
- First posted
- 6 Mar 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To determine the effect of snack products varying in composition, on energy in healthy adult subjects.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control Food Product | Placebo comparator | Other: Snack ProductControl food product |
| Experimental Food Product 1 | Experimental | Other: Snack ProductExperimental food product 1 |
| Experimental Food Product 2 | Experimental | Other: Snack ProductExperimental food product 2 |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (12 listed)
- 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.
Key exclusion criteria (25 listed)
- 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.
- Attention Deficit Disorder or Attention Deficit Hyperactivity Disorder
- BMI ≤ 19 or ≥ 30 kg/m2.
- The subject has documented allergies, adverse reactions, or intolerance to caffeine.
- The subject has any significant medical illness or condition for which caffeine is contraindicated.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Snack Productcontrol food product | Other | Control Food Product |
| Snack ProductExperimental food product containing ingredient 1 | Other | Experimental Food Product 1 |
| Snack ProductExperimental food product containing ingredient 2 | Other | Experimental Food Product 2 |
Primary outcome
Energy questionnaire OR Rating of perceived energy OR Subjective feeling of energy (visual analog scale)
Time frame: 90 minutes post snack
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chad VanDenBerg, Pharm.D. principal investigator
Mercer University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Snack Product in people with Energy, run by Mondelēz International, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 May 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Energy questionnaire OR Rating of perceived energy OR Subjective feeling of energy (visual analog scale) (time frame: 90 minutes post snack). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2013.