EnergyNCT01625624
Evaluating the Effects of Food Products on Energy and Performance
A study testing Carbohydrate Food Bar and Modified Carbohydrate Food Bar in people with Energy, run by Mondelēz International, Inc. at 2 sites in United States.
Trial summary
The purpose of this study is to determine the effect of food products varying in composition, on energy in healthy adult subjects. Read more about this study
- Who is it for?
- Ages 20 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Energy
- What is being tested?
- Carbohydrate Food Bar and Modified Carbohydrate Food Bar
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- 2 sitesUnited States
- Study dates
- Jun 2012to Jun 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 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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).
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- 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).
Who cannot join
- 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.
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- 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).
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Renstar Medical Research
Ocala, Florida, 34471
Cognitive Research Corporation
St. Petersburg, Florida, 33701
About this study
Official title: Effect of Food Products on Perceived Energy and Task Performance
The purpose of this study is to determine the effect of food products varying in composition, on energy in healthy adult subjects.
- Conditions
- Energy
- Being tested
- Carbohydrate Food Bar, Modified Carbohydrate Food Bar
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Carbohydrate Food BarOther
Control Food Bar containing carbohydrate
Modified Carbohydrate Food BarOther
Test Food Bar containing modified carbohydrate
| Study group | Role | What they receive |
|---|---|---|
| Control Food Product | Placebo comparator | Not described Receives: Other: Carbohydrate Food Bar |
| Experimental Food Product | Experimental | Not described Receives: Other: Modified Carbohydrate Food Bar |
What is being measured
The primary outcome is the main question the study is designed to answer.
Subjective feeling of energy (visual analog scale)
Measured: 150 minutes post food consumption
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2012 (estimated)
- Study startJun 2012
- Primary completionJun 2012
- Study completionJun 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
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mondelēz International, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Cognitive Research Corporation
- Responsible party
- Sponsor
- Investigators
- Gary Kay, PhD, Principal investigator, Cognitive Research Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01625624
- Sponsor's protocol ID
- KFG-122X-02
- Status last verified
- May 2013
- First submitted
- 5 Jun 2012
- Last updated
- 9 May 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Food Products on Perceived Energy and Task Performance
- ClinicalTrials.gov ID
- NCT01625624
- Acronym / sponsor ID
- KFG-122X-02
- Conditions
- Energy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Mondelēz International, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Cognitive Research Corporation
- Study start
- Jun 2012
- Primary completion
- Jun 2012 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 21 Jun 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.
The purpose of this study is to determine the effect of food 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
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Food Product | Placebo comparator | Other: Carbohydrate Food Bar |
| Experimental Food Product | Experimental | Other: Modified Carbohydrate Food Bar |
Who may qualify
- Ages
- 20 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (12 listed)
- 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.
Key exclusion criteria (21 listed)
- 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.
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 |
|---|---|---|
| Carbohydrate Food BarControl Food Bar containing carbohydrate | Other | Control Food Product |
| Modified Carbohydrate Food BarTest Food Bar containing modified carbohydrate | Other | Experimental Food Product |
Primary outcome
Subjective feeling of energy (visual analog scale)
Time frame: 150 minutes post food consumption
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 9 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.
Gary Kay, PhD principal investigator
Cognitive Research Corporation
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Carbohydrate Food Bar and Modified Carbohydrate Food Bar in people with Energy, run by Mondelēz International, Inc. at 2 sites 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 21 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 9 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 2 sites 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?
Subjective feeling of energy (visual analog scale) (time frame: 150 minutes post food consumption). 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 9 May 2013.