Cognitive PerformanceNCT03169283
Investigation of How Morning Nutrition Influences Cognitive Performance
A study testing Cereal with B glucan and Cereal without B glucan in people with Cognitive Performance, run by PepsiCo Global R&D at 1 site in United States.
Trial summary
This project will assess the effects of the macro-nutrient make-up of morning food intake on cognitive performance using visual analog scale (VAS) measures, behavioral tests, and advanced high-density electrophysiological techniques (256-channel recordings). Read more about this study
- Who is it for?
- Ages 18 to 44 yearsHealthy volunteers can take part
- Conditions the study is for
- Cognitive Performance
- What is being tested?
- Cereal with B glucan and Cereal without B glucan
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2014to Apr 2015
- 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 18 to 44 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy and taking no regular medications other than birth control or hormone replacement therapy
- Willing to use an effective contraceptive during the study, if sexually active and capable of bearing children
- Willing and able to sign informed consent
- Normal or corrected-to-normal vision
- Normal or corrected-to-normal hearing
- No history of neurological or psychiatric illness, including major depressive disorder and attention deficit disorder
- No history of substance, nicotine or alcohol dependence
- BMI below 35
Who cannot join
- Women who are pregnant or nursing
- Gain or loss of > 4kg in the last 3 months.
- Currently taking supplements or medications for weight loss
- Currently taking medications for neurological or psychiatric illness
- Diabetes mellitus (fasting glucose >126 mg/dL) or history of diabetes
- Dietary restraint on the Three Factor Eating Questionnaire score greater than or equal to 14
Show all 10Show fewer
- Allergy to any of the foods used for the test breakfasts (oats or milk)
- History of GI disorders or GI surgical procedures for weight loss
- History of eating disorders
- Daily consumption of more than 400 mg of caffeine
Trial locations and contacts
1 site in 1 country.
United States1 site
The Sheryl and Daniel R. Tishman Cognitive Neurophysiology Laboratory
The Bronx, New York, 10461
About this study
This project will assess the effects of the macro-nutrient make-up of morning food intake on cognitive performance using visual analog scale (VAS) measures, behavioral tests, and advanced high-density electrophysiological techniques (256-channel recordings). Two Isocaloric cereal products will be tested and compared to determine if measures of cognitive performance as well as satiety will change after consumption.
- Conditions
- Cognitive Performance
- Being tested
- Cereal with B glucan, Cereal without B glucan
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cereal with B glucanOther
A cereal high in viscous dietary fiber B glucan
Cereal without B glucanOther
Cereal without B glucan
| Study group | Role | What they receive |
|---|---|---|
| Cereal 1 | Experimental | A cereal high in viscous dietary fiber B glucan Receives: Other: Cereal with B glucan |
| Cereal 2 | Active comparator | A cereal without B glucan Receives: Other: Cereal without B glucan |
What is being measured
The primary outcome is the main question the study is designed to answer.
cognitive performance
cognitive performance using psychometric scales
Measured: 0-4 hours
Secondary outcomes (1)
subjective measures of hunger
subjective measures of hunger using Visual Analog Scale
Measured: 0-4 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2017
- Study startOct 2014
- Primary completionApr 2015
- Study completionApr 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cognitive PerformanceStudies 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
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- PepsiCo Global R&D
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- John Foxe, PhD, Principal investigator, The Sheryl and Daniel R. Tishman Cognitive Neurophysiology Laboratory
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03169283
- Sponsor's protocol ID
- PEP-1323
- Status last verified
- May 2017
- First submitted
- 5 Nov 2014
- Last updated
- 30 May 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Wilson TJ, Gray MJ, Van Klinken JW, Kaczmarczyk M, Foxe JJ. Macronutrient composition of a morning meal and the maintenance of attention throughout the morning. Nutr Neurosci. 2018 Dec;21(10):729-743. doi: 10.1080/1028415X.2017.1347998. Epub 2017 Jul 17.
PubMed 28714768
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of How Morning Nutrition Influences Cognitive Performance
- ClinicalTrials.gov ID
- NCT03169283
- Acronym / sponsor ID
- PEP-1323
- Conditions
- Cognitive Performance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- PepsiCo Global R&DIndustry (pharma, biotech, devices)
- Study start
- Oct 2014 (actual)
- Primary completion
- Apr 2015 (actual)
- Study completion
- Apr 2015 (actual)
- First posted
- 30 May 2017 (actual)
- 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.
This project will assess the effects of the macro-nutrient make-up of morning food intake on cognitive performance using visual analog scale (VAS) measures, behavioral tests, and advanced high-density electrophysiological techniques (256-channel recordings). Two Isocaloric cereal products will be tested and compared to determine if measures of cognitive performance as well as satiety will change after consumption.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cereal 1 | Experimental | Other: Cereal with B glucanA cereal high in viscous dietary fiber B glucan |
| Cereal 2 | Active comparator | Other: Cereal without B glucanA cereal without B glucan |
Who may qualify
- Ages
- 18 to 44 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Healthy and taking no regular medications other than birth control or hormone replacement therapy
- Willing to use an effective contraceptive during the study, if sexually active and capable of bearing children
- Willing and able to sign informed consent
- Normal or corrected-to-normal vision
- Normal or corrected-to-normal hearing
Key exclusion criteria (10 listed)
- Women who are pregnant or nursing
- Gain or loss of > 4kg in the last 3 months.
- Currently taking supplements or medications for weight loss
- Currently taking medications for neurological or psychiatric illness
- Diabetes mellitus (fasting glucose >126 mg/dL) or history of diabetes
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 |
|---|---|---|
| Cereal with B glucanA cereal high in viscous dietary fiber B glucan | Other | Cereal 1 |
| Cereal without B glucanCereal without B glucan | Other | Cereal 2 |
Primary outcome
cognitive performance
Time frame: 0-4 hours
cognitive performance using psychometric scales
1 secondary outcome
subjective measures of hunger
Time frame: 0-4 hours
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 30 May 2017.
- Derived from this study: PubMed 28714768Wilson TJ, Gray MJ, Van Klinken JW, Kaczmarczyk M, Foxe JJ. Macronutrient composition of a morning meal and the maintenance of attention throughout the morning. Nutr Neurosci. 2018 Dec;21(10):729-743. doi: 10.1080/1028415X.2017.1347998. Epub 2017 Jul 17.
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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.
John Foxe, PhD principal investigator
The Sheryl and Daniel R. Tishman Cognitive Neurophysiology Laboratory
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cereal with B glucan and Cereal without B glucan in people with Cognitive Performance, run by PepsiCo Global R&D 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 8 inclusion and 10 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 30 May 2017. 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. 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?
cognitive performance (time frame: 0-4 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03169283, which also lists 1 linked publication.
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 30 May 2017.