Change in Cognitive Function and Fatigue During Extended Performance of the Cognitive Demand Battery (CDB) at 1, 3 and 6 Hours Post ConsumptionCEOPTBNCT02202629
Plant Based Extracts and Cognition
A study testing Beverage containing plant based extracts in people with Change in Cognitive Function and Fatigue During Extended Performance of the Cognitive Demand Battery (CDB) at 1, 3 and 6 Hours Post Consumption and Change in Long Term Declarative Memory at 1, 3 and 6 Hours Post-intervention., run by PepsiCo Global R&D at 1 site in United Kingdom.
Trial summary
Acute, randomized, placebo controlled, double blind, 4 arm crossover study to determine the effect of different combinations of plant based extracts on cognitive function and cerebral blood flow. Read more about this study
- Who is it for?
- Ages 18 to 49 yearsHealthy volunteers can take part
- Conditions the study is for
- Change in Cognitive Function and Fatigue During Extended Performance of the Cognitive Demand Battery (CDB) at 1, 3 and 6 Hours Post Consumption, Change in Long Term Declarative Memory at 1, 3 and 6 Hours Post-intervention.
- What is being tested?
- Beverage containing plant based extracts
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jul 2014to Dec 2014
- 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 49 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Are over 18 or under 49 years of age
- Self-report of good health
- Are not excluded on the basis of the following exclusion criteria
- English is first language (some of the cognitive tests have only been validated in native English speakers)
Who cannot join
- Are below 18 or above 49 years of age
- Are a smoker
- Have food allergies or sensitivities to any of the ingredients contained in the investigational product or any other foodstuff
- Currently take medication except the contraceptive pill
- Have habitually used dietary supplements within the last month (defined as more than 3 consecutive days or 4 days in total)
- Have sleep disturbances and/or are taking sleep aid medication
Show all 24Show fewer
- Have a Body Mass Index (BMI) outside of the range 18-35 kg/m2
- Have high blood pressure (systolic over 139 mm Hg or diastolic over 89 mm Hg)
- Have a history of neurological, vascular or psychiatric illness including epilepsy or seizures (excluding depressive illness and anxiety)
- Have a current diagnosis of anxiety or depression
- Are pregnant, trying to get pregnant or breast feeding
- Have a recent history of (within 12 months of screening visit) or strong potential for alcohol or substance abuse. Alcohol abuse is defined as more than 60g (men) / 40g (women) pure alcohol per day (7 / 5.5 units)
- Are (or are seeking to become) pregnant or are lactating
- Have learning difficulties, dyslexia or colour blindness
- Have visual impairment that cannot be corrected with glasses or contact lenses
- Have frequent migraines that require medication (more than or equal to 1 per month)
- Have disorders of the blood
- Have a heart disorder or a history of vascular illness
- Have a respiratory disorder that requires regular medication (Note: participants with asthma who only take their medication occasionally/as required are eligible for this study)
- Have type I or type II diabetes
- Have a history of renal or hepatic disease, or other severe diseases of the gastrointestinal tract (e.g. iron accumulation, iron utilization disorders, hypercalcaemia, hypercalciuria), that are likely to interfere with metabolism/absorption/secretion of the product under investigation
- Have any health condition that would prevent fulfillment of the study requirements
- Are currently or have in the past 4 weeks participated in other clinical or nutrition intervention studies
- Do not have a bank account (required for payment)
Trial locations and contacts
1 site in 1 country.
David Kennedy, PhD contact
Philippa Jackson contact
United Kingdom1 site
Northumbria University
Newcastle upon Tyne, NE1 8ST
About this study
Official title: The Effects of Different Combinations of Plant Based Extracts on Cognitive Function and Cerebral Blood Flow in Humans
Acute, randomized, placebo controlled, double blind, 4 arm crossover study to determine the effect of different combinations of plant based extracts on cognitive function and cerebral blood flow.
Read the detailed description
The objectives of this study are to assess the effects of oral consumption of three differing combinations of plant based extracts, on cognitive function and cerebral blood flow (using Near infrared Spectroscopy) in comparison to placebo. The primary outcome will be change in cognitive function and mental fatigue during extended performance of the Cognitive Demand Battery (CDB) at 1, 3 and 6 hours post- consumption.
- Conditions
- Change in Cognitive Function and Fatigue During Extended Performance of the Cognitive Demand Battery (CDB) at 1, 3 and 6 Hours Post Consumption, Change in Long Term Declarative Memory at 1, 3 and 6 Hours Post-intervention.
- Being tested
- Beverage containing plant based extracts
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Beverage containing plant based extractsOther
Intervention involves single exposure, oral consumption of test article following baseline measurements
| Study group | Role | What they receive |
|---|---|---|
| Cherry flavoured beverage 1 | Placebo comparator | 10floz cherry flavoured test article |
| Cherry flavoured beverage 2 | Experimental | 10floz of cherry flavoured test article with fruit, vegetable and herbal extracts Receives: Other: Beverage containing plant based extracts |
| Cherry flavoured beverage 3 | Experimental | 10floz of cherry flavoured test article with fruit, vegetable and herbal extracts Receives: Other: Beverage containing plant based extracts |
| Cherry flavoured beverage 4 | Experimental | 10floz of cherry flavoured test article with fruit, vegetable and herbal extracts Receives: Other: Beverage containing plant based extracts |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in cognitive function and fatigue during extended performance of the Cognitive Demand Battery (CDB) at 1, 3 and 6 hours post consumption Change in long term declarative memory at 1, 3 and 6 hours post-intervention.
Measured: 1-6 hours post intervention
Secondary outcomes (4)
Change in executive function at 1, 3 and 6 hours post intervention.
Measured: 1-6 hours post intervention
Change in cerebral blood flow parameters (oxygenated and deoxygenated haemoglobin levels and their sum) in the frontal cortex during task performance commencing at 1, 3 and 6 hours post-intervention.
Measured: 1-6 hours post intervention
Change in episodic memory, as measured by immediate word recall, at 1, 3 and 6 hours post intervention.
Measured: 1-6 hours post intervention
Change in mood ratings, at 1,3 and 6 hours post intervention.
Measured: 1-6 hours post intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2014 (estimated)
- Study startJul 2014
- Primary completionDec 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Change in Cognitive Function and Fatigue During Extended Performance of the Cognitive Demand Battery (CDB) at 1, 3 and 6 Hours Post ConsumptionStudies 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
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- PepsiCo Global R&D
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02202629
- Sponsor's protocol ID
- PEP-1406
- Acronym
- CEOPTB
- Status last verified
- Jul 2014
- First submitted
- 24 Jul 2014
- Last updated
- 29 Jul 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Different Combinations of Plant Based Extracts on Cognitive Function and Cerebral Blood Flow in Humans
- ClinicalTrials.gov ID
- NCT02202629
- Acronym / sponsor ID
- CEOPTB / PEP-1406
- Conditions
- Change in Cognitive Function and Fatigue During Extended Performance of the Cognitive Demand Battery (CDB) at 1, 3 and 6 Hours Post Consumption, Change in Long Term Declarative Memory at 1, 3 and 6 Hours Post-intervention.
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- PepsiCo Global R&DIndustry (pharma, biotech, devices)
- Study start
- Jul 2014
- Primary completion
- Dec 2014 (estimated)
- First posted
- 29 Jul 2014 (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.
Acute, randomized, placebo controlled, double blind, 4 arm crossover study to determine the effect of different combinations of plant based extracts on cognitive function and cerebral blood flow.
Detailed description
The objectives of this study are to assess the effects of oral consumption of three differing combinations of plant based extracts, on cognitive function and cerebral blood flow (using Near infrared Spectroscopy) in comparison to placebo. The primary outcome will be change in cognitive function and mental fatigue during extended performance of the Cognitive Demand Battery (CDB) at 1, 3 and 6 hours post- consumption.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Cherry flavoured beverage 1 | Placebo comparator | –10floz cherry flavoured test article |
| Cherry flavoured beverage 2 | Experimental | Other: Beverage containing plant based extracts10floz of cherry flavoured test article with fruit, vegetable and herbal extracts |
| Cherry flavoured beverage 3 | Experimental | Other: Beverage containing plant based extracts10floz of cherry flavoured test article with fruit, vegetable and herbal extracts |
| Cherry flavoured beverage 4 | Experimental | Other: Beverage containing plant based extracts10floz of cherry flavoured test article with fruit, vegetable and herbal extracts |
Who may qualify
- Ages
- 18 to 49 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Are over 18 or under 49 years of age
- Self-report of good health
- Are not excluded on the basis of the following exclusion criteria
- English is first language (some of the cognitive tests have only been validated in native English speakers)
Key exclusion criteria (24 listed)
- Are below 18 or above 49 years of age
- Are a smoker
- Have food allergies or sensitivities to any of the ingredients contained in the investigational product or any other foodstuff
- Currently take medication except the contraceptive pill
- Have habitually used dietary supplements within the last month (defined as more than 3 consecutive days or 4 days in total)
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 |
|---|---|---|
| Beverage containing plant based extractsIntervention involves single exposure, oral consumption of test article following baseline measurements | Other | Cherry flavoured beverage 2, Cherry flavoured beverage 3, Cherry flavoured beverage 4 |
Primary outcome
Change in cognitive function and fatigue during extended performance of the Cognitive Demand Battery (CDB) at 1, 3 and 6 hours post consumption Change in long term declarative memory at 1, 3 and 6 hours post-intervention.
Time frame: 1-6 hours post intervention
4 secondary outcomes
Change in executive function at 1, 3 and 6 hours post intervention.
Time frame: 1-6 hours post intervention
Change in cerebral blood flow parameters (oxygenated and deoxygenated haemoglobin levels and their sum) in the frontal cortex during task performance commencing at 1, 3 and 6 hours post-intervention.
Time frame: 1-6 hours post intervention
Change in episodic memory, as measured by immediate word recall, at 1, 3 and 6 hours post intervention.
Time frame: 1-6 hours post intervention
Change in mood ratings, at 1,3 and 6 hours post intervention.
Time frame: 1-6 hours post intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2014.
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.
David Kennedy, PhD contact
Philippa Jackson contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Beverage containing plant based extracts in people with Change in Cognitive Function and Fatigue During Extended Performance of the Cognitive Demand Battery (CDB) at 1, 3 and 6 Hours Post Consumption and Change in Long Term Declarative Memory at 1, 3 and 6 Hours Post-intervention., run by PepsiCo Global R&D at 1 site in United Kingdom.
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 4 inclusion and 24 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: status not confirmed, as of the sponsor's last update on 29 Jul 2014. 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 Kingdom. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact David Kennedy, PhD (david.kennedy@northumbria.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in cognitive function and fatigue during extended performance of the Cognitive Demand Battery (CDB) at 1, 3 and 6 hours post consumption Change in long term declarative memory at 1, 3 and 6 hours post-intervention. (time frame: 1-6 hours post intervention). 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 29 Jul 2014.