Mental ProcessesPhase 1POM-03NCT02935777
Acute Effect of Pomegranate Extract on Cognitive Function
A Phase 1 study testing Pomegranate Extract in people with Mental Processes, run by Angela Stockton at 1 site in United Kingdom.
Trial summary
The double-blinded, randomised, placebo-controlled crossover pilot study is conducted as a two week intervention after a pre-intervention registration and preparation period. This study explores whether acute supplementation with pomegranate extract can modulate indicators of cognitive function and mood in healthy… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Mental Processes
- What is being tested?
- Pomegranate Extract
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Apr 2014to Sep 2014
- Phase
- Phase 1
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy
- Aged 18-65
- Enjoy computer tasks
Who cannot join
- Diagnosis with any neurological, psychiatric or significant medical condition which could affect cognitive function
- Known cognitive impairment
- Use of any prescription, herbal or recreational drugs
- Gastrointestinal disease
- Pregnancy or breastfeeding
- Pomegranate allergy
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Queen Margaret University
Edinburgh, Scotland, EH21 6UU
About this study
Official title: Investigation of the Acute Effect of Pomegranate Extract on Cognitive Function in Human Volunteers: A Double-blind, Placebo-controlled, Crossover Trial
The double-blinded, randomised, placebo-controlled crossover pilot study is conducted as a two week intervention after a pre-intervention registration and preparation period.
This study explores whether acute supplementation with pomegranate extract can modulate indicators of cognitive function and mood in healthy adults. Changes in physiological and biochemical markers are also investigated.
Read the detailed description
Participants are asked to visit the QMU clinical lab three times. The first visit is for general information, form completion, measurements and consent plus a practise session on COMPASS, the study computer software. Information and consent forms and a screening questionnaire are completed. Basic information such as age, sex, weight, height and blood pressure data are recorded. Lab visits 2 and 3, which are a week apart, constitute the intervention phase.
Participants are randomly assigned to either the pomegranate extract (PE) or placebo group.The researcher and participants are blinded to which capsules they are taking until data collection is complete. The randomisation process is carried out by independent technical staff who use an internet random number generator site to allocate treatment. The PE and placebo capsules look identical and are placed in sealed, labeled, pre-prepared opaque containers numbered by technicians.
At the next lab session (visit 2) participants begin their randomised study arm, taking either two pomegranate extract or two placebo capsules with water by mouth. Participants repeat the procedure at visit 3, where they crossover to the remaining intervention. Thus if participant A consumed placebo capsules at visit 2, the participant would take pomegranate extract capsules at visit 3, following a washout period of a week. If participant B consumed pomegranate extract on visit 2, the participant would then take the placebo capsules at visit 3.
At each visit, participants complete two computer testing sessions lasting approximately 45 minutes - one pre and one post capsule ingestion. After the capsule is taken there is a one hour absorption period before the next computer test session begins.
Participants are fasted from tea and coffee overnight and abstain for the period of the intervention in the morning. On the day before the tests, they are requested to refrain from alcohol, recreational drugs, and vigorous exercise.
Participants are also required to restrict herbal extracts, food supplements and polyphenols such as dark chocolate, fruit rich in polyphenols and antioxidants to less than three portions for 24 hrs beforehand. A 24 hour pre test food diary is completed to assist in compliance. Participants are also advised to have a good night's sleep - at least 6-8 h during the night before the study day - and should not be more stressed than usual. These aspects are confirmed before participants are allowed to commence their sessions.
Pre-study saliva collection is completed at home by participants early in the morning. This provides a biochemical marker which aims to support both cognitive findings and the results from the Bond Lader mood questionnaire completed during the computer testing. Instructions are given to participants for saliva collection and the samples analysed for cortisol and cortisone. Participants are instructed to have their usual breakfast except for coffee or tea. Blood pressure is taken pre and post study on visits 2 and 3.
The baseline computerised cognitive test battery is administered in the clinic at 9am lasting around 45 mins. The investigator then observes the participants consuming their scheduled capsules. After a one hour quiet absorption period around 11am, blood pressure is taken again. The post cognitive testing battery is completed once more and then a second post study saliva collection is taken. Participants complete the intervention around 12 noon. All assessments are carried out on a QMU computer, with the same laptop used by each participant at baseline and post intervention assessments.
The cognitive testing is conducted under controlled laboratory conditions with the assessments at baseline and post study always performed at the same time of day (between 0830 and 1200) for each participant.
Participant responses to the cognitive tests are recorded automatically by the computer software during the testing battery at visits 2 and 3.
- Conditions
- Mental Processes
- Being tested
- Pomegranate Extract, Placebo capsule
- Keywords
- Pomegranate extract, cognitive function, cognition, polyphenols, memory
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pomegranate ExtractDietary supplement
Also called POMANOX
The first computer cognitive testing session lasting approximately 45 minutes is undertaken by participants. After completion, intervention capsules are administered. After a 60 minute absorption period, the cognitive testing session is re-administered.
Placebo capsuleDietary supplement
One computer cognitive testing session lasting approximately 45 minutes is undertaken by participants. After completion, placebo capsules are administered. After a 60 minute absorption period, the cognitive testing session is re-administered.
| Study group | Role | What they receive |
|---|---|---|
| Pomegranate Extract | Experimental | POMANOX® pomegranate extract capsules with water by mouth, once. Dosage: 2 capsules
Capsules weigh1.083g and contain: 210mg punicalagin, 328mg other pomegranate polyphenols (e.g. flavonoids and ellagic acid), 0.37mg anthocyanins and maltodextrin. Receives: Dietary Supplement: Pomegranate Extract |
| Placebo | Placebo comparator | Identical placebo capsules by mouth, administered once. Dosage 2 capsules. Each capsule contains maltodextrin to provide PE capsule energy equivalent i.e.6.52 kcal or 27.28kJ. Receives: Dietary Supplement: Placebo capsule |
What is being measured
The primary outcome is the main question the study is designed to answer.
Simple reaction time (attention and vigilance, speed of attention)
Reaction time in msec.
Measured: 1-2 hours
Choice reaction time (attention and vigilance, speed and accuracy of attention)
Arrows pointing left and right will appear on the screen at irregular intervals. The participant is required to indicate the direction of the arrow as quickly as possible, whenever an arrow is displayed. Measured by % accuracy, overall correct responses and reaction time (ms).
Measured: 1-2 hours
Bond Lader mood scales
Mood is measured via the Bond Lader series of mood scales, each scored out of 100. From these scales three composite scores are calculated describing feelings of 'Alert', 'Calm' and 'Content', also presented as a score out of 100.
Measured: 1-2 hours
Digit vigilance (attention and vigilance, speed and accuracy of attention)
A fixed number will appear on the right of the screen and a series of changing numbers will appear on the left side of the screen. Participants are required to make a response when the number on the left matches the number on the right. Measured by reaction time (ms) and %accuracy of responses.
Measured: 1-2 hours
Word presentation (secondary memory) then delayed Word recall (quality of memory)
A list of words is displayed on the screen, one word at a time. Participants are given 60 seconds to write down as many of the words they were shown earlier as they can. This task was performed following following a delay between the presentation and recall (delayed recall). no of correct responses and % accuracy.
Measured: 1-2 hours
Word recognition (secondary memory, quality and speed of memory)
All target words that were shown during Word Presentation plus an equal number of decoys will be displayed on the screen one at a time. Participants indicate if they remember seeing the word earlier or not. measured by correct no of responses, errors and reaction time (ms).
Measured: 1-2 hours
Rapid Visual Information Processing (RVIP) (cognitive demand)
A series of numbers are displayed individually on the screen in quick succession (at a rate of 100 numbers per minute) and participants are required to respond when they see 3 odd numbers in a row or three even numbers in a row. Measured by % accuracy, no of false alarms and reaction time (ms).
Measured: 1-2 hours
Picture presentation (secondary memory) and delayed recognition(secondary memory, speed and quality of memory)
A series of pictures are displayed on the screen, one at a time. After a delay, all target pictures shown during Picture Presentation plus an equal number of decoys will be displayed on the screen one at a time. For each stimulus participants select 'Yes' or 'No' to indicate if they have seen the picture before or not. The task is measured by reaction time (ms), % accuracy and no of correct responses.
Measured: 1-2 hours
Corsi blocks lite (working memory, spatial memory)
Blue squares on a black background are displayed on the screen. Some of them change to red and back to blue again in a sequence. Participants are required to remember this sequence. The task is repeated five times at each level of difficulty with the sequence span increasing from 4 upwards, until the participant can no longer correctly recall the sequences. The task continues up to 6 squares in each sequence, while participants make enough correct responses. As soon as they make less than 3 correct responses (out of the five in one level) the task will end. All participants complete levels 4-6 regardless of incorrect responses. Results are measured by a span score: This score is calculated as the average of the last 3 correctly completed trials. For example, if the participant correctly responds to all five Level 4 trials and only one Level 5 trial, their span score would be 4.3 [(4 + 4 + 5)/3].
Measured: 1-2 hours
Secondary outcomes (2)
Pre and post blood pressure changes
Measurement of systolic and diastolic blood pressure in mmHg.
Measured: 1-2 hours
Pre-post cortisol and cortisone changes
Collection of saliva which is processed via ELISA to measure cortisol and cortisone in ng/mL
Measured: 3-4 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2016 (estimated)
- Study startApr 2014
- Primary completionJul 2014
- Study completionSep 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mental ProcessesStudies 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 1
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Angela Stockton
- Sponsor type
- University, hospital or other
- Collaborators
- Northumbria University
- Responsible party
- Sponsor-investigator, Angela Stockton, Queen Margaret University
- Investigators
- Emad Aldujaili, Study director, Dean of Pharmacy, Jordan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02935777
- Sponsor's protocol ID
- POM-03
- Acronym
- POM-03
- Status last verified
- Oct 2016
- First submitted
- 6 Oct 2016
- Last updated
- 18 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Acute Effect of Pomegranate Extract on Cognitive Function in Human Volunteers: A Double-blind, Placebo-controlled, Crossover Trial
- ClinicalTrials.gov ID
- NCT02935777
- Acronym / sponsor ID
- POM-03 / POM-03
- Conditions
- Mental Processes
- Keywords
- Pomegranate extract, cognitive function, cognition, polyphenols, memory
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Angela StocktonUniversity, hospital or other
- Collaborators
- Northumbria University
- Study start
- Apr 2014
- Primary completion
- Jul 2014 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 18 Oct 2016 (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 double-blinded, randomised, placebo-controlled crossover pilot study is conducted as a two week intervention after a pre-intervention registration and preparation period.
This study explores whether acute supplementation with pomegranate extract can modulate indicators of cognitive function and mood in healthy adults. Changes in physiological and biochemical markers are also investigated.
Detailed description
Participants are asked to visit the QMU clinical lab three times. The first visit is for general information, form completion, measurements and consent plus a practise session on COMPASS, the study computer software. Information and consent forms and a screening questionnaire are completed. Basic information such as age, sex, weight, height and blood pressure data are recorded. Lab visits 2 and 3, which are a week apart, constitute the intervention phase.
Participants are randomly assigned to either the pomegranate extract (PE) or placebo group.The researcher and participants are blinded to which capsules they are taking until data collection is complete. The randomisation process is carried out by independent technical staff who use an internet random number generator site to allocate treatment. The PE and placebo capsules look identical and are placed in sealed, labeled, pre-prepared opaque containers numbered by technicians.
At the next lab session (visit 2) participants begin their randomised study arm, taking either two pomegranate extract or two placebo capsules with water by mouth. Participants repeat the procedure at visit 3, where they crossover to the remaining intervention. Thus if participant A consumed placebo capsules at visit 2, the participant would take pomegranate extract capsules at visit 3, following a washout period of a week. If participant B consumed pomegranate extract on visit 2, the participant would then take the placebo capsules at visit 3.
At each visit, participants complete two computer testing sessions lasting approximately 45 minutes - one pre and one post capsule ingestion. After the capsule is taken there is a one hour absorption period before the next computer test session begins.
Participants are fasted from tea and coffee overnight and abstain for the period of the intervention in the morning. On the day before the tests, they are requested to refrain from alcohol, recreational drugs, and vigorous exercise.
Participants are also required to restrict herbal extracts, food supplements and polyphenols such as dark chocolate, fruit rich in polyphenols and antioxidants to less than three portions for 24 hrs beforehand. A 24 hour pre test food diary is completed to assist in compliance. Participants are also advised to have a good night's sleep - at least 6-8 h during the night before the study day - and should not be more stressed than usual. These aspects are confirmed before participants are allowed to commence their sessions.
Pre-study saliva collection is completed at home by participants early in the morning. This provides a biochemical marker which aims to support both cognitive findings and the results from the Bond Lader mood questionnaire completed during the computer testing. Instructions are given to participants for saliva collection and the samples analysed for cortisol and cortisone. Participants are instructed to have their usual breakfast except for coffee or tea. Blood pressure is taken pre and post study on visits 2 and 3.
The baseline computerised cognitive test battery is administered in the clinic at 9am lasting around 45 mins. The investigator then observes the participants consuming their scheduled capsules. After a one hour quiet absorption period around 11am, blood pressure is taken again. The post cognitive testing battery is completed once more and then a second post study saliva collection is taken. Participants complete the intervention around 12 noon. All assessments are carried out on a QMU computer, with the same laptop used by each participant at baseline and post intervention assessments.
The cognitive testing is conducted under controlled laboratory conditions with the assessments at baseline and post study always performed at the same time of day (between 0830 and 1200) for each participant.
Participant responses to the cognitive tests are recorded automatically by the computer software during the testing battery at visits 2 and 3.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pomegranate Extract | Experimental | Dietary Supplement: Pomegranate ExtractPOMANOX® pomegranate extract capsules with water by mouth, once. Dosage: 2 capsules Capsules weigh1.083g and contain: 210mg punicalagin, 328mg other pomegranate polyphenols (e.g. flavonoids and ellagic acid), 0.37mg anthocyanins and maltodextrin. |
| Placebo | Placebo comparator | Dietary Supplement: Placebo capsuleIdentical placebo capsules by mouth, administered once. Dosage 2 capsules. Each capsule contains maltodextrin to provide PE capsule energy equivalent i.e.6.52 kcal or 27.28kJ. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Healthy
- Aged 18-65
- Enjoy computer tasks
Key exclusion criteria (6 listed)
- Diagnosis with any neurological, psychiatric or significant medical condition which could affect cognitive function
- Known cognitive impairment
- Use of any prescription, herbal or recreational drugs
- Gastrointestinal disease
- Pregnancy or breastfeeding
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 |
|---|---|---|
| Pomegranate ExtractAlso: POMANOXThe first computer cognitive testing session lasting approximately 45 minutes is undertaken by participants. After completion, intervention capsules are administered. After a 60 minute absorption period, the cognitive testing session is re-administered. | Dietary supplement | Pomegranate Extract |
| Placebo capsuleOne computer cognitive testing session lasting approximately 45 minutes is undertaken by participants. After completion, placebo capsules are administered. After a 60 minute absorption period, the cognitive testing session is re-administered. | Dietary supplement | Placebo |
Primary outcome
Simple reaction time (attention and vigilance, speed of attention)
Time frame: 1-2 hours
Reaction time in msec.
Choice reaction time (attention and vigilance, speed and accuracy of attention)
Time frame: 1-2 hours
Arrows pointing left and right will appear on the screen at irregular intervals. The participant is required to indicate the direction of the arrow as quickly as possible, whenever an arrow is displayed. Measured by % accuracy, overall correct responses and reaction time (ms).
Bond Lader mood scales
Time frame: 1-2 hours
Mood is measured via the Bond Lader series of mood scales, each scored out of 100. From these scales three composite scores are calculated describing feelings of 'Alert', 'Calm' and 'Content', also presented as a score out of 100.
Digit vigilance (attention and vigilance, speed and accuracy of attention)
Time frame: 1-2 hours
A fixed number will appear on the right of the screen and a series of changing numbers will appear on the left side of the screen. Participants are required to make a response when the number on the left matches the number on the right. Measured by reaction time (ms) and %accuracy of responses.
Word presentation (secondary memory) then delayed Word recall (quality of memory)
Time frame: 1-2 hours
A list of words is displayed on the screen, one word at a time. Participants are given 60 seconds to write down as many of the words they were shown earlier as they can. This task was performed following following a delay between the presentation and recall (delayed recall). no of correct responses and % accuracy.
Word recognition (secondary memory, quality and speed of memory)
Time frame: 1-2 hours
All target words that were shown during Word Presentation plus an equal number of decoys will be displayed on the screen one at a time. Participants indicate if they remember seeing the word earlier or not. measured by correct no of responses, errors and reaction time (ms).
Rapid Visual Information Processing (RVIP) (cognitive demand)
Time frame: 1-2 hours
A series of numbers are displayed individually on the screen in quick succession (at a rate of 100 numbers per minute) and participants are required to respond when they see 3 odd numbers in a row or three even numbers in a row. Measured by % accuracy, no of false alarms and reaction time (ms).
Picture presentation (secondary memory) and delayed recognition(secondary memory, speed and quality of memory)
Time frame: 1-2 hours
A series of pictures are displayed on the screen, one at a time. After a delay, all target pictures shown during Picture Presentation plus an equal number of decoys will be displayed on the screen one at a time. For each stimulus participants select 'Yes' or 'No' to indicate if they have seen the picture before or not. The task is measured by reaction time (ms), % accuracy and no of correct responses.
Corsi blocks lite (working memory, spatial memory)
Time frame: 1-2 hours
Blue squares on a black background are displayed on the screen. Some of them change to red and back to blue again in a sequence. Participants are required to remember this sequence. The task is repeated five times at each level of difficulty with the sequence span increasing from 4 upwards, until the participant can no longer correctly recall the sequences. The task continues up to 6 squares in each sequence, while participants make enough correct responses. As soon as they make less than 3 correct responses (out of the five in one level) the task will end. All participants complete levels 4-6 regardless of incorrect responses. Results are measured by a span score: This score is calculated as the average of the last 3 correctly completed trials. For example, if the participant correctly responds to all five Level 4 trials and only one Level 5 trial, their span score would be 4.3 [(4 + 4 + 5)/3].
2 secondary outcomes
Pre and post blood pressure changes
Time frame: 1-2 hours
Pre-post cortisol and cortisone changes
Time frame: 3-4 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 18 Oct 2016.
- Individual participant dataSharing planned: No
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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.
Emad Aldujaili study director
Dean of Pharmacy, Jordan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Pomegranate Extract in people with Mental Processes, run by Angela Stockton 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 3 inclusion and 6 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 18 Oct 2016. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Simple reaction time (attention and vigilance, speed of attention) (time frame: 1-2 hours). The study lists 9 primary outcomes in all. 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 18 Oct 2016.