Cognitive FunctionNCT03526406
Investigation of the Acute and Chronic Cognitive and Mood Effects of CP9700 in Humans
A study testing CP9700 in people with Cognitive Function and Mood, run by University of Reading at 1 site in United Kingdom.
Trial summary
This acute-on-chronic study will examine the effectiveness of CP9700 for improving cognitive performance and mood in healthy young adults. CP9700 is a mix of highly purified grape seed-derived polyphenolic extracts from Vitis vinifera produced by Polyphenolics Inc. (Madera, CA, USA). Read more about this study
- Who is it for?
- Ages 21 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Cognitive Function, Mood
- What is being tested?
- CP9700
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 20 Nov 2017to 28 Feb 2019
- 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 21 to 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Non Smoker
- Not Pregnant
- Non vegetarian or vegan
- Able to consume the capsules
Who cannot join
- Should not suffer from any of the following diseases: Major mental illness; Liver disease; Diabetes mellitus (Type 1 and 2); Heart disease; Renal or gastrointestinal disorders
- Should not be taking blood pressure lowering or anticoagulant medication
- Should not be taking depression medication
- Should not be consuming more than the Government recommended units of alcohol per week
- Should not be vigorous exercisers (restricted to < 4 hours per week for the duration of the study)
- Should not be taking nutritional supplements (for the duration of the study)
- Should not be taking recreational drugs (either illegal or legal for the duration of the study)
Trial locations and contacts
1 site in 1 country.
About this study
This acute-on-chronic study will examine the effectiveness of CP9700 for improving cognitive performance and mood in healthy young adults. CP9700 is a mix of highly purified grape seed-derived polyphenolic extracts from Vitis vinifera produced by Polyphenolics Inc. (Madera, CA, USA). The polyphenolic component of the product is comprised entirely of catechin and epicatechin, derivatives of catechin and epicatechin (e.g.,epicatechin gallate), and proanthocyanidins. We will perform a randomised, double-blind, parallel-groups human intervention trial using CP9700 and a well characterised sugar-matched placebo to investigate changes in cognitive performance.
Read the detailed description
Interventions: Two interventions will be tested, CP9700 (400 mg) and a placebo. Importantly, the placebo will be matched to the active treatment for sugars and vitamin C levels. All interventions will be supplied in blister packs.
Participants: A total of 60 healthy, young adult participants will be recruited for these studies. Based upon the medium effect size (d = .65) observed in previous work using healthy adults and the Go/No go task, we calculate that a sample of 25 participants/treatment will provide considerable power (.70) to detect a similar sized effect in this study. The recruitment procedure allows for a 15% drop out rate. Participants will be recruited directly from the School of Psychology \& Clinical Language Sciences Undergraduate Research Panel.
Procedure: Following recruitment to the study, participants will start a two-week 'run-in' phase. During this phase, all participants will complete a 3-day food frequency questionnaire to give a measure of their habitual diet before being asked to adhere to a low-flavonoid diet, we will collect a 3-day food diary to check compliance and they will attend the laboratory for an initial 'practice' session of the cognitive tasks (see below). On the evening before the 'active treatment' phase commences, participants will be asked to consume a standard meal- this procedure will be repeated for each evening meal consumed prior to a test day. On the acute test day, participants will attend the laboratory in a fasted state where they will receive a standard low-flavanoid breakfast, followed by a battery of cognitive and mood tasks (see below). Subjects will then be given their intervention, and will be re-tested on our task battery at two-hourly intervals over a 6 hour period before being allowed to return home. During the chronic phase of the study, after 6 and 12 weeks of consuming the intervention, subjects will return to the lab in a fasted state (prior to taking their daily intervention), will be given a standard low flavonoid breakfast, and will be tested on the task battery before consuming their allocated intervention. Compliance will be assured through collection of used blister packs.
The task battery is composed of cognitive tests and measures of mood, which our previous data show to be sensitive to flavonoid interventions, both acutely and chronically. More generally, the cognitive tests are categorised into one of two key cognitive domains; (i) Executive Function (i.e., Serial Sevens, Stroop, Modified Attention Network Test) and (ii) Episodic Memory (i.e., immediate and delayed auditory recall, verbal recognition, immediate and delayed spatial memory). Moreover, our previous data indicates increased cerebral blood flow in the in the acute postprandial phase 2-5 hours following flavonoid consumption in brain regions required for executive function and episodic memory including the frontal cortex and frontal gyrus. In addition, changes in mood will be measured using the PANAS, which has previously been shown to be sensitive to flavonoid interventions acutely and chronically.
- Conditions
- Cognitive Function, Mood
- Being tested
- CP9700, Matched Placebo
- Keywords
- Cognition, Mood, Flavonoid, Grape Seed, Catechin, Epicatechin, Proanthocyanidin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CP9700Dietary supplement
400 mg CP9700 along with modified cellulose (MCC), magnesioum strearate, slica (sillicon dioxide), Gelatin, FD\&C Red No. 40, titanium dioxide, sodium lauryl sulfate, glycerin, brilliant blue FCF consumed with breakfast in a 1 capsule per day regimen.
Matched PlaceboDietary supplement
Maltodextrin along with modified cellulose (MCC), magnesioum strearate, slica (sillicon dioxide), Gelatin, FD\&C Red No. 40, titanium dioxide, sodium lauryl sulfate, glycerin, brilliant blue FCF consumed with breakfast in a 1 capsule per day regimen.
| Study group | Role | What they receive |
|---|---|---|
| CP9700 | Experimental | 400 mg CP9700 along with modified cellulose (MCC), magnesium stearate, silica (sillicon dioxide), Gelatin, FD\&C Red No. 40, titanium dioxide, sodium lauryl sulfate, glycerin, brilliant blue FCF consumed with breakfast in a 1 capsule per day regimen. Receives: Dietary Supplement: CP9700 |
| Matched Placebo | Placebo comparator | Maltodextrin along with modified cellulose (MCC), magnesium stearate, silica (sillicon dioxide), Gelatin, FD\&C Red No. 40, titanium dioxide, sodium lauryl sulfate, glycerin, brilliant blue FCF consumed with breakfast in a 1 capsule per day regimen. Receives: Dietary Supplement: Matched Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cognitive Performance - Episodic Memory
As Measured by the Auditory Verbal Learning Task
Measured: 2 hrs following acute intervention.
Cognitive Performance - Episodic Memory
As Measured by the Auditory Verbal Learning Task
Measured: 4 hrs following acute intervention.
Cognitive Performance - Episodic Memory
As Measured by the Auditory Verbal Learning Task
Measured: 6 hrs following acute intervention.
Cognitive Performance - Episodic Memory
As Measured by the Auditory Verbal Learning Task
Measured: Following 6 weeks chronic intervention
Cognitive Performance - Episodic Memory
As Measured by the Auditory Verbal Learning Task
Measured: Following 12 weeks chronic intervention
Cognitive Performance - Attention shifting
As measured by the Switching Task
Measured: 2 hrs following acute intervention.
Cognitive Performance - Attention shifting
As measured by the Switching Task
Measured: 4 hrs following acute intervention.
Cognitive Performance - Attention shifting
As measured by the Switching Task
Measured: 6 hrs following acute intervention.
Cognitive Performance - Attention shifting
As measured by the Switching Task
Measured: Following 6 weeks chronic intervention
Cognitive Performance - Attention shifting
As measured by the Switching Task
Measured: Following 12 weeks chronic intervention
Cognitive Performance - Motor Control
As measured by the finger tapping task
Measured: 2 hrs following acute intervention.
Cognitive Performance - Motor Control
As measured by the finger tapping task
Measured: 4 hrs following acute intervention.
Cognitive Performance - Motor Control
As measured by the finger tapping task
Measured: 6 hrs following acute intervention.
Cognitive Performance - Motor Control
As measured by the finger tapping task
Measured: Following 6 weeks chronic intervention
Cognitive Performance - Motor Control
As measured by the finger tapping task
Measured: Following 12 weeks chronic intervention
Cognitive Performance - Working Memory
As measured by the serial 3 and 7s task
Measured: 2 hrs following acute intervention.
Cognitive Performance - Working Memory
As measured by the serial 3 and 7s task
Measured: 4 hrs following acute intervention.
Cognitive Performance - Working Memory
As measured by the serial 3 and 7s task
Measured: 6 hrs following acute intervention.
Cognitive Performance - Working Memory
As measured by the serial 3 and 7s task
Measured: Following 6 weeks chronic intervention
Cognitive Performance - Working Memory
As measured by the serial 3 and 7s task
Measured: Following 12 weeks chronic intervention
Cognitive Performance - Visual Memory Span
As measured by the Corsi Block Task
Measured: 2 hrs following acute intervention.
Cognitive Performance - Visual Memory Span
As measured by the Corsi Block Task
Measured: 4 hrs following acute intervention.
Cognitive Performance - Visual Memory Span
As measured by the Corsi Block Task
Measured: 6 hrs following acute intervention.
Cognitive Performance - Visual Memory Span
As measured by the Corsi Block Task
Measured: Following 6 weeks chronic intervention
Cognitive Performance - Visual Memory Span
As measured by the Corsi Block Task
Measured: Following 12 weeks chronic intervention
Secondary outcomes (5)
Mood
As measured by the Positive and Negative Affect Schedule
Measured: 2 hrs following acute intervention.
Mood
As measured by the Positive and Negative Affect Schedule
Measured: 4 hrs following acute intervention.
Mood
As measured by the Positive and Negative Affect Schedule
Measured: 6 hrs following acute intervention.
Mood
As measured by the Positive and Negative Affect Schedule
Measured: Following 6 weeks chronic intervention
Mood
As measured by the Positive and Negative Affect Schedule
Measured: Following 12 weeks chronic intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2018
- Study start20 Nov 2017
- Primary completion28 Feb 2019
- Study completion28 Feb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Cognitive FunctionStudies 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
- Parallel groups
- Model description
- Acute on chronic
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Reading
- Sponsor type
- University, hospital or other
- Collaborators
- Polyphenolics, Inc.
- Responsible party
- Principal investigator, Prof Claire Williams, University of Reading
- Investigators
- Claire M Williams, PhD, Principal investigator, University of Reading
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03526406
- Sponsor's protocol ID
- RDG-003
- Status last verified
- Aug 2020
- First submitted
- 14 Nov 2017
- Last updated
- 20 Aug 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Macready AL, Kennedy OB, Ellis JA, Williams CM, Spencer JP, Butler LT. Flavonoids and cognitive function: a review of human randomized controlled trial studies and recommendations for future studies. Genes Nutr. 2009 Dec;4(4):227-42. doi: 10.1007/s12263-009-0135-4. Epub 2009 Aug 13.
PubMed 19680703Bell L, Lamport DJ, Butler LT, Williams CM. A Review of the Cognitive Effects Observed in Humans Following Acute Supplementation with Flavonoids, and Their Associated Mechanisms of Action. Nutrients. 2015 Dec 9;7(12):10290-306. doi: 10.3390/nu7125538.
PubMed 26690214Lamport DJ, Dye L, Wightman JD, Lawton CL. A. The effects of flavonoid and other polyphenol consumption on cognitive performance: A systematic research review of human experimental and epidemiological studies. Nutrition and Aging. 1(1), 5-25, 2012
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Acute and Chronic Cognitive and Mood Effects of CP9700 in Humans
- ClinicalTrials.gov ID
- NCT03526406
- Acronym / sponsor ID
- RDG-003
- Conditions
- Cognitive Function, Mood
- Keywords
- Cognition, Mood, Flavonoid, Grape Seed, Catechin, Epicatechin, Proanthocyanidin
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University of ReadingUniversity, hospital or other
- Collaborators
- Polyphenolics, Inc.
- Study start
- 20 Nov 2017 (actual)
- Primary completion
- 28 Feb 2019 (actual)
- Study completion
- 28 Feb 2019 (actual)
- First posted
- 16 May 2018 (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 acute-on-chronic study will examine the effectiveness of CP9700 for improving cognitive performance and mood in healthy young adults. CP9700 is a mix of highly purified grape seed-derived polyphenolic extracts from Vitis vinifera produced by Polyphenolics Inc. (Madera, CA, USA). The polyphenolic component of the product is comprised entirely of catechin and epicatechin, derivatives of catechin and epicatechin (e.g.,epicatechin gallate), and proanthocyanidins. We will perform a randomised, double-blind, parallel-groups human intervention trial using CP9700 and a well characterised sugar-matched placebo to investigate changes in cognitive performance.
Detailed description
Interventions: Two interventions will be tested, CP9700 (400 mg) and a placebo. Importantly, the placebo will be matched to the active treatment for sugars and vitamin C levels. All interventions will be supplied in blister packs.
Participants: A total of 60 healthy, young adult participants will be recruited for these studies. Based upon the medium effect size (d = .65) observed in previous work using healthy adults and the Go/No go task, we calculate that a sample of 25 participants/treatment will provide considerable power (.70) to detect a similar sized effect in this study. The recruitment procedure allows for a 15% drop out rate. Participants will be recruited directly from the School of Psychology \& Clinical Language Sciences Undergraduate Research Panel.
Procedure: Following recruitment to the study, participants will start a two-week 'run-in' phase. During this phase, all participants will complete a 3-day food frequency questionnaire to give a measure of their habitual diet before being asked to adhere to a low-flavonoid diet, we will collect a 3-day food diary to check compliance and they will attend the laboratory for an initial 'practice' session of the cognitive tasks (see below). On the evening before the 'active treatment' phase commences, participants will be asked to consume a standard meal- this procedure will be repeated for each evening meal consumed prior to a test day. On the acute test day, participants will attend the laboratory in a fasted state where they will receive a standard low-flavanoid breakfast, followed by a battery of cognitive and mood tasks (see below). Subjects will then be given their intervention, and will be re-tested on our task battery at two-hourly intervals over a 6 hour period before being allowed to return home. During the chronic phase of the study, after 6 and 12 weeks of consuming the intervention, subjects will return to the lab in a fasted state (prior to taking their daily intervention), will be given a standard low flavonoid breakfast, and will be tested on the task battery before consuming their allocated intervention. Compliance will be assured through collection of used blister packs.
The task battery is composed of cognitive tests and measures of mood, which our previous data show to be sensitive to flavonoid interventions, both acutely and chronically. More generally, the cognitive tests are categorised into one of two key cognitive domains; (i) Executive Function (i.e., Serial Sevens, Stroop, Modified Attention Network Test) and (ii) Episodic Memory (i.e., immediate and delayed auditory recall, verbal recognition, immediate and delayed spatial memory). Moreover, our previous data indicates increased cerebral blood flow in the in the acute postprandial phase 2-5 hours following flavonoid consumption in brain regions required for executive function and episodic memory including the frontal cortex and frontal gyrus. In addition, changes in mood will be measured using the PANAS, which has previously been shown to be sensitive to flavonoid interventions acutely and chronically.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Acute on chronic
| Arm | Type | Receives |
|---|---|---|
| CP9700 | Experimental | Dietary Supplement: CP9700400 mg CP9700 along with modified cellulose (MCC), magnesium stearate, silica (sillicon dioxide), Gelatin, FD\&C Red No. 40, titanium dioxide, sodium lauryl sulfate, glycerin, brilliant blue FCF consumed with breakfast in a 1 capsule per day regimen. |
| Matched Placebo | Placebo comparator | Dietary Supplement: Matched PlaceboMaltodextrin along with modified cellulose (MCC), magnesium stearate, silica (sillicon dioxide), Gelatin, FD\&C Red No. 40, titanium dioxide, sodium lauryl sulfate, glycerin, brilliant blue FCF consumed with breakfast in a 1 capsule per day regimen. |
Who may qualify
- Ages
- 21 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Non Smoker
- Not Pregnant
- Non vegetarian or vegan
- Able to consume the capsules
Key exclusion criteria (7 listed)
- Should not suffer from any of the following diseases: Major mental illness; Liver disease; Diabetes mellitus (Type 1 and 2); Heart disease; Renal or gastrointestinal disorders
- Should not be taking blood pressure lowering or anticoagulant medication
- Should not be taking depression medication
- Should not be consuming more than the Government recommended units of alcohol per week
- Should not be vigorous exercisers (restricted to < 4 hours per week for the duration of the study)
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 |
|---|---|---|
| CP9700400 mg CP9700 along with modified cellulose (MCC), magnesioum strearate, slica (sillicon dioxide), Gelatin, FD\&C Red No. 40, titanium dioxide, sodium lauryl sulfate, glycerin, brilliant blue FCF consumed with breakfast in a 1 capsule per day regimen. | Dietary supplement | CP9700 |
| Matched PlaceboMaltodextrin along with modified cellulose (MCC), magnesioum strearate, slica (sillicon dioxide), Gelatin, FD\&C Red No. 40, titanium dioxide, sodium lauryl sulfate, glycerin, brilliant blue FCF consumed with breakfast in a 1 capsule per day regimen. | Dietary supplement | Matched Placebo |
Primary outcome
Cognitive Performance - Episodic Memory
Time frame: 2 hrs following acute intervention.
As Measured by the Auditory Verbal Learning Task
Cognitive Performance - Episodic Memory
Time frame: 4 hrs following acute intervention.
As Measured by the Auditory Verbal Learning Task
Cognitive Performance - Episodic Memory
Time frame: 6 hrs following acute intervention.
As Measured by the Auditory Verbal Learning Task
Cognitive Performance - Episodic Memory
Time frame: Following 6 weeks chronic intervention
As Measured by the Auditory Verbal Learning Task
Cognitive Performance - Episodic Memory
Time frame: Following 12 weeks chronic intervention
As Measured by the Auditory Verbal Learning Task
Cognitive Performance - Attention shifting
Time frame: 2 hrs following acute intervention.
As measured by the Switching Task
Cognitive Performance - Attention shifting
Time frame: 4 hrs following acute intervention.
As measured by the Switching Task
Cognitive Performance - Attention shifting
Time frame: 6 hrs following acute intervention.
As measured by the Switching Task
Cognitive Performance - Attention shifting
Time frame: Following 6 weeks chronic intervention
As measured by the Switching Task
Cognitive Performance - Attention shifting
Time frame: Following 12 weeks chronic intervention
As measured by the Switching Task
Cognitive Performance - Motor Control
Time frame: 2 hrs following acute intervention.
As measured by the finger tapping task
Cognitive Performance - Motor Control
Time frame: 4 hrs following acute intervention.
As measured by the finger tapping task
Cognitive Performance - Motor Control
Time frame: 6 hrs following acute intervention.
As measured by the finger tapping task
Cognitive Performance - Motor Control
Time frame: Following 6 weeks chronic intervention
As measured by the finger tapping task
Cognitive Performance - Motor Control
Time frame: Following 12 weeks chronic intervention
As measured by the finger tapping task
Cognitive Performance - Working Memory
Time frame: 2 hrs following acute intervention.
As measured by the serial 3 and 7s task
Cognitive Performance - Working Memory
Time frame: 4 hrs following acute intervention.
As measured by the serial 3 and 7s task
Cognitive Performance - Working Memory
Time frame: 6 hrs following acute intervention.
As measured by the serial 3 and 7s task
Cognitive Performance - Working Memory
Time frame: Following 6 weeks chronic intervention
As measured by the serial 3 and 7s task
Cognitive Performance - Working Memory
Time frame: Following 12 weeks chronic intervention
As measured by the serial 3 and 7s task
Cognitive Performance - Visual Memory Span
Time frame: 2 hrs following acute intervention.
As measured by the Corsi Block Task
Cognitive Performance - Visual Memory Span
Time frame: 4 hrs following acute intervention.
As measured by the Corsi Block Task
Cognitive Performance - Visual Memory Span
Time frame: 6 hrs following acute intervention.
As measured by the Corsi Block Task
Cognitive Performance - Visual Memory Span
Time frame: Following 6 weeks chronic intervention
As measured by the Corsi Block Task
Cognitive Performance - Visual Memory Span
Time frame: Following 12 weeks chronic intervention
As measured by the Corsi Block Task
5 secondary outcomes
Mood
Time frame: 2 hrs following acute intervention.
Mood
Time frame: 4 hrs following acute intervention.
Mood
Time frame: 6 hrs following acute intervention.
Mood
Time frame: Following 6 weeks chronic intervention
Mood
Time frame: Following 12 weeks chronic intervention
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 20 Aug 2020.
- Background: PubMed 19680703Macready AL, Kennedy OB, Ellis JA, Williams CM, Spencer JP, Butler LT. Flavonoids and cognitive function: a review of human randomized controlled trial studies and recommendations for future studies. Genes Nutr. 2009 Dec;4(4):227-42. doi: 10.1007/s12263-009-0135-4. Epub 2009 Aug 13.
- Background: PubMed 26690214Bell L, Lamport DJ, Butler LT, Williams CM. A Review of the Cognitive Effects Observed in Humans Following Acute Supplementation with Flavonoids, and Their Associated Mechanisms of Action. Nutrients. 2015 Dec 9;7(12):10290-306. doi: 10.3390/nu7125538.
- BackgroundLamport DJ, Dye L, Wightman JD, Lawton CL. A. The effects of flavonoid and other polyphenol consumption on cognitive performance: A systematic research review of human experimental and epidemiological studies. Nutrition and Aging. 1(1), 5-25, 2012
- 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.
Claire M Williams, PhD principal investigator
University of Reading
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CP9700 in people with Cognitive Function and Mood, run by University of Reading 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 7 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 20 Aug 2020. 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?
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 - Episodic Memory (time frame: 2 hrs following acute intervention.). The study lists 25 primary outcomes in all. 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 NCT03526406, which also lists 3 linked publications.
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 20 Aug 2020.