- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03526406
Investigation of the Acute and Chronic Cognitive and Mood Effects of CP9700 in Humans
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Berkshire
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Reading, Berkshire, United Kingdom, RG6 6AL
- University of Reading
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Non Smoker
- Not Pregnant
- Non vegetarian or vegan
- Able to consume the capsules
Exclusion Criteria:
- 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)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: CP9700
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.
|
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.
|
Placebo Comparator: Matched Placebo
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Cognitive Performance - Episodic Memory
Time Frame: 2 hrs following acute intervention.
|
As Measured by the Auditory Verbal Learning Task
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2 hrs following acute intervention.
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Cognitive Performance - Episodic Memory
Time Frame: 4 hrs following acute intervention.
|
As Measured by the Auditory Verbal Learning Task
|
4 hrs following acute intervention.
|
Cognitive Performance - Episodic Memory
Time Frame: 6 hrs following acute intervention.
|
As Measured by the Auditory Verbal Learning Task
|
6 hrs following acute intervention.
|
Cognitive Performance - Episodic Memory
Time Frame: Following 6 weeks chronic intervention
|
As Measured by the Auditory Verbal Learning Task
|
Following 6 weeks chronic intervention
|
Cognitive Performance - Episodic Memory
Time Frame: Following 12 weeks chronic intervention
|
As Measured by the Auditory Verbal Learning Task
|
Following 12 weeks chronic intervention
|
Cognitive Performance - Attention shifting
Time Frame: 2 hrs following acute intervention.
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As measured by the Switching Task
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2 hrs following acute intervention.
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Cognitive Performance - Attention shifting
Time Frame: 4 hrs following acute intervention.
|
As measured by the Switching Task
|
4 hrs following acute intervention.
|
Cognitive Performance - Attention shifting
Time Frame: 6 hrs following acute intervention.
|
As measured by the Switching Task
|
6 hrs following acute intervention.
|
Cognitive Performance - Attention shifting
Time Frame: Following 6 weeks chronic intervention
|
As measured by the Switching Task
|
Following 6 weeks chronic intervention
|
Cognitive Performance - Attention shifting
Time Frame: Following 12 weeks chronic intervention
|
As measured by the Switching Task
|
Following 12 weeks chronic intervention
|
Cognitive Performance - Motor Control
Time Frame: 2 hrs following acute intervention.
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As measured by the finger tapping task
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2 hrs following acute intervention.
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Cognitive Performance - Motor Control
Time Frame: 4 hrs following acute intervention.
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As measured by the finger tapping task
|
4 hrs following acute intervention.
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Cognitive Performance - Motor Control
Time Frame: 6 hrs following acute intervention.
|
As measured by the finger tapping task
|
6 hrs following acute intervention.
|
Cognitive Performance - Motor Control
Time Frame: Following 6 weeks chronic intervention
|
As measured by the finger tapping task
|
Following 6 weeks chronic intervention
|
Cognitive Performance - Motor Control
Time Frame: Following 12 weeks chronic intervention
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As measured by the finger tapping task
|
Following 12 weeks chronic intervention
|
Cognitive Performance - Working Memory
Time Frame: 2 hrs following acute intervention.
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As measured by the serial 3 and 7s task
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2 hrs following acute intervention.
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Cognitive Performance - Working Memory
Time Frame: 4 hrs following acute intervention.
|
As measured by the serial 3 and 7s task
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4 hrs following acute intervention.
|
Cognitive Performance - Working Memory
Time Frame: 6 hrs following acute intervention.
|
As measured by the serial 3 and 7s task
|
6 hrs following acute intervention.
|
Cognitive Performance - Working Memory
Time Frame: Following 6 weeks chronic intervention
|
As measured by the serial 3 and 7s task
|
Following 6 weeks chronic intervention
|
Cognitive Performance - Working Memory
Time Frame: Following 12 weeks chronic intervention
|
As measured by the serial 3 and 7s task
|
Following 12 weeks chronic intervention
|
Cognitive Performance - Visual Memory Span
Time Frame: 2 hrs following acute intervention.
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As measured by the Corsi Block Task
|
2 hrs following acute intervention.
|
Cognitive Performance - Visual Memory Span
Time Frame: 4 hrs following acute intervention.
|
As measured by the Corsi Block Task
|
4 hrs following acute intervention.
|
Cognitive Performance - Visual Memory Span
Time Frame: 6 hrs following acute intervention.
|
As measured by the Corsi Block Task
|
6 hrs following acute intervention.
|
Cognitive Performance - Visual Memory Span
Time Frame: Following 6 weeks chronic intervention
|
As measured by the Corsi Block Task
|
Following 6 weeks chronic intervention
|
Cognitive Performance - Visual Memory Span
Time Frame: Following 12 weeks chronic intervention
|
As measured by the Corsi Block Task
|
Following 12 weeks chronic intervention
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Mood
Time Frame: 2 hrs following acute intervention.
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As measured by the Positive and Negative Affect Schedule
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2 hrs following acute intervention.
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Mood
Time Frame: 4 hrs following acute intervention.
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As measured by the Positive and Negative Affect Schedule
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4 hrs following acute intervention.
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Mood
Time Frame: 6 hrs following acute intervention.
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As measured by the Positive and Negative Affect Schedule
|
6 hrs following acute intervention.
|
Mood
Time Frame: Following 6 weeks chronic intervention
|
As measured by the Positive and Negative Affect Schedule
|
Following 6 weeks chronic intervention
|
Mood
Time Frame: Following 12 weeks chronic intervention
|
As measured by the Positive and Negative Affect Schedule
|
Following 12 weeks chronic intervention
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Claire M Williams, PhD, University of Reading
Publications and helpful links
General 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.
- Bell 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.
- Lamport 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 record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- RDG-003
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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