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Trial record 11 of 49 for:    Sodium Lauryl Sulfate

Investigation of the Acute and Chronic Cognitive and Mood Effects of CP9700 in Humans

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ClinicalTrials.gov Identifier: NCT03526406
Recruitment Status : Active, not recruiting
First Posted : May 16, 2018
Last Update Posted : July 4, 2018
Sponsor:
Collaborator:
Polyphenolics, Inc.
Information provided by (Responsible Party):
Prof Claire Williams, University of Reading

Brief 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). 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.

Condition or disease Intervention/treatment Phase
Cognitive Function Mood Dietary Supplement: CP9700 Dietary Supplement: Matched Placebo Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Acute on chronic
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Investigation of the Acute and Chronic Cognitive and Mood Effects of CP9700 in Humans
Actual Study Start Date : November 20, 2017
Estimated Primary Completion Date : September 2018
Estimated Study Completion Date : September 2018

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.
Dietary Supplement: CP9700
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.
Dietary Supplement: Matched Placebo
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.




Primary Outcome Measures :
  1. Cognitive Performance - Episodic Memory [ Time Frame: 2 hrs following acute intervention. ]
    As Measured by the Auditory Verbal Learning Task

  2. Cognitive Performance - Episodic Memory [ Time Frame: 4 hrs following acute intervention. ]
    As Measured by the Auditory Verbal Learning Task

  3. Cognitive Performance - Episodic Memory [ Time Frame: 6 hrs following acute intervention. ]
    As Measured by the Auditory Verbal Learning Task

  4. Cognitive Performance - Episodic Memory [ Time Frame: Following 6 weeks chronic intervention ]
    As Measured by the Auditory Verbal Learning Task

  5. Cognitive Performance - Episodic Memory [ Time Frame: Following 12 weeks chronic intervention ]
    As Measured by the Auditory Verbal Learning Task

  6. Cognitive Performance - Attention shifting [ Time Frame: 2 hrs following acute intervention. ]
    As measured by the Switching Task

  7. Cognitive Performance - Attention shifting [ Time Frame: 4 hrs following acute intervention. ]
    As measured by the Switching Task

  8. Cognitive Performance - Attention shifting [ Time Frame: 6 hrs following acute intervention. ]
    As measured by the Switching Task

  9. Cognitive Performance - Attention shifting [ Time Frame: Following 6 weeks chronic intervention ]
    As measured by the Switching Task

  10. Cognitive Performance - Attention shifting [ Time Frame: Following 12 weeks chronic intervention ]
    As measured by the Switching Task

  11. Cognitive Performance - Motor Control [ Time Frame: 2 hrs following acute intervention. ]
    As measured by the finger tapping task

  12. Cognitive Performance - Motor Control [ Time Frame: 4 hrs following acute intervention. ]
    As measured by the finger tapping task

  13. Cognitive Performance - Motor Control [ Time Frame: 6 hrs following acute intervention. ]
    As measured by the finger tapping task

  14. Cognitive Performance - Motor Control [ Time Frame: Following 6 weeks chronic intervention ]
    As measured by the finger tapping task

  15. Cognitive Performance - Motor Control [ Time Frame: Following 12 weeks chronic intervention ]
    As measured by the finger tapping task

  16. Cognitive Performance - Working Memory [ Time Frame: 2 hrs following acute intervention. ]
    As measured by the serial 3 and 7s task

  17. Cognitive Performance - Working Memory [ Time Frame: 4 hrs following acute intervention. ]
    As measured by the serial 3 and 7s task

  18. Cognitive Performance - Working Memory [ Time Frame: 6 hrs following acute intervention. ]
    As measured by the serial 3 and 7s task

  19. Cognitive Performance - Working Memory [ Time Frame: Following 6 weeks chronic intervention ]
    As measured by the serial 3 and 7s task

  20. Cognitive Performance - Working Memory [ Time Frame: Following 12 weeks chronic intervention ]
    As measured by the serial 3 and 7s task

  21. Cognitive Performance - Visual Memory Span [ Time Frame: 2 hrs following acute intervention. ]
    As measured by the Corsi Block Task

  22. Cognitive Performance - Visual Memory Span [ Time Frame: 4 hrs following acute intervention. ]
    As measured by the Corsi Block Task

  23. Cognitive Performance - Visual Memory Span [ Time Frame: 6 hrs following acute intervention. ]
    As measured by the Corsi Block Task

  24. Cognitive Performance - Visual Memory Span [ Time Frame: Following 6 weeks chronic intervention ]
    As measured by the Corsi Block Task

  25. Cognitive Performance - Visual Memory Span [ Time Frame: Following 12 weeks chronic intervention ]
    As measured by the Corsi Block Task


Secondary Outcome Measures :
  1. Mood [ Time Frame: 2 hrs following acute intervention. ]
    As measured by the Positive and Negative Affect Schedule

  2. Mood [ Time Frame: 4 hrs following acute intervention. ]
    As measured by the Positive and Negative Affect Schedule

  3. Mood [ Time Frame: 6 hrs following acute intervention. ]
    As measured by the Positive and Negative Affect Schedule

  4. Mood [ Time Frame: Following 6 weeks chronic intervention ]
    As measured by the Positive and Negative Affect Schedule

  5. Mood [ Time Frame: Following 12 weeks chronic intervention ]
    As measured by the Positive and Negative Affect Schedule



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Ages Eligible for Study:   21 Years to 30 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03526406


Locations
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United Kingdom
University of Reading
Reading, Berkshire, United Kingdom, RG6 6AL
Sponsors and Collaborators
University of Reading
Polyphenolics, Inc.
Investigators
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Principal Investigator: Claire M Williams, PhD University of Reading

Publications:
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Responsible Party: Prof Claire Williams, Chair of Neuroscience, University of Reading
ClinicalTrials.gov Identifier: NCT03526406     History of Changes
Other Study ID Numbers: RDG-003
First Posted: May 16, 2018    Key Record Dates
Last Update Posted: July 4, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Prof Claire Williams, University of Reading:
Cognition
Mood
Flavonoid
Grape Seed
Catechin
Epicatechin
Proanthocyanidin
Additional relevant MeSH terms:
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Titanium dioxide
Glycerol
Cryoprotective Agents
Protective Agents
Physiological Effects of Drugs
Sunscreening Agents
Radiation-Protective Agents
Dermatologic Agents
Photosensitizing Agents