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Completed

NCT Number: NCT03526406

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

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.

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Key information

Age range

21 year–30 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Reading

Reading, Berkshire, RG6 6AL, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

CP9700

Dietary 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 Placebo

Dietary 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.

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

University of Reading

Other

Collaborators

  • Polyphenolics, Inc.

Registry information

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
May 16, 2018
Registry last updated
Aug 20, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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