NCT03526406

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 14, 2017

Completed
6 days until next milestone

Study Start

First participant enrolled

November 20, 2017

Completed
6 months until next milestone

First Posted

Study publicly available on registry

May 16, 2018

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2019

Completed
Last Updated

August 20, 2020

Status Verified

August 1, 2020

Enrollment Period

1.3 years

First QC Date

November 14, 2017

Last Update Submit

August 19, 2020

Conditions

Cognitive FunctionMood

Keywords

CognitionMoodFlavonoidGrape SeedCatechinEpicatechinProanthocyanidin

Outcome Measures

Primary Outcomes (25)

  • Cognitive Performance - Episodic Memory

    As Measured by the Auditory Verbal Learning Task

    2 hrs following acute intervention.

  • Cognitive Performance - Episodic Memory

    As Measured by the Auditory Verbal Learning Task

    4 hrs following acute intervention.

  • Cognitive Performance - Episodic Memory

    As Measured by the Auditory Verbal Learning Task

    6 hrs following acute intervention.

  • Cognitive Performance - Episodic Memory

    As Measured by the Auditory Verbal Learning Task

    Following 6 weeks chronic intervention

  • Cognitive Performance - Episodic Memory

    As Measured by the Auditory Verbal Learning Task

    Following 12 weeks chronic intervention

  • Cognitive Performance - Attention shifting

    As measured by the Switching Task

    2 hrs following acute intervention.

  • Cognitive Performance - Attention shifting

    As measured by the Switching Task

    4 hrs following acute intervention.

  • Cognitive Performance - Attention shifting

    As measured by the Switching Task

    6 hrs following acute intervention.

  • Cognitive Performance - Attention shifting

    As measured by the Switching Task

    Following 6 weeks chronic intervention

  • Cognitive Performance - Attention shifting

    As measured by the Switching Task

    Following 12 weeks chronic intervention

  • Cognitive Performance - Motor Control

    As measured by the finger tapping task

    2 hrs following acute intervention.

  • Cognitive Performance - Motor Control

    As measured by the finger tapping task

    4 hrs following acute intervention.

  • Cognitive Performance - Motor Control

    As measured by the finger tapping task

    6 hrs following acute intervention.

  • Cognitive Performance - Motor Control

    As measured by the finger tapping task

    Following 6 weeks chronic intervention

  • Cognitive Performance - Motor Control

    As measured by the finger tapping task

    Following 12 weeks chronic intervention

  • Cognitive Performance - Working Memory

    As measured by the serial 3 and 7s task

    2 hrs following acute intervention.

  • Cognitive Performance - Working Memory

    As measured by the serial 3 and 7s task

    4 hrs following acute intervention.

  • Cognitive Performance - Working Memory

    As measured by the serial 3 and 7s task

    6 hrs following acute intervention.

  • Cognitive Performance - Working Memory

    As measured by the serial 3 and 7s task

    Following 6 weeks chronic intervention

  • Cognitive Performance - Working Memory

    As measured by the serial 3 and 7s task

    Following 12 weeks chronic intervention

  • Cognitive Performance - Visual Memory Span

    As measured by the Corsi Block Task

    2 hrs following acute intervention.

  • Cognitive Performance - Visual Memory Span

    As measured by the Corsi Block Task

    4 hrs following acute intervention.

  • Cognitive Performance - Visual Memory Span

    As measured by the Corsi Block Task

    6 hrs following acute intervention.

  • Cognitive Performance - Visual Memory Span

    As measured by the Corsi Block Task

    Following 6 weeks chronic intervention

  • Cognitive Performance - Visual Memory Span

    As measured by the Corsi Block Task

    Following 12 weeks chronic intervention

Secondary Outcomes (5)

  • Mood

    2 hrs following acute intervention.

  • Mood

    4 hrs following acute intervention.

  • Mood

    6 hrs following acute intervention.

  • Mood

    Following 6 weeks chronic intervention

  • Mood

    Following 12 weeks chronic intervention

Study Arms (2)

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.

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.

Dietary Supplement: Matched Placebo

Interventions

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.

CP9700
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.

Matched Placebo

Eligibility Criteria

Age21 Years - 30 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Non Smoker
  • Not Pregnant
  • Non vegetarian or vegan
  • Able to consume the capsules

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Reading

Reading, Berkshire, RG6 6AL, United Kingdom

Location

Related Publications (3)

  • 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.

    PMID: 19680703BACKGROUND

  • 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.

    PMID: 26690214BACKGROUND

  • 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

    BACKGROUND

Study Officials

  • Claire M Williams, PhD

    University of Reading

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Model Details: Acute on chronic
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chair of Neuroscience

Study Record Dates

First Submitted

November 14, 2017

First Posted

May 16, 2018

Study Start

November 20, 2017

Primary Completion

February 28, 2019

Study Completion

February 28, 2019

Last Updated

August 20, 2020

Record last verified: 2020-08

Data Sharing

IPD Sharing
Will not share

Locations

GB(1)