NCT02935777: POM-03

Investigation of the Acute Effect of Pomegranate Extract on Cognitive Function in Human Volunteers: A Double-blind, Placebo-controlled, Crossover Trial

Completed Phase 1 Last updated 13 October 2016

What this trial tests

Phase 1 trial testing Pomegranate Extract in Mental Processes in 20 participants. Completed in 1 September 2014.

Timeline

1 April 2014

Primary endpoint
1 July 2014

1 September 2014

Quick facts

Lead sponsor	Angela Stockton
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	triple
Primary purpose	health services research
Enrollment	20
Start date	1 April 2014
Primary completion	1 July 2014
Estimated completion	1 September 2014
Sites	1 location across United Kingdom

Drugs / interventions tested

• Pomegranate Extract
• Placebo capsule

Conditions studied

• Mental Processes — all drugs for Mental Processes →

Sponsor

Angela Stockton

Who can join

Adults 18 to 65, any sex, with Mental Processes. Healthy volunteers can join.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Simple reaction time (attention and vigilance, speed of attention)
  Time frame: 1-2 hours
  Reaction time in msec.
• Choice reaction time (attention and vigilance, speed and accuracy of attention)
  Time frame: 1-2 hours
  Arrows pointing left and right will appear on the screen at irregular intervals. The participant is required to indicate the direction of the arrow as quickly as possible, whenever an arrow is displayed. Measured by % accuracy, overall correct responses and reaction time (ms).
• Bond Lader mood scales
  Time frame: 1-2 hours
  Mood is measured via the Bond Lader series of mood scales, each scored out of 100. From these scales three composite scores are calculated describing feelings of 'Alert', 'Calm' and 'Content', also presented as a score out of 100.
• Digit vigilance (attention and vigilance, speed and accuracy of attention)
  Time frame: 1-2 hours
  A fixed number will appear on the right of the screen and a series of changing numbers will appear on the left side of the screen. Participants are required to make a response when the number on the left matches the number on the right. Measured by reaction time (ms) and %accuracy of responses.
• Word presentation (secondary memory) then delayed Word recall (quality of memory)
  Time frame: 1-2 hours
  A list of words is displayed on the screen, one word at a time. Participants are given 60 seconds to write down as many of the words they were shown earlier as they can. This task was performed following following a delay between the presentation and recall (delayed recall). no of correct responses and % accuracy.
• Word recognition (secondary memory, quality and speed of memory)
  Time frame: 1-2 hours
  All target words that were shown during Word Presentation plus an equal number of decoys will be displayed on the screen one at a time. Participants indicate if they remember seeing the word earlier or not. measured by correct no of responses, errors and reaction time (ms).

Sponsor's own description

The double-blinded, randomised, placebo-controlled crossover pilot study is conducted as a two week intervention after a pre-intervention registration and preparation period.

This study explores whether acute supplementation with pomegranate extract can modulate indicators of cognitive function and mood in healthy adults. Changes in physiological and biochemical markers are also investigated.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.