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Acute Effect of Pomegranate Extract on Cognitive Function (POM-03)

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ClinicalTrials.gov Identifier: NCT02935777
Recruitment Status : Completed
First Posted : October 18, 2016
Last Update Posted : October 18, 2016
Sponsor:
Collaborator:
Northumbria University
Information provided by (Responsible Party):
Angela Stockton, Queen Margaret University

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Mental Processes Dietary Supplement: Pomegranate Extract Dietary Supplement: Placebo capsule Phase 1

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Health Services Research
Official Title: Investigation of the Acute Effect of Pomegranate Extract on Cognitive Function in Human Volunteers: A Double-blind, Placebo-controlled, Crossover Trial
Study Start Date : April 2014
Actual Primary Completion Date : July 2014
Actual Study Completion Date : September 2014

Arm Intervention/treatment
Experimental: Pomegranate Extract

POMANOX® pomegranate extract capsules with water by mouth, once. Dosage: 2 capsules

Capsules weigh1.083g and contain: 210mg punicalagin, 328mg other pomegranate polyphenols (e.g. flavonoids and ellagic acid), 0.37mg anthocyanins and maltodextrin.

Dietary Supplement: Pomegranate Extract
The first computer cognitive testing session lasting approximately 45 minutes is undertaken by participants. After completion, intervention capsules are administered. After a 60 minute absorption period, the cognitive testing session is re-administered.
Other Name: POMANOX

Placebo Comparator: Placebo
Identical placebo capsules by mouth, administered once. Dosage 2 capsules. Each capsule contains maltodextrin to provide PE capsule energy equivalent i.e.6.52 kcal or 27.28kJ.
Dietary Supplement: Placebo capsule
One computer cognitive testing session lasting approximately 45 minutes is undertaken by participants. After completion, placebo capsules are administered. After a 60 minute absorption period, the cognitive testing session is re-administered.




Primary Outcome Measures :
  1. Simple reaction time (attention and vigilance, speed of attention) [ Time Frame: 1-2 hours ]
    Reaction time in msec.

  2. 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).

  3. 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.

  4. 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.

  5. 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.

  6. 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).

  7. Rapid Visual Information Processing (RVIP) (cognitive demand) [ Time Frame: 1-2 hours ]
    A series of numbers are displayed individually on the screen in quick succession (at a rate of 100 numbers per minute) and participants are required to respond when they see 3 odd numbers in a row or three even numbers in a row. Measured by % accuracy, no of false alarms and reaction time (ms).

  8. Picture presentation (secondary memory) and delayed recognition(secondary memory, speed and quality of memory) [ Time Frame: 1-2 hours ]
    A series of pictures are displayed on the screen, one at a time. After a delay, all target pictures shown during Picture Presentation plus an equal number of decoys will be displayed on the screen one at a time. For each stimulus participants select 'Yes' or 'No' to indicate if they have seen the picture before or not. The task is measured by reaction time (ms), % accuracy and no of correct responses.

  9. Corsi blocks lite (working memory, spatial memory) [ Time Frame: 1-2 hours ]
    Blue squares on a black background are displayed on the screen. Some of them change to red and back to blue again in a sequence. Participants are required to remember this sequence. The task is repeated five times at each level of difficulty with the sequence span increasing from 4 upwards, until the participant can no longer correctly recall the sequences. The task continues up to 6 squares in each sequence, while participants make enough correct responses. As soon as they make less than 3 correct responses (out of the five in one level) the task will end. All participants complete levels 4-6 regardless of incorrect responses. Results are measured by a span score: This score is calculated as the average of the last 3 correctly completed trials. For example, if the participant correctly responds to all five Level 4 trials and only one Level 5 trial, their span score would be 4.3 [(4 + 4 + 5)/3].


Secondary Outcome Measures :
  1. Pre and post blood pressure changes [ Time Frame: 1-2 hours ]
    Measurement of systolic and diastolic blood pressure in mmHg.

  2. Pre-post cortisol and cortisone changes [ Time Frame: 3-4 hours ]
    Collection of saliva which is processed via ELISA to measure cortisol and cortisone in ng/mL



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy
  • Aged 18-65
  • Enjoy computer tasks

Exclusion Criteria:

  • Diagnosis with any neurological, psychiatric or significant medical condition which could affect cognitive function
  • Known cognitive impairment
  • Use of any prescription, herbal or recreational drugs
  • Gastrointestinal disease
  • Pregnancy or breastfeeding
  • Pomegranate allergy

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): NCT02935777


Locations
United Kingdom
Queen Margaret University
Edinburgh, Scotland, United Kingdom, EH21 6UU
Sponsors and Collaborators
Angela Stockton
Northumbria University
Investigators
Study Director: Emad Aldujaili Dean of Pharmacy, Jordan University

Responsible Party: Angela Stockton, PhD Researcher, Queen Margaret University
ClinicalTrials.gov Identifier: NCT02935777     History of Changes
Other Study ID Numbers: POM-03
First Posted: October 18, 2016    Key Record Dates
Last Update Posted: October 18, 2016
Last Verified: October 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Angela Stockton, Queen Margaret University:
Pomegranate extract
cognitive function
cognition
polyphenols
memory