CClinicalTrials.gg
CompletedNCT02675621Updated Sep 27, 2018

Investigation of Acute Mood and Cognitive Performance Effects of Beverages Containing Phenolics in Healthy Adults

An interventional study of Phenolic Beverage in Cognitive Function, sponsored by PepsiCo Global R&D. Completed at 1 site in United Kingdom. Open to participants aged 18 Years to 49 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-09-27.

Sponsored by PepsiCo Global R&D · Not applicable, Interventional, and Basic science

From the registry’s dates

  • Registered 3 months after the study started (first participant enrolled Oct 2015, registered Jan 2016).
Phase
Not applicable
Study type
Interventional
Enrollment
46
Allocation
Randomized
Ages
18 Years to 49 Years
Sex
All
01

Study summary

An acute, randomized, placebo controlled, double blinded crossover study in health subjects. Participants will complete 4 intervention arms in random order consisting of a placebo control beverage, a high dose phenolic beverage, a high dose phenolic beverage combined with a fruit extract, and a low does phenolic beverage. The primary objective of the study is to assess the effects of the phenolic compounds, at two different levels, alone and in combination with a fruit extract, on mood and cognitive performance during extended periods of cognitively demanding task performance.

02

Conditions studied

  • Cognitive Function
03

In context

Lead sponsor

PepsiCo Global R&D is the lead sponsor of 101 studies on the registry; 7 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 49 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Aged 18 to 49 years
  • Self-report of good health
  • Are not excluded on the basis of the following exclusion criteria

Exclusion criteria

Exclusion Criteria:

  • Are a smoker
  • Have food allergies or sensitivities to any of the ingredients contained in the investigational product or any other foodstuff
  • Currently take medication except the contraceptive pill
  • Have habitually used dietary supplements within the last month (defined as more than 3 consecutive days or 4 days in total)
  • Have sleep disturbances and/or are taking sleep aid medication Are employed in a job that includes night shift work
  • Have a Body Mass Index (BMI) outside of the range 18-35 kg/m2or weigh less than 50kg or more than 85kg.
  • Have high blood pressure (systolic over 139 mm Hg or diastolic over 89 mm Hg)
  • Have a history of neurological, vascular or psychiatric illness including epilepsy or seizures (excluding depressive illness and anxiety)
  • Have a history of anxiety or a current diagnosis of anxiety or depression
  • Are pregnant, trying to get pregnant or breast feeding
  • Have a recent history of (within 12 months of screening visit) or strong potential for alcohol or substance abuse. Alcohol abuse is defined as more than 60g (men) / 40g (women) pure alcohol per day (7 / 5.5 units)
  • Have learning difficulties or dyslexia
  • Have visual impairment that cannot be corrected with glasses or contact lenses
  • Have frequent migraines that require medication (more than or equal to 1 per month)
  • Have disorders of the blood (e.g. anaemia, hemophilia, thrombocytosis)
  • Have a heart disorder or a history of vascular illness
  • Have a respiratory disorder that requires regular medication (Note: participants with asthma who only take their medication occasionally/as required are eligible for this study)
  • Have a diagnosis of type I or type II diabetes
  • Have a history of renal or hepatic disease, or other severe diseases of the gastrointestinal tract (e.g. iron accumulation, iron utilization disorders, hypercalcaemia, hypercalciuria), that are likely to interfere with metabolism/absorption/secretion of the product under investigation
  • Have any health condition that would prevent fulfillment of the study requirements
  • Are currently or have in the past 8weeks participated in other clinical or nutrition intervention studies
  • Have participated in the BPNRC's recent stress study
  • Do not have a bank account (required for payment)
05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Double (Participant, Investigator)
Enrollment
46 participants (actual)

Study arms

  • Placebo comparator
    Control

    Mix 1 flavored still beverage

    Other: Phenolic Beverage

  • Active comparator
    Phenolic beverage 1

    Mix 2 flavored still beverage with a high dose phenolic extract

    Other: Phenolic Beverage

  • Active comparator
    Phenolic beverage 2

    Mix 3 flavored still beverage with a high dose phenolic extract1 and a fruit extract

    Other: Phenolic Beverage

  • Active comparator
    Phenolic beverage 3

    Mix 4 flavored still beverage with a low dose phenolic extract3 and a fruit extract

    Other: Phenolic Beverage

Interventions

  • OtherPhenolic Beverage
06

What researchers measure

Primary outcomes

  1. Change in mental fatigue

    Time frame: Pre, 1, 3, and 6 hours post-beverage consumption

Secondary outcomes

  1. Changes in mood and cognitive function

    During each assessment mood and psychological state will be assessed before and after performance of an observed multi-tasking stressor via completion of the 'State' subscale of the State-Trait Anxiety Inventory and computerised versions of the Bond-Lader visual analogue mood scales and separate visual analogue scales (VAS) measuring subjective stress, relaxation and calmness.

    Time frame: Pre, 1, 3, and 6 hours post-beverage consumption

07

Study locations

1 site
  • Northumbria University
    Newcastle upon Tyne, NE1 8ST, United Kingdom
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 27, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02675621
Lead sponsor
PepsiCo Global R&D
Collaborators
Northumbria University
Responsible party
Sponsor
First posted
Feb 5, 2016
Start date
Oct 2015
Primary completion
Feb 2016
Completion
Feb 2016
Last update
Sep 27, 2018

Study contacts

David Kennedy, PhD
principal investigator · University of Northumbria

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2018. You cannot join it, but the record below documents what was studied.

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