- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02675621
Investigation of Acute Mood and Cognitive Performance Effects of Beverages Containing Phenolics in Healthy Adults
September 25, 2018 updated by: PepsiCo Global R&D
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.
Study Overview
Study Type
Interventional
Enrollment (Actual)
46
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Newcastle upon Tyne, United Kingdom, NE1 8ST
- Northumbria University
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 49 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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:
- 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)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Control
Mix 1 flavored still beverage
|
|
Active Comparator: Phenolic beverage 1
Mix 2 flavored still beverage with a high dose phenolic extract
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|
Active Comparator: Phenolic beverage 2
Mix 3 flavored still beverage with a high dose phenolic extract1 and a fruit extract
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Active Comparator: Phenolic beverage 3
Mix 4 flavored still beverage with a low dose phenolic extract3 and a fruit extract
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change in mental fatigue
Time Frame: Pre, 1, 3, and 6 hours post-beverage consumption
|
Pre, 1, 3, and 6 hours post-beverage consumption
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Changes in mood and cognitive function
Time Frame: Pre, 1, 3, and 6 hours post-beverage consumption
|
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.
|
Pre, 1, 3, and 6 hours post-beverage consumption
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: David Kennedy, PhD, University of Northumbria
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 1, 2015
Primary Completion (Actual)
February 1, 2016
Study Completion (Actual)
February 1, 2016
Study Registration Dates
First Submitted
January 21, 2016
First Submitted That Met QC Criteria
February 4, 2016
First Posted (Estimate)
February 5, 2016
Study Record Updates
Last Update Posted (Actual)
September 27, 2018
Last Update Submitted That Met QC Criteria
September 25, 2018
Last Verified
September 1, 2018
More Information
Terms related to this study
Other Study ID Numbers
- PEP-1517
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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