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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02675621
Recruitment Status : Completed
First Posted : February 5, 2016
Last Update Posted : September 27, 2018
Sponsor:
Collaborator:
Northumbria University
Information provided by (Responsible Party):
PepsiCo Global R&D

Brief 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.

Condition or disease Intervention/treatment Phase
Cognitive Function Other: Phenolic Beverage Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 46 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Official Title: Investigation of Acute Mood and Cognitive Performance Effects of Beverages Containing Phenolics in Healthy Adults
Actual Study Start Date : October 2015
Actual Primary Completion Date : February 2016
Actual Study Completion Date : February 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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



Primary Outcome Measures :
  1. Change in mental fatigue [ Time Frame: Pre, 1, 3, and 6 hours post-beverage consumption ]

Secondary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 49 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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)

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): NCT02675621


Locations
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United Kingdom
Northumbria University
Newcastle upon Tyne, United Kingdom, NE1 8ST
Sponsors and Collaborators
PepsiCo Global R&D
Northumbria University
Investigators
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Principal Investigator: David Kennedy, PhD University of Northumbria
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Responsible Party: PepsiCo Global R&D
ClinicalTrials.gov Identifier: NCT02675621    
Other Study ID Numbers: PEP-1517
First Posted: February 5, 2016    Key Record Dates
Last Update Posted: September 27, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided