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

PepsiCo logo

PepsiCo

Status

Completed

Conditions

Cognitive Function

Treatments

Other: Phenolic Beverage

Study type

Interventional

Funder types

Other
Industry

Identifiers

NCT02675621
PEP-1517

Details and patient eligibility

About

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.

Enrollment

46 patients

Sex

All

Ages

18 to 49 years old

Volunteers

Accepts Healthy Volunteers

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)

Trial design

Primary purpose

Basic Science

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Double Blind

46 participants in 4 patient groups, including a placebo group

Control
Placebo Comparator group
Description:
Mix 1 flavored still beverage
Treatment:
Other: Phenolic Beverage
Phenolic beverage 1
Active Comparator group
Description:
Mix 2 flavored still beverage with a high dose phenolic extract
Treatment:
Other: Phenolic Beverage
Phenolic beverage 2
Active Comparator group
Description:
Mix 3 flavored still beverage with a high dose phenolic extract1 and a fruit extract
Treatment:
Other: Phenolic Beverage
Phenolic beverage 3
Active Comparator group
Description:
Mix 4 flavored still beverage with a low dose phenolic extract3 and a fruit extract
Treatment:
Other: Phenolic Beverage

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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