Investigation of Acute Mood and Cognitive Performance Effects of Beverages Containing Phenolics in Healthy Adults
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- PepsiCo Global R&D
- Enrollment
- 46
- Locations
- 2
- Primary Endpoint
- Change in mental fatigue
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Basic Science
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to 49 Years (Adult)
- Sex
- 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
- •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)
Arms & Interventions
Control
Mix 1 flavored still beverage
Intervention: Phenolic Beverage (Other)
Phenolic beverage 1
Mix 2 flavored still beverage with a high dose phenolic extract
Intervention: Phenolic Beverage (Other)
Phenolic beverage 2
Mix 3 flavored still beverage with a high dose phenolic extract1 and a fruit extract
Intervention: Phenolic Beverage (Other)
Phenolic beverage 3
Mix 4 flavored still beverage with a low dose phenolic extract3 and a fruit extract
Intervention: Phenolic Beverage (Other)
Outcomes
Primary Outcomes
Change in mental fatigue
Time Frame: Pre, 1, 3, and 6 hours post-beverage consumption
Secondary Outcomes
- Changes in mood and cognitive function(Pre, 1, 3, and 6 hours post-beverage consumption)