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

Cognitive Function Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02675621
• Other study ID #: PEP-1517
• Status: Completed
• Phase: N/A
• Start date: October 2015
• Est. completion date: February 2016

Study information

• Verified date: September 2018
• Source: PepsiCo Global R&D
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 46
• Est. completion date: February 2016
• Est. primary completion date: February 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 49 Years

Eligibility

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)

Related Conditions & MeSH terms

• Cognitive Function

Intervention

Other:
• Phenolic Beverage

Locations

Country	Name	City	State
United Kingdom	Northumbria University	Newcastle upon Tyne

Sponsors (2)

Lead Sponsor	Collaborator
PepsiCo Global R&D	Northumbria University

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in mental fatigue		Pre, 1, 3, and 6 hours post-beverage consumption
Secondary	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.	Pre, 1, 3, and 6 hours post-beverage consumption