Cognitive Function and Mood Clinical Trial
Official title:
Investigation of the Acute Calming Effects of Drinks Containing Herbal Extracts in Healthy Adults
NCT number | NCT02675582 |
Other study ID # | PEP-1509 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | June 2015 |
Est. completion date | February 2016 |
Verified date | September 2018 |
Source | PepsiCo Global R&D |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The primary objectives of this study are to assess the effects of three investigational drinks containing three botanicals in differing combinations versus a placebo control, on mood, psychological state, physical response, and cognitive performance during and after exposure to an observed multi-tasking stressor.
Status | Completed |
Enrollment | 72 |
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) |
Country | Name | City | State |
---|---|---|---|
United Kingdom | Northumbria University | Newcastle upon Tyne |
Lead Sponsor | Collaborator |
---|---|
PepsiCo Global R&D | Northumbria University |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in mood | 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 dose, 60, 150, 240 min post dose | |
Secondary | Change in 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 dose, 60, 150, 240 min post dose |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
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