Clinical trial NCT02675582: Investigation of the Acute Calming Effects of Drinks Containing Herbal Extracts in Healthy Adults
Official title: Investigation of the Acute Calming Effects of Drinks Containing Herbal Extracts in Healthy Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cognitive Function and Mood
Lead sponsor: PepsiCo Global R&D
Sponsor class: INDUSTRY
Collaborators: name: Northumbria University
First posted: 2016-02-05
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: 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.


Eligibility 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)

Primary outcomes:
measure: Change in mood
timeFrame: Pre dose, 60, 150, 240 min post dose
Secondary outcomes:
measure: Change in Cognitive function
timeFrame: Pre dose, 60, 150, 240 min post dose
Other outcomes:
Locations:
city: Newcastle upon Tyne
country: United Kingdom
facility: Northumbria University
Study officials:
affiliation: Northumbria University
name: David Kennedy, PhD
role: PRINCIPAL_INVESTIGATOR
References: