Investigation of the Acute Calming Effects of Drinks Containing Herbal Extracts in Healthy Adults

Study Overview
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Brief Summary
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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.

Official Title
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Investigation of the Acute Calming Effects of Drinks Containing Herbal Extracts in Healthy Adults

Conditions
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Cognitive Function and Mood

Intervention / Treatment
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* Other: Herbal Beverage


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 49 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Control<br>Mix 1 flavored still beverage | Other: Herbal Beverage<br>* Intervention involves consuming one beverage at the beginning of each visit during the incomplete block design sequence<br>|
| Experimental: Herbal beverage 1<br>Mix 2 flavored still beverage with a botanical extract(1) | Other: Herbal Beverage<br>* Intervention involves consuming one beverage at the beginning of each visit during the incomplete block design sequence<br>|
| Experimental: Herbal Beverage 2<br>Mix 3 flavored still beverage with a botanical extract(2) | Other: Herbal Beverage<br>* Intervention involves consuming one beverage at the beginning of each visit during the incomplete block design sequence<br>|
| Experimental: Combined Herbal Beverage<br>Mix 4 flavored still beverage with 2 botanical extracts (1,2) | Other: Herbal Beverage<br>* Intervention involves consuming one beverage at the beginning of each visit during the incomplete block design sequence<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |