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

Not Applicable

Completed

• Conditions: Cognitive Function and Mood
• Interventions: Other: Herbal Beverage

• Registration Number: NCT02675582
• Lead Sponsor: PepsiCo Global R&D

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-06
• Study First Submitted: 2016-01-21
• Primary Completion: 2016-02
• Study Completion: 2016-02
• Study First Submitted QC: 2016-02-04
• Study First Posted: 2016-02-05
• Status Verified: 2018-09
• Last Update Submitted: 2018-09-25
• Last Update Posted: 2018-09-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 72

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Control	Herbal Beverage	Mix 1 flavored still beverage
Herbal beverage 1	Herbal Beverage	Mix 2 flavored still beverage with a botanical extract(1)
Herbal Beverage 2	Herbal Beverage	Mix 3 flavored still beverage with a botanical extract(2)
Combined Herbal Beverage	Herbal Beverage	Mix 4 flavored still beverage with 2 botanical extracts (1,2)

Primary Outcome Measures

Name	Time	Method
Change in mood	Pre dose, 60, 150, 240 min post dose	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.

Secondary Outcome Measures

Name	Time	Method
Change in Cognitive function	Pre dose, 60, 150, 240 min post dose	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.

Trial Locations

Locations (1)

Northumbria University; 🇬🇧 Newcastle upon Tyne, United Kingdom