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

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.

Study Overview

• Status: Completed
• Conditions: Cognitive Function and Mood
• Intervention / Treatment: Other: Herbal Beverage

• Study Type: Interventional
• Enrollment (Actual): 72
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Newcastle upon Tyne, United Kingdom, NE1 8ST
    • Northumbria University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 49 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

4

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: PepsiCo Global R&D
• Collaborators: Northumbria University
• Investigators: Principal Investigator: David Kennedy, PhD, Northumbria University

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2015
• Primary Completion (Actual): February 1, 2016
• Study Completion (Actual): February 1, 2016

Study Registration Dates

• First Submitted: January 21, 2016
• First Submitted That Met QC Criteria: February 4, 2016
• First Posted (Estimate): February 5, 2016

Study Record Updates

• Last Update Posted (Actual): September 27, 2018
• Last Update Submitted That Met QC Criteria: September 25, 2018
• Last Verified: September 1, 2018

More Information

Terms related to this study

• Other Study ID Numbers: PEP-1509

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided