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

Cognitive Function and Mood Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02675582
• Other study ID #: PEP-1509
• Status: Completed
• Phase: N/A
• Start date: June 2015
• Est. completion date: February 2016

Study information

• Verified date: September 2018
• Source: PepsiCo Global R&D
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• 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)

Related Conditions & MeSH terms

• Cognitive Function and Mood

Intervention

Other:
• Herbal Beverage
Intervention involves consuming one beverage at the beginning of each visit during the incomplete block design sequence

Locations

Country	Name	City	State
United Kingdom	Northumbria University	Newcastle upon Tyne

Sponsors (2)

Lead Sponsor	Collaborator
PepsiCo Global R&D	Northumbria University

Country where clinical trial is conducted

United Kingdom, 

Outcome

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