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OpenTrials
Completed

NCT Number: NCT02675582

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.

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Key information

Age range

18 year–49 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Northumbria University

Newcastle upon Tyne, NE1 8ST, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Herbal Beverage

Other

Intervention involves consuming one beverage at the beginning of each visit during the incomplete block design sequence

Primary outcomes

  1. Change in mood

    Time frame: 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 outcomes

  1. Change in Cognitive function

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

PepsiCo Global R&D

Industry

Collaborators

  • Northumbria University

Registry information

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Feb 5, 2016
Registry last updated
Sep 27, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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