NCT02675582

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
72

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2015

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2015

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

January 21, 2016

Completed
11 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 5, 2016

Completed
Last Updated

September 27, 2018

Status Verified

September 1, 2018

Enrollment Period

8 months

First QC Date

January 21, 2016

Last Update Submit

September 25, 2018

Conditions

Cognitive Function and Mood

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Change in Cognitive function

    Pre dose, 60, 150, 240 min post dose

Study Arms (4)

Control

PLACEBO COMPARATOR

Mix 1 flavored still beverage

Other: Herbal Beverage

Herbal beverage 1

EXPERIMENTAL

Mix 2 flavored still beverage with a botanical extract(1)

Other: Herbal Beverage

Herbal Beverage 2

EXPERIMENTAL

Mix 3 flavored still beverage with a botanical extract(2)

Other: Herbal Beverage

Combined Herbal Beverage

EXPERIMENTAL

Mix 4 flavored still beverage with 2 botanical extracts (1,2)

Other: Herbal Beverage

Interventions

Herbal BeverageOTHER

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

Combined Herbal BeverageControlHerbal Beverage 2Herbal beverage 1

Eligibility Criteria

Age18 Years - 49 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Aged 18 to 49 years
  • Self-report of good health

You may not qualify if:

  • 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)
  • +8 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Northumbria University

Newcastle upon Tyne, NE1 8ST, United Kingdom

Location

Study Officials

  • David Kennedy, PhD

    Northumbria University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 21, 2016

First Posted

February 5, 2016

Study Start

June 1, 2015

Primary Completion

February 1, 2016

Study Completion

February 1, 2016

Last Updated

September 27, 2018

Record last verified: 2018-09

Locations

GB(1)