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

NCT ID: NCT02675582

Last Updated: 2018-09-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 72 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-06-30
• Study Completion Date: 2016-02-29

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.

Conditions

Cognitive Function and Mood

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: DOUBLE

Study Groups

Control

Mix 1 flavored still beverage

Group Type: PLACEBO_COMPARATOR

Herbal Beverage

Intervention Type: OTHER

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

Herbal beverage 1

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

Group Type: EXPERIMENTAL

Herbal Beverage

Intervention Type: OTHER

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

Herbal Beverage 2

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

Group Type: EXPERIMENTAL

Herbal Beverage

Intervention Type: OTHER

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

Combined Herbal Beverage

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

Group Type: EXPERIMENTAL

Herbal Beverage

Intervention Type: OTHER

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

Interventions

Herbal Beverage

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

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

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

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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 49 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Northumbria University

OTHER

Sponsor Role: collaborator

PepsiCo Global R&D

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

David Kennedy, PhD

Role: PRINCIPAL_INVESTIGATOR

Northumbria University

Locations

Northumbria University

Newcastle upon Tyne, , United Kingdom

Countries

United Kingdom

Other Identifiers

PEP-1509

Identifier Type: -

Identifier Source: org_study_id