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

PepsiCo

Status: Completed

Conditions: Cognitive Function and Mood

Treatments: Other: Herbal Beverage

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02675582

PEP-1509

Details and patient eligibility

About

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.

Enrollment: 72 patients

Sex: All

Ages: 18 to 49 years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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72 participants in 4 patient groups, including a placebo group

Control

Placebo Comparator group

Description:

Mix 1 flavored still beverage

Treatment:

Other: Herbal Beverage

Herbal beverage 1

Experimental group

Description:

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

Treatment:

Other: Herbal Beverage

Herbal Beverage 2

Experimental group

Description:

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

Treatment:

Other: Herbal Beverage

Combined Herbal Beverage

Experimental group

Description:

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

Treatment:

Other: Herbal Beverage