Effect of Coffeeberry on Mood and Cognitive Performance

PepsiCo

Status: Completed

Conditions: Alertness; Mental Fatigue; Mood; Cognition

Treatments: Other: Placebo; Dietary Supplement: Coffeeberry; Dietary Supplement: Caffeine

Study type: Interventional

Funder types: Industry

Identifiers

NCT04975802

PEP-2005

Details and patient eligibility

About

The primary aim of this randomised, double-blind, placebo-controlled, cross-over study is to assess the short-term cognitive effects of two beverages containing 100 and 300 mg coffeeberry extract (obtained from the fruit of the coffee plant (Coffea arabica) compared to a placebo beverage. The trial will utilise the COMPASS cognitive assessment system and cognitive demand battery (CDB) and mood visual analogue scales (VAS) with assessments taking place at baseline, 60- and 120-minutes post treatment, on four separate testing days separated by 7 days. A treatment containing 75 mg caffeine will be used as a positive control to document participants' responsiveness to an established psychostimulant.

Enrollment: 72 patients

Sex: All

Ages: 18 to 49 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Participants are aged 18-49 years, inclusive
• Participants self-report that they are in good health
• Willing to maintain habitual diet, physical activity pattern, and body weight throughout the trial
• Willing to abstain from consumption of caffeine within 12 h of testing
• Willing to abstain from alcohol consumption and avoid vigorous physical activity for 24 h prior to all test visits
• Willing to refrain from 'over the counter' medications (e.g. pain medication) and stimulant medication for 12 hours, seasonal allergy/hay fever nasal antihistamine medications for 24 hours and oral antihistamines for 48 hours prior to all test visits
• Understanding the study procedures and willing to provide informed consent to participate in the study and authorization to release relevant protected health information to the study Investigator.

Exclusion criteria

• Failure to meet any one of the inclusion criteria
• Current use of prescription medication, except for contraceptives
• Report hypersensitivity to caffeine
• Major trauma or major surgical event within 6 months of screening
• Extreme dietary habits, as judged by the Investigator (high fat, very high protein diets, intermittent fasting, etc.)
• Exposure to coffeeberry within 30 d prior to screening
• History of cancer in the prior two years, except for non-melanoma skin cancer
• Have a visual impairment that cannot be corrected with glasses or contact lenses
• Food allergies/intolerances/sensitivities to any ingredients in the study products (including coffee or related foods/beverages/products)
• Self-report excessive leisure time physical activity (> 7 strenuous bouts per week)
• Have a current or chronic gastrointestinal, sleep, or psychiatric disorders
• Work night shifts or follow a variable work pattern that results in irregular sleep pattern
• Are pregnant, trying to get pregnant or lactating
• Smoke tobacco, vape nicotine or use nicotine replacement products
• Use illegal/recreational drugs
• Unable to demonstrate adequate minimal performance on lab, computer-based cognitive tasks
• Have participated in another clinical trial within past 30 days and/or participation in another PepsiCo trial in the past 6 months
• Have high blood pressure (systolic over 139 mm Hg or diastolic over 89 mm Hg)
• Have a Body Mass Index (BMI) outside of the range 18.5-35 kg/m2
• Have learning and/or behavioural disorders such as dyslexia or ADHD
• Excessive caffeine intake (>500 mg per day)
• Have taken dietary supplements e.g. Vitamins, omega 3 fish oils etc. in the last 4 weeks (Note: participation is possible following a 4 week supplement washout prior to participating and for the duration of the study on the proviso that the supplements they are taking are out of choice and not medically prescribed or advised)
• Have any health condition that would prevent fulfilment of the study requirements (this includes non-diagnosed conditions for which no medication may be taken)
• Has been diagnosed with/ undergoing treatment for alcohol or drug abuse in the last 12 months
• Have been diagnosed with/ undergoing treatment for a psychiatric disorder in the last 12 months
• Suffers from frequent migraines that require medication (more than or equal to 1 per month)
• Any known active infections
• Does not have a bank account (required for payment)

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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72 participants in 4 patient groups, including a placebo group

0 mg coffeeberry beverage

Placebo Comparator group

Description:

Appearance-matched to the other products

Treatment:

Other: Placebo

100 mg coffeeberry beverage

Experimental group

Description:

Appearance-matched to the other products

Treatment:

Dietary Supplement: Coffeeberry

300 mg coffeeberry beverage

Experimental group

Description:

Appearance-matched to the other products

Treatment:

Dietary Supplement: Coffeeberry

75 mg caffeine beverage

Active Comparator group

Description:

Appearance-matched to the other products

Treatment:

Dietary Supplement: Caffeine