Effect of Coffeeberry on Mood and Cognitive Performance

Sponsor

PepsiCo Global R&D (Industry)

Overall Status

Completed

CT.gov ID

NCT04975802

Collaborator

(none)

Enrollment

Location

Arms

Actual Duration (Months)

10.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Mental Fatigue Alertness Mood Cognition	Other: Placebo Dietary Supplement: Coffeeberry Dietary Supplement: Caffeine	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

72 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Basic Science

Official Title:

Effect of Coffeeberry on Mood and Cognitive Performance

Actual Study Start Date :

Jul 5, 2021

Actual Primary Completion Date :

Feb 4, 2022

Actual Study Completion Date :

Feb 4, 2022

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: 0 mg coffeeberry beverage Appearance-matched to the other products	Other: Placebo 10 oz (296 ml) cherry flavored still beverage
Experimental: 100 mg coffeeberry beverage Appearance-matched to the other products	Dietary Supplement: Coffeeberry 10 oz (296 ml) cherry flavored still beverage
Experimental: 300 mg coffeeberry beverage Appearance-matched to the other products	Dietary Supplement: Coffeeberry 10 oz (296 ml) cherry flavored still beverage
Active Comparator: 75 mg caffeine beverage Appearance-matched to the other products	Dietary Supplement: Caffeine 10 oz (296 ml) cherry flavored still beverage

Outcome Measures

Primary Outcome Measures

Mental fatigue Visual Analog Scale (VAS) score [Change from baseline to 120 min post-coffeeberry beverage (100 and 300 mg) consumption during a Cognitive Demand Battery (CDB), compared to placebo beverages. Less mental fatigue is better.]
0-100 mm subjective rating scale, not at all to extremely, within Computerised Mental Performance Assessment framework tasks (COMPASS)
Mental alertness Visual Analog Scale (VAS) score [Change from baseline to 120 min post-coffeeberry beverage (100 and 300 mg) consumption during a Cognitive Demand Battery (CDB), compared to placebo beverages. More mental alertness is better.]
0-100 mm subjective rating scale, not at all to extremely, within Computerised Mental Performance Assessment framework tasks (COMPASS)

Secondary Outcome Measures

Mental fatigue Visual Analog Scale (VAS) score [Change from baseline to 60 min post-coffeeberry beverage (100 and 300 mg) consumption, during a Cognitive Demand Battery (CDB), compared to placebo and caffeine beverages]
0-100 mm subjective rating scale, not at all to extremely, within Computerised Mental Performance Assessment framework tasks (COMPASS). Less mental fatigue is better.
Mental Alertness Visual Analog Scale (VAS) score [Change from baseline to 60 min post-coffeeberry beverage (100 and 300 mg) consumption, during a Cognitive Demand Battery (CDB), compared to placebo and caffeine beverages. More mental alertness is better.]
0-100 mm subjective rating scale, not at all to extremely, from within Computerised Mental Performance Assessment framework tasks (COMPASS)
Motivation Visual Analog Scale (VAS) score [Change from baseline to 60 and 120 min post-coffeeberry beverage (100 and 300 mg) consumption, during a Cognitive Demand Battery (CDB), compared to placebo and caffeine beverages. More motivation is better.]
0-100 mm subjective rating scale from none to strongest feelings, within Computerised Mental Performance Assessment framework tasks (COMPASS)
Fatigue (Mental State Energy and Fatigue Scales, (EFS)) score [Change from baseline to 60 and 120 min post-coffeeberry beverage (100 and 300 mg) consumption, following CBD, compared to placebo and caffeine beverages. Less fatigue is better.]
Subjective feelings of mental energy and mental fatigue. Intensity rating scale from none to strongest, yields composite score ranging from 0-300, included within Computerised Mental Performance Assessment framework tasks (COMPASS)
Fatigue (Physical State Energy and Fatigue Scales, (EFS)) score [Change from baseline to 60 and 120 min post-coffeeberry beverage (100 and 300 mg) consumption, following CBD, compared to placebo and caffeine beverages. Less fatigue is better.]
Subjective feelings of physical energy and physical fatigue. Intensity rating scale from none to strongest, yields composite score ranging from 0-300, included within Computerised Mental Performance Assessment framework tasks (COMPASS)
Alertness (Bond Lader Visual Analog Scale (VAS)) score [Change from baseline to 60 and 120 min post-coffeeberry beverage (100 and 300 mg) consumption, following CBD, compared to placebo and caffeine beverages. More alertness is better.]
0-100 mm subjective rating scale of intensity of feelings within Computerised Mental Performance Assessment framework tasks (COMPASS)
Calmness (Bond Lader Visual Analog Scale (VAS)) score [Change from baseline to 60 and 120 min post-coffeeberry beverage (100 and 300 mg) consumption, following CBD, compared to placebo and caffeine beverages. More calmness is better.]
0-100 mm subjective rating scale of intensity of feelings within Computerised Mental Performance Assessment framework tasks (COMPASS)
Contentedness (Bond Lader Visual Analog Scale (VAS)) score [Change from baseline to 60 and 120 min post-coffeeberry beverage (100 and 300 mg) consumption, following CBD, compared to placebo and caffeine beverages. More contentedness is better.]
0-100 mm subjective rating scale of intensity of feelings within Computerised Mental Performance Assessment framework tasks (COMPASS)
Change in cognitive function measures (Serial subtraction tasks, rapid visual information processing) scores [Change from baseline to 60 and 120 min post-coffeeberry beverage (100 and 300 mg) consumption, compared to placebo and caffeine beverages. Higher scores are better.]
Objective tests within Computerised Mental Performance Assessment framework tasks (COMPASS)
Episodic memory tasks (delayed word recall, delayed word recognition, delayed picture recognition) score [Comparison of recollection between coffeeberry beverage (100 and 300 mg), placebo and caffeine beverages to stimuli presented at baseline versus 120 min post-consumption. More recall is better.]
Objective tests within Computerised Mental Performance Assessment framework tasks (COMPASS)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 49 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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)