Effect of Coffeeberry on Mood and Cognitive Performance

NCT04975802 | Completed

• 1 other identifier: PEP-2005
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

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.

Conditions

Mental Fatigue; Alertness; Mood; Cognition

Keywords

alertness; mental fatigue; coffeeberry; coffee fruit

Outcome Measures

Primary Outcomes (2)

• Mental fatigue Visual Analog Scale (VAS) score

  0-100 mm subjective rating scale, not at all to extremely, within Computerised Mental Performance Assessment framework tasks (COMPASS)

  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.

• Mental alertness Visual Analog Scale (VAS) score

  0-100 mm subjective rating scale, not at all to extremely, within Computerised Mental Performance Assessment framework tasks (COMPASS)

  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.

Secondary Outcomes (10)

• 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

• 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.

• 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.

• 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.

• 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.

Study Arms (4)

0 mg coffeeberry beverage

PLACEBO COMPARATOR

Appearance-matched to the other products

Other: Placebo

100 mg coffeeberry beverage

EXPERIMENTAL

Appearance-matched to the other products

Dietary Supplement: Coffeeberry

300 mg coffeeberry beverage

EXPERIMENTAL

Appearance-matched to the other products

Dietary Supplement: Coffeeberry

75 mg caffeine beverage

ACTIVE COMPARATOR

Appearance-matched to the other products

Dietary Supplement: Caffeine

Interventions

Placebo OTHER

10 oz (296 ml) cherry flavored still beverage

0 mg coffeeberry beverage

Coffeeberry DIETARY_SUPPLEMENT

10 oz (296 ml) cherry flavored still beverage

100 mg coffeeberry beverage; 300 mg coffeeberry beverage

Caffeine DIETARY_SUPPLEMENT

10 oz (296 ml) cherry flavored still beverage

75 mg caffeine beverage

Eligibility Criteria

• Age: 18 Years - 49 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• PepsiCo Global R&D: lead

Study Sites (1)

Brain, Performance and Nutrition Research Centre Northumbria University

Newcastle upon Tyne, NE1 8ST, United Kingdom

Location

MeSH Terms

Conditions

Mental Fatigue

Interventions

Caffeine

Condition Hierarchy (Ancestors)

Fatigue; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Xanthines; Alkaloids; Heterocyclic Compounds; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Philippa Jackson, PhD

  Northumbria University Newcastle, UK

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 14, 2021
• First Posted: July 23, 2021
• Study Start: July 5, 2021
• Primary Completion: February 4, 2022
• Study Completion: February 4, 2022
• Last Updated: March 24, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)