Impact of Coffeeberry Extract on Skill Performance During Simulated Match Play in Academy Football Players

March 15, 2023 updated by: PepsiCo Global R&D

This study of soccer skill performance has three objectives:

  1. Compare effects of coffeeberry (300mg) and placebo ingestion on dribbling speed and precision, passing speed and accuracy, and sprint speed during a full simulated soccer match.
  2. Compare effects of coffeeberry (300mg) and placebo ingestion on subjective measures (mental / physical energy and activation-deactivation (feelings or mood) during a full simulated soccer match.
  3. Compare effects of coffeeberry (300mg) and placebo ingestion on chlorogenic acid (CGA) and caffeine metabolites in the blood 1-hour post ingestion, and other blood metabolites (glucose/lactate) throughout the simulated soccer match.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
15

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United Kingdom
    • Scotland
      • Stirling, Scotland, United Kingdom, FK9 4LA
        • U. Stirling, Health Science and Sport

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

16 years to 28 years (Child, Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Provide valid informed consent prior to any study procedure
  • Male soccer players age 16 to 28 years.
  • >= 5-year soccer playing experience
  • >= 1-year regularly soccer training
  • Free of injuries
  • Willing to avoid alcohol in the 48-h period prior to all visits
  • Willing to avoid caffeinated products and apples, berries/cherries for 24-h prior to all visits
  • Willing to record food intake over the 48-h period prior to the first trial and replicate for second trial
  • Willing to abstain from strenuous physical activity for 24-h before all visits

Exclusion Criteria:

  • Smoking
  • Cardiovascular diseases
  • Diabetes or other metabolic disease • Hypertension (>140/>90 mm Hg)
  • Presence of injuries
  • Major illnesses or surgery in prior 90 days
  • Participation in another clinical trial in the past month

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Coffeeberry beverage
300 ml drink containing 300 mg coffeeberry extract
Other: Beverage
Free from added carbohydrates (contain 1g CHO only) and electrolytes are absent.
Placebo Comparator: Color and flavor matched beverage
300 ml drink (0 mg coffeeberry extract, 0 mg caffeine)
Other: Beverage
Free from added carbohydrates (contain 1g CHO only) and electrolytes are absent.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Dribbling speed
Time Frame: Change from pre-dose baseline through end of match 3.5 hours post consumption at multiple intervals each half of match
m/sec, increase would be better. Simulated soccer match in an indoor gym with pre-set targets.
Change from pre-dose baseline through end of match 3.5 hours post consumption at multiple intervals each half of match
Dribbling precision
Time Frame: Change from pre-dose baseline through end of match 3.5 hours post consumption at multiple intervals each half of match
Meters, more accuracy would be better. Simulated soccer match in an indoor gym with pre-set targets.
Change from pre-dose baseline through end of match 3.5 hours post consumption at multiple intervals each half of match
Passing accuracy
Time Frame: Change from pre-dose baseline through end of match 3.5 hours post consumption at multiple intervals each half of match.
1 to 10 scale, a higher score would be better. Simulated soccer match in an indoor gym with pre-set targets.
Change from pre-dose baseline through end of match 3.5 hours post consumption at multiple intervals each half of match.
Passing speed
Time Frame: Change from pre-dose baseline through end of match 3.5 hours post consumption at multiple intervals each half of match
km/h, increased passing speed would be better. Simulated soccer match in an indoor gym with pre-set targets.
Change from pre-dose baseline through end of match 3.5 hours post consumption at multiple intervals each half of match
Sprint speed.
Time Frame: Change from pre-dose baseline through end of match 3.5 hours post consumption at multiple intervals each half of match
m/sec, increased sprint speed would be better. In indoor gym with marked course.
Change from pre-dose baseline through end of match 3.5 hours post consumption at multiple intervals each half of match

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Blood analyte: Chlorogenic acid (CGA)
Time Frame: Pre-dose baseline, 60 minutes post-dose, half-time, and end of match (3.5 hours)
mmol/L to evaluate primary outcomes. n.a. for placebo. Capillary blood draw for frozen plasma analysis
Pre-dose baseline, 60 minutes post-dose, half-time, and end of match (3.5 hours)
Blood analyte: Caffeine metabolites
Time Frame: Pre-dose baseline, 60 minutes post-dose, half-time, and end of match (3.5 hours)
ug/ml, to evaluate primary outcomes. n.a. for placebo. Capillary blood draw for frozen plasma analysis
Pre-dose baseline, 60 minutes post-dose, half-time, and end of match (3.5 hours)
Blood analyte: Glucose
Time Frame: Pre-dose baseline, 60 minutes post-dose, half-time, and end of match (3.5 hours)
mmol/L, more regulated would be better. Capillary blood draw for frozen plasma analysis
Pre-dose baseline, 60 minutes post-dose, half-time, and end of match (3.5 hours)
Blood analyte: Lactate
Time Frame: Pre-dose baseline, 60 minutes post-dose, half-time, and end of match (3.5 hours)
mmol/L, lower (delayed rise) would be better. Capillary blood draw for frozen plasma analysis
Pre-dose baseline, 60 minutes post-dose, half-time, and end of match (3.5 hours)
Mental energy
Time Frame: Pre-dose baseline, 60 minutes post-dose, half-time, and end of match (3.5 hours)
Visual Analog Scale (VAS), vertical marking on 100 mm horizontal line. Higher energy would be better
Pre-dose baseline, 60 minutes post-dose, half-time, and end of match (3.5 hours)
Physical energy
Time Frame: Pre-dose baseline, 60 minutes post-dose, half-time, and end of match (3.5 hours)
Visual Analog Scale (VAS), vertical marking on 100 mm horizontal line. Higher energy would be better
Pre-dose baseline, 60 minutes post-dose, half-time, and end of match (3.5 hours)
Gut comfort
Time Frame: Pre-dose baseline, 60 minutes post-dose, half-time, and end of match (3.5 hours)
Visual Analog Scale (VAS), vertical marking on 100 mm horizontal line. No or less nausea, fullness or bloating would be better
Pre-dose baseline, 60 minutes post-dose, half-time, and end of match (3.5 hours)
Heart rate
Time Frame: Continuous from pre-dose baseline through end of match (3.5 hours)
By electronic reading. Lower would be better.
Continuous from pre-dose baseline through end of match (3.5 hours)
Hydration status
Time Frame: Pre-dose baseline and end of match (3.5 hours)
Urine osmolality in mOsm/kg change in concentration pre- vs. post-exercise
Pre-dose baseline and end of match (3.5 hours)
Rating of perceived exertion (RPE)
Time Frame: Half-time and end of match (3.5 hours)
By Borg scale, rated 6 to 20, very very light to very very hard. Lower values would be better
Half-time and end of match (3.5 hours)
Activation-deactivation (feelings or mood)
Time Frame: Pre-dose baseline, 60 minutes post-dose, half-time, and end of match (3.5 hours)
Checklist of 20 feelings using a 4 point scale from definitely do feel to definitely don't feel. More relaxed feelings or in a better mood would be better.
Pre-dose baseline, 60 minutes post-dose, half-time, and end of match (3.5 hours)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
PepsiCo Global R&D

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Stuart Galloway, PhD, U. Stirling, Scotland

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 30, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 4, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 4, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 13, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 13, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 21, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 16, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 15, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • PEP-2114

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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