- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05547204
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:
- 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.
- 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.
- 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
Completed
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
15
Phase
- 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 Locations
-
-
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
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 |
Intervention / Treatment |
---|---|
Experimental: Coffeeberry beverage
300 ml drink containing 300 mg coffeeberry extract
|
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)
|
Free from added carbohydrates (contain 1g CHO only) and electrolytes are absent.
|
What is the study measuring?
Primary Outcome Measures
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
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
Investigators
- 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)
June 30, 2022
Primary Completion (Actual)
December 4, 2022
Study Completion (Actual)
December 4, 2022
Study Registration Dates
First Submitted
September 13, 2022
First Submitted That Met QC Criteria
September 13, 2022
First Posted (Actual)
September 21, 2022
Study Record Updates
Last Update Posted (Actual)
March 16, 2023
Last Update Submitted That Met QC Criteria
March 15, 2023
Last Verified
March 1, 2023
More Information
Terms related to this study
Keywords
Other Study ID 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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