- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04181619
Influence of Coffeeberry Ingestion on Soccer Skill Performance
March 23, 2022 updated by: PepsiCo Global R&D
Influence of Coffeeberry Extract on Soccer Specific Skill Performance After Rest, During Simulated Soccer Match Play, and Following Fatiguing Exercise in Academy Football Players
The study of soccer skill performance has 3 objectives.
Objective 1 is to compare effects of coffeeberry (300mg) and placebo ingestion on dribbling speed and precision and passing and shooting speed and accuracy compared to placebo.
30 subjects will be assessed before dosing, after a 1 hr resting absorption period, and after simulated soccer match play.
Of these 30, 20 subjects will proceed to Objective 2 (45 minutes of intense simulated soccer match play) and Objective 3 (repeated sprint activity continued until volitional fatigue).
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
30
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
- University of 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 (ADULT, CHILD)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Male
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 main trials.
- Willing to avoid caffeine, caffeinated and decaffeinated products, apples, and, berries/cherries for 24-h prior to main trials
- 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
- 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
- Masking: QUADRUPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
EXPERIMENTAL: Coffeeberry beverage
300 mg Coffeeberry extract in 300 ml beverage
|
One exposure of 300 mg coffeeberry extract in a 300 ml flavored still beverage prior to exercise session
|
|
PLACEBO_COMPARATOR: Color and flavor matched beverage
0 mg Coffeeberry extract in 300 ml flavor and color-matched beverage
|
One 300 ml still beverage, color and flavor matched to experimental beverage prior to exercise session
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Dribbling speed
Time Frame: During 3.5 hours post consumption
|
m/sec, increase would be better.
Simulated match in an indoor gym with pre-set targets.
|
During 3.5 hours post consumption
|
|
Dribbling precision
Time Frame: During 3.5 hours post consumption
|
Meters, more accuracy would be better.
Simulated match in an indoor gym against pre-set targets.
|
During 3.5 hours post consumption
|
|
Passing accuracy
Time Frame: During 3.5 hours post consumption
|
1-10 scale, higher score would be better.
Simulated match in an indoor gym against pre-set targets.
|
During 3.5 hours post consumption
|
|
Passing speed by Time
Time Frame: During 3.5 hours post consumption
|
km/h, increased would be better.
Simulated match in an indoor gym against pre-set targets.
|
During 3.5 hours post consumption
|
|
Shooting accuracy
Time Frame: During 3.5 hours post consumption
|
More shots on target would be better.
Simulated match in an indoor gym against pre-set targets.
|
During 3.5 hours post consumption
|
|
Shooting speed
Time Frame: During 3.5 hours post consumption
|
Milliseconds, faster would be better.
Simulated match in an indoor gym against pre-set targets.
|
During 3.5 hours post consumption
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Sprint speed
Time Frame: During 3.5 hours post consumption
|
m/sec, increase would be better.
In indoor gym with marked course.
|
During 3.5 hours post consumption
|
|
High-intensity endurance running capacity
Time Frame: During 3.5 hours post consumption
|
Run time to volitional fatigue in min, increase would be better.
In indoor gym with marked course.
|
During 3.5 hours post consumption
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Blood analyte concentration: Capillary glucose
Time Frame: During 3.5 hours post consumption
|
(mmol/L), more regulated would be better
|
During 3.5 hours post consumption
|
|
Blood analyte concentration: Capillary lactate
Time Frame: During 3.5 hours post consumption
|
(mmol/L), lower (delayed rise) would be better
|
During 3.5 hours post consumption
|
|
Blood analyte concentration: Serum chlorogenic acid
Time Frame: During 3.5 hours post consumption
|
(mmol/L), n.a. for placebo, introduced to evaluate primary outcomes
|
During 3.5 hours post consumption
|
|
Blood analyte concentration: Serum caffeine
Time Frame: During 3.5 hours post consumption
|
(ug/mL), n.a. for placebo, Introduced to evaluate primary outcomes
|
During 3.5 hours post consumption
|
|
Rate of Perceived Exertion (RPE)
Time Frame: During 3.5 hours post consumption
|
By Borg scale, rated 6-20, lower values would be better
|
During 3.5 hours post consumption
|
|
Activation/Deactivation (feelings and mood)
Time Frame: During 3.5 hours post consumption
|
Checklist of feelings using a 4 point scale from definitely do to definitely don't feel, more relaxed and better mood would be better
|
During 3.5 hours post consumption
|
|
Mental energy
Time Frame: During 3.5 hours post consumption
|
By Visual Analog Scale (VAS) vertical marking on 100 mm horizontal line, higher energy would be better
|
During 3.5 hours post consumption
|
|
Physical energy
Time Frame: During 3.5 hours post consumption
|
By Visual Analog Scale (VAS) vertical marking on 100 mm horizontal line, higher energy would be better
|
During 3.5 hours post consumption
|
|
Heart rate
Time Frame: During 3.5 hours post consumption
|
By electronic reading, lower would be better
|
During 3.5 hours post consumption
|
|
Gut comfort
Time Frame: During 3.5 hours post consumption
|
By Visual Analog Scale (VAS) vertical marking on 100 mm horizontal scale, no or less nausa, fullness or bloating would be better
|
During 3.5 hours post consumption
|
|
Hydration status
Time Frame: During 3.5 hours post consumption
|
Urine osmolality in mOsm/kg, comparing pre- vs. post-exercise concentration
|
During 3.5 hours post consumption
|
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
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)
November 6, 2019
Primary Completion (ACTUAL)
August 3, 2021
Study Completion (ACTUAL)
August 3, 2021
Study Registration Dates
First Submitted
November 26, 2019
First Submitted That Met QC Criteria
November 26, 2019
First Posted (ACTUAL)
November 29, 2019
Study Record Updates
Last Update Posted (ACTUAL)
March 24, 2022
Last Update Submitted That Met QC Criteria
March 23, 2022
Last Verified
March 1, 2022
More Information
Terms related to this study
Other Study ID Numbers
- PEP-1904
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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