Skill PerformanceNCT05547204
Impact of Coffeeberry Extract on Skill Performance During Simulated Match Play in Academy Football Players
A study testing Beverage in people with Skill Performance and Soccer Performance, run by PepsiCo Global R&D at 1 site in United Kingdom.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 16 to 28 yearsHealthy volunteers can take part
- Conditions the study is for
- Skill Performance, Soccer Performance, Coffeeberry Effects
- What is being tested?
- Beverage
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 15 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 30 Jun 2022to 4 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 28 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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
Show all 9Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
U. Stirling, Health Science and Sport
Stirling, Scotland, FK9 4LA
About this study
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.
- Conditions
- Skill Performance, Soccer Performance, Coffeeberry Effects
- Being tested
- Beverage
- Keywords
- coffeeberry, caffeine, polyphenols, chlorogenic acid, exercise, soccer, football, skill, performance
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BeverageOther
Free from added carbohydrates (contain 1g CHO only) and electrolytes are absent.
| Study group | Role | What they receive |
|---|---|---|
| Coffeeberry beverage | Experimental | 300 ml drink containing 300 mg coffeeberry extract Receives: Other: Beverage |
| Color and flavor matched beverage | Placebo comparator | 300 ml drink (0 mg coffeeberry extract, 0 mg caffeine) Receives: Other: Beverage |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dribbling speed
m/sec, increase would be better. Simulated soccer match in an indoor gym with pre-set targets.
Measured: Change from pre-dose baseline through end of match 3.5 hours post consumption at multiple intervals each half of match
Dribbling precision
Meters, more accuracy would be better. Simulated soccer match in an indoor gym with pre-set targets.
Measured: Change from pre-dose baseline through end of match 3.5 hours post consumption at multiple intervals each half of match
Passing accuracy
1 to 10 scale, a higher score would be better. Simulated soccer match in an indoor gym with pre-set targets.
Measured: Change from pre-dose baseline through end of match 3.5 hours post consumption at multiple intervals each half of match.
Passing speed
km/h, increased passing speed would be better. Simulated soccer match in an indoor gym with pre-set targets.
Measured: Change from pre-dose baseline through end of match 3.5 hours post consumption at multiple intervals each half of match
Sprint speed.
m/sec, increased sprint speed would be better. In indoor gym with marked course.
Measured: Change from pre-dose baseline through end of match 3.5 hours post consumption at multiple intervals each half of match
Secondary outcomes (11)
Blood analyte: Chlorogenic acid (CGA)
mmol/L to evaluate primary outcomes. n.a. for placebo. Capillary blood draw for frozen plasma analysis
Measured: Pre-dose baseline, 60 minutes post-dose, half-time, and end of match (3.5 hours)
Blood analyte: Caffeine metabolites
ug/ml, to evaluate primary outcomes. n.a. for placebo. Capillary blood draw for frozen plasma analysis
Measured: Pre-dose baseline, 60 minutes post-dose, half-time, and end of match (3.5 hours)
Blood analyte: Glucose
mmol/L, more regulated would be better. Capillary blood draw for frozen plasma analysis
Measured: Pre-dose baseline, 60 minutes post-dose, half-time, and end of match (3.5 hours)
Blood analyte: Lactate
mmol/L, lower (delayed rise) would be better. Capillary blood draw for frozen plasma analysis
Measured: Pre-dose baseline, 60 minutes post-dose, half-time, and end of match (3.5 hours)
Rating of perceived exertion (RPE)
By Borg scale, rated 6 to 20, very very light to very very hard. Lower values would be better
Measured: Half-time and end of match (3.5 hours)
Activation-deactivation (feelings or mood)
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.
Measured: Pre-dose baseline, 60 minutes post-dose, half-time, and end of match (3.5 hours)
Mental energy
Visual Analog Scale (VAS), vertical marking on 100 mm horizontal line. Higher energy would be better
Measured: Pre-dose baseline, 60 minutes post-dose, half-time, and end of match (3.5 hours)
Physical energy
Visual Analog Scale (VAS), vertical marking on 100 mm horizontal line. Higher energy would be better
Measured: Pre-dose baseline, 60 minutes post-dose, half-time, and end of match (3.5 hours)
Gut comfort
Visual Analog Scale (VAS), vertical marking on 100 mm horizontal line. No or less nausea, fullness or bloating would be better
Measured: Pre-dose baseline, 60 minutes post-dose, half-time, and end of match (3.5 hours)
Heart rate
By electronic reading. Lower would be better.
Measured: Continuous from pre-dose baseline through end of match (3.5 hours)
Hydration status
Urine osmolality in mOsm/kg change in concentration pre- vs. post-exercise
Measured: Pre-dose baseline and end of match (3.5 hours)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2022
- Study start30 Jun 2022
- Primary completion4 Dec 2022
- Study completion4 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Skill PerformanceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- PepsiCo Global R&D
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Stuart Galloway, PhD, Principal investigator, U. Stirling, Scotland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05547204
- Sponsor's protocol ID
- PEP-2114
- Status last verified
- Mar 2023
- First submitted
- 13 Sep 2022
- Last updated
- 16 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Coffeeberry Extract on Skill Performance During Simulated Match Play in Academy Football Players
- ClinicalTrials.gov ID
- NCT05547204
- Acronym / sponsor ID
- PEP-2114
- Conditions
- Skill Performance, Soccer Performance, Coffeeberry Effects
- Keywords
- coffeeberry, caffeine, polyphenols, chlorogenic acid, exercise, soccer, football, skill
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- PepsiCo Global R&DIndustry (pharma, biotech, devices)
- Study start
- 30 Jun 2022 (actual)
- Primary completion
- 4 Dec 2022 (actual)
- Study completion
- 4 Dec 2022 (actual)
- First posted
- 21 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Coffeeberry beverage | Experimental | Other: Beverage300 ml drink containing 300 mg coffeeberry extract |
| Color and flavor matched beverage | Placebo comparator | Other: Beverage300 ml drink (0 mg coffeeberry extract, 0 mg caffeine) |
Who may qualify
- Ages
- 16 to 28 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (6 listed)
- Smoking
- Cardiovascular diseases
- Diabetes or other metabolic disease • Hypertension (>140/>90 mm Hg)
- Presence of injuries
- Major illnesses or surgery in prior 90 days
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BeverageFree from added carbohydrates (contain 1g CHO only) and electrolytes are absent. | Other | Coffeeberry beverage, Color and flavor matched beverage |
Primary outcome
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.
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.
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.
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.
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.
11 secondary outcomes
Blood analyte: Chlorogenic acid (CGA)
Time frame: 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)
Blood analyte: Glucose
Time frame: 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)
Rating of perceived exertion (RPE)
Time frame: 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)
Mental energy
Time frame: 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)
Gut comfort
Time frame: 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)
Hydration status
Time frame: Pre-dose baseline and end of match (3.5 hours)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stuart Galloway, PhD principal investigator
U. Stirling, Scotland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Beverage in people with Skill Performance and Soccer Performance, run by PepsiCo Global R&D at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Mar 2023.