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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05547204
Other study ID # PEP-2114
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date June 30, 2022
Est. completion date December 4, 2022

Study information

Verified date March 2023
Source PepsiCo Global R&D
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.


Recruitment information / eligibility

Status Completed
Enrollment 15
Est. completion date December 4, 2022
Est. primary completion date December 4, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 16 Years to 28 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
Beverage
Free from added carbohydrates (contain 1g CHO only) and electrolytes are absent.

Locations

Country Name City State
United Kingdom U. Stirling, Health Science and Sport Stirling Scotland

Sponsors (1)

Lead Sponsor Collaborator
PepsiCo Global R&D

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Dribbling speed 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
Primary Dribbling precision 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
Primary Passing accuracy 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.
Primary Passing speed 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
Primary Sprint speed. 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 Blood analyte: Chlorogenic acid (CGA) 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)
Secondary Blood analyte: Caffeine metabolites 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)
Secondary Blood analyte: Glucose 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)
Secondary Blood analyte: Lactate 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)
Secondary Rating of perceived exertion (RPE) 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)
Secondary 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. Pre-dose baseline, 60 minutes post-dose, half-time, and end of match (3.5 hours)
Secondary Mental energy 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)
Secondary Physical energy 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)
Secondary Gut comfort 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)
Secondary Heart rate By electronic reading. Lower would be better. Continuous from pre-dose baseline through end of match (3.5 hours)
Secondary Hydration status Urine osmolality in mOsm/kg change in concentration pre- vs. post-exercise Pre-dose baseline and end of match (3.5 hours)
See also
  Status Clinical Trial Phase
Completed NCT04181619 - Influence of Coffeeberry Ingestion on Soccer Skill Performance N/A
Completed NCT03348267 - Protein Supplementation and Muscle Recovery in Football N/A