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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04181619
Other study ID # PEP-1904
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date November 6, 2019
Est. completion date August 3, 2021

Study information

Verified date March 2022
Source PepsiCo Global R&D
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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).


Recruitment information / eligibility

Status Completed
Enrollment 30
Est. completion date August 3, 2021
Est. primary completion date August 3, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
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 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 Design


Related Conditions & MeSH terms


Intervention

Dietary Supplement:
Coffeeberry beverage
One exposure of 300 mg coffeeberry extract in a 300 ml flavored still beverage prior to exercise session
Other:
Comparator beverage
One 300 ml still beverage, color and flavor matched to experimental beverage prior to exercise session

Locations

Country Name City State
United Kingdom University of 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
Other Blood analyte concentration: Capillary glucose (mmol/L), more regulated would be better During 3.5 hours post consumption
Other Blood analyte concentration: Capillary lactate (mmol/L), lower (delayed rise) would be better During 3.5 hours post consumption
Other Blood analyte concentration: Serum chlorogenic acid (mmol/L), n.a. for placebo, introduced to evaluate primary outcomes During 3.5 hours post consumption
Other Blood analyte concentration: Serum caffeine (ug/mL), n.a. for placebo, Introduced to evaluate primary outcomes During 3.5 hours post consumption
Other Rate of Perceived Exertion (RPE) By Borg scale, rated 6-20, lower values would be better During 3.5 hours post consumption
Other Activation/Deactivation (feelings and mood) 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
Other Mental energy By Visual Analog Scale (VAS) vertical marking on 100 mm horizontal line, higher energy would be better During 3.5 hours post consumption
Other Physical energy By Visual Analog Scale (VAS) vertical marking on 100 mm horizontal line, higher energy would be better During 3.5 hours post consumption
Other Heart rate By electronic reading, lower would be better During 3.5 hours post consumption
Other Gut comfort 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
Other Hydration status Urine osmolality in mOsm/kg, comparing pre- vs. post-exercise concentration During 3.5 hours post consumption
Primary Dribbling speed m/sec, increase would be better. Simulated match in an indoor gym with pre-set targets. During 3.5 hours post consumption
Primary Dribbling precision Meters, more accuracy would be better. Simulated match in an indoor gym against pre-set targets. During 3.5 hours post consumption
Primary Passing accuracy 1-10 scale, higher score would be better. Simulated match in an indoor gym against pre-set targets. During 3.5 hours post consumption
Primary Passing speed by Time km/h, increased would be better. Simulated match in an indoor gym against pre-set targets. During 3.5 hours post consumption
Primary Shooting accuracy More shots on target would be better. Simulated match in an indoor gym against pre-set targets. During 3.5 hours post consumption
Primary Shooting speed Milliseconds, faster would be better. Simulated match in an indoor gym against pre-set targets. During 3.5 hours post consumption
Secondary Sprint speed m/sec, increase would be better. In indoor gym with marked course. During 3.5 hours post consumption
Secondary High-intensity endurance running capacity Run time to volitional fatigue in min, increase would be better. In indoor gym with marked course. During 3.5 hours post consumption
See also
  Status Clinical Trial Phase
Completed NCT03348267 - Protein Supplementation and Muscle Recovery in Football N/A
Completed NCT05547204 - Impact of Coffeeberry Extract on Skill Performance During Simulated Match Play in Academy Football Players N/A