NCT05547204

Brief Summary

This study of soccer skill performance has three objectives:

  1. 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. 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 30, 2022

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

September 13, 2022

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 21, 2022

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 4, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 4, 2022

Completed
Last Updated

March 16, 2023

Status Verified

March 1, 2023

Enrollment Period

5 months

First QC Date

September 13, 2022

Last Update Submit

March 15, 2023

Conditions

Keywords

coffeeberrycaffeinepolyphenolschlorogenic acidexercisesoccerfootballskillperformance

Outcome Measures

Primary Outcomes (5)

  • 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

  • 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

  • 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.

  • 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

  • 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 Outcomes (11)

  • Blood analyte: Chlorogenic acid (CGA)

    Pre-dose baseline, 60 minutes post-dose, half-time, and end of match (3.5 hours)

  • Blood analyte: Caffeine metabolites

    Pre-dose baseline, 60 minutes post-dose, half-time, and end of match (3.5 hours)

  • Blood analyte: Glucose

    Pre-dose baseline, 60 minutes post-dose, half-time, and end of match (3.5 hours)

  • Blood analyte: Lactate

    Pre-dose baseline, 60 minutes post-dose, half-time, and end of match (3.5 hours)

  • Rating of perceived exertion (RPE)

    Half-time and end of match (3.5 hours)

  • +6 more secondary outcomes

Study Arms (2)

Coffeeberry beverage

EXPERIMENTAL

300 ml drink containing 300 mg coffeeberry extract

Other: Beverage

Color and flavor matched beverage

PLACEBO COMPARATOR

300 ml drink (0 mg coffeeberry extract, 0 mg caffeine)

Other: Beverage

Interventions

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

Coffeeberry beverageColor and flavor matched beverage

Eligibility Criteria

Age16 Years - 28 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

U. Stirling, Health Science and Sport

Stirling, Scotland, FK9 4LA, United Kingdom

Location

MeSH Terms

Conditions

Motor Activity

Interventions

Beverages

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Diet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Officials

  • Stuart Galloway, PhD

    U. Stirling, Scotland

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 13, 2022

First Posted

September 21, 2022

Study Start

June 30, 2022

Primary Completion

December 4, 2022

Study Completion

December 4, 2022

Last Updated

March 16, 2023

Record last verified: 2023-03

Data Sharing

IPD Sharing
Will not share

Locations