NCT05404841

Brief Summary

Caffeine is a widely used efficacious supplement by both the general public, and athletes, with the goal of improving performance. The effects of caffeine alone are well known, but it is not clear whether a multi-ingredient supplement (containing both caffeine and polyphenols) can affect exercise performance. This study aims to determine if a low dose of caffeine, in the form of a whole-fruit coffee extract also containing polyphenols, can improve exercise performance compared to a placebo condition, with a secondary objective of identifying if this supplement can improve post exercise refuelling (glycogen resynthesis). Participants will consume either the supplement or a placebo before engaging in an exercise protocol. Muscle biopsies will then be obtained so as to measure subsequent glycogen resynthesis, with multiple blood samples being taken through the day. The following morning another biopsy will be taken before the exercise protocol will be repeated. This research will inform us of the efficacy of caffeine and polyphenols on improving exercise performance.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
14

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2022

Geographic Reach
1 country

2 active sites

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 10, 2022

Completed
25 days until next milestone

Study Start

First participant enrolled

February 4, 2022

Completed
4 months until next milestone

First Posted

Study publicly available on registry

June 3, 2022

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 25, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 25, 2023

Completed
Last Updated

March 22, 2023

Status Verified

March 1, 2023

Enrollment Period

12 months

First QC Date

January 10, 2022

Last Update Submit

March 21, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • Exercise performance

    Amount of work completed in 15 minutes

    15 Minitues

Secondary Outcomes (6)

  • Glycogen Resynthesis

    24 Hours

  • Alertness

    1 Minitue

  • Motivation

    1 Minitue

  • Rate of perceived exertion

    1 Minitue

  • Urine osmolarity

    24 Hours

  • +1 more secondary outcomes

Study Arms (2)

CoffeeBerry Supplement

EXPERIMENTAL

Caffeine and polyphenol supplement

Dietary Supplement: CoffeeBerry Supplement

Placebo

PLACEBO COMPARATOR

Placebo

Dietary Supplement: Placebo

Interventions

CoffeeBerry SupplementDIETARY_SUPPLEMENT

A Coffeeberry supplement containing 200mg Caffeine and 14mg polyphenols, manufactured by FutureCeuticals Inc.,

CoffeeBerry Supplement
PlaceboDIETARY_SUPPLEMENT

Placebo

Placebo

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may not qualify if:

  • Allergy to Lidocaine
  • Any diagnosed metabolic health condition
  • Pregnant
  • Non-habitual caffeine intake
  • Smoker
  • No endurance training
  • Diagnosed Cardiovascular disease
  • Beta-Blockers
  • Recent history of musculoskeletal injury
  • Age 18-40
  • Heathy
  • Highly trained endurance athletes (V̇O2max: males \>55 and females \>50 mL⋅kg bm-1⋅min-1)
  • Both males and females are allowed to participate. If females are on the oral contraceptive pill they are to be tested on consecutive weeks. If they are not on the oral contraceptive pill, then female subjects are to be tested every 4 weeks, at the same point of their menstrual cycle.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Sport & Health Sciences University of Exeter

Exeter, Devon, EX1 2LU, United Kingdom

Location

University of Exeter

Exeter, EX1 2LU, United Kingdom

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 10, 2022

First Posted

June 3, 2022

Study Start

February 4, 2022

Primary Completion

January 25, 2023

Study Completion

January 25, 2023

Last Updated

March 22, 2023

Record last verified: 2023-03

Data Sharing

IPD Sharing
Will not share

Locations