- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05404841
Investigating the Effect of Whole-fruit Coffee Extract on Exercise Performance (PACE)
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Exeter, United Kingdom, EX1 2LU
- University of Exeter
-
-
Devon
-
Exeter, Devon, United Kingdom, EX1 2LU
- Sport & Health Sciences University of Exeter
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Exclusion criteria:
- Allergy to Lidocaine
- Exclusion critera
- Any diagnosed metabolic health condition
- Pregnant
- Non-habitual caffeine intake
- Smoker
- No endurance training
- Diagnosed Cardiovascular disease
- Beta-Blockers
- Recent history of musculoskeletal injury
Inclusion criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Placebo Comparator: Placebo
|
Placebo
|
|
Experimental: CoffeeBerry Supplement
Caffeine and polyphenol supplement
|
A Coffeeberry supplement containing 200mg Caffeine and 14mg polyphenols, manufactured by FutureCeuticals Inc.,
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Exercise performance
Time Frame: 15 Minitues
|
Amount of work completed in 15 minutes
|
15 Minitues
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Glycogen Resynthesis
Time Frame: 24 Hours
|
The diffrence in glycogen within the muscle between two time points
|
24 Hours
|
|
Alertness
Time Frame: 1 Minitue
|
10 cm visual analog scale (Ranging from Not Alert to Extremly Alert)
|
1 Minitue
|
|
Motivation
Time Frame: 1 Minitue
|
10 cm visual analog scale (Ranging from Not motivated to Extremly motivated)
|
1 Minitue
|
|
Rate of perceived exertion
Time Frame: 1 Minitue
|
Validated Borg scale (6-20 Arbitrary units)
|
1 Minitue
|
|
Urine osmolarity
Time Frame: 24 Hours
|
The hydration status of the individual measured in mOsmo|/kg
|
24 Hours
|
|
GI comfort
Time Frame: 1 Minitue
|
10 cm visual analog scale (Ranging from No discomfort to Extreme discomfort)
|
1 Minitue
|
Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 2021-10-20-B-05
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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