- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05641454
The Effect of a Peat and Apple Extract on Muscle ATP and Exercise Performance (APEX)
March 21, 2023 updated by: University of Exeter
A study to test the hypothesis that a combined peat and apple extract will increase blood and muscle ATP, which will increase cycling performance
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
10
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Devon
-
Exeter, Devon, United Kingdom, EX1 2LU
- University of Exeter
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 40 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Male
Description
Inclusion Criteria:
- Age 18 - 40
- Healthy
- Recreationally active (i.e. Participants will be deemed as too trained if they are defined as participating in structured resistance exercise 3 or more times per week for >6 months or participating in structured endurance exercise for >6h per week for >6 months. Participants will be defined as too sedentary if they do not exceed the governments guidelines of 150 / 75 min per week of light / heavy exercise.)
Exclusion Criteria:
- Allergy to Lidocaine
- Any diagnosed metabolic health condition
- Pregnant
- Non-habitual caffeine intake
- Smoker
- Diagnosed Cardiovascular disease
- Beta-Blockers
- Recent history of musculoskeletal injury
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: ElevATP supplement
|
ElevATP supplement containing apple and ancient peat extract
|
Placebo Comparator: Maltodextrin placebo
|
Maltodextrin placebo
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Muscle ATP concentration
Time Frame: 4 hours
|
Concentration of ATP in skeletal muscle tissue (mmol/kg dry weight)
|
4 hours
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Total work performed during exercise
Time Frame: 2 hours
|
Work performed during glycogen depleting exercise on a cycle ergometer (J)
|
2 hours
|
Blood ATP concentration
Time Frame: 4 hours
|
Concentration of ATP in blood (mmol/L)
|
4 hours
|
Substrate oxidation
Time Frame: 1 hour
|
Substrate oxidation over 1 h steady state cycle (g/min)
|
1 hour
|
Blood glucose concentration
Time Frame: 4 hours
|
Concentration of glucose in blood (mmol/L)
|
4 hours
|
Blood lactate concentration
Time Frame: 4 hours
|
Concentration of lactate in blood (mmol/L)
|
4 hours
|
Muscle glycogen
Time Frame: 4 hours
|
Muscle glycogen concentration in skeletal muscle tissue (mmol/kg dry weight)
|
4 hours
|
Muscle ADP concentration
Time Frame: 4 hours (mmol/kg dry weight)
|
Concentration of muscle metabolites
|
4 hours (mmol/kg dry weight)
|
Muscle ATP concentration
Time Frame: 4 hours (mmol/kg dry weight)
|
Concentration of muscle metabolites
|
4 hours (mmol/kg dry weight)
|
Muscle creatine concentration
Time Frame: 4 hours (mmol/kg dry weight)
|
Concentration of muscle metabolites
|
4 hours (mmol/kg dry weight)
|
Muscle phosphocreatine concentration
Time Frame: 4 hours (mmol/kg dry weight)
|
Concentration of muscle metabolites
|
4 hours (mmol/kg dry weight)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 17, 2022
Primary Completion (Actual)
February 15, 2023
Study Completion (Actual)
February 15, 2023
Study Registration Dates
First Submitted
November 1, 2022
First Submitted That Met QC Criteria
November 30, 2022
First Posted (Actual)
December 7, 2022
Study Record Updates
Last Update Posted (Actual)
March 22, 2023
Last Update Submitted That Met QC Criteria
March 21, 2023
Last Verified
March 1, 2023
More Information
Terms related to this study
Other Study ID Numbers
- 516252
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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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