The Effect of a Peat and Apple Extract on Muscle ATP and... | NCT05641454

Studies
The Effect of a Peat and Apple Extract on Muscle ATP and Exercise Performance

NCT05641454

Sponsor

University of Exeter

Status

Completed

Last Update Posted

Mar 22, 2023Actual

Enrollment

10Actual

Phase

Not Applicable

Conditions

Caffeine and Endurance Performance

Interventions

ElevATP supplement
Placebo

Countries

United Kingdom

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 17, 2022Actual

Primary Completion Date

Feb 15, 2023Actual

Completion Date

Feb 15, 2023Actual

First Submitted Date

Nov 1, 2022

First Submission Date that Met QC Criteria

Nov 30, 2022

First Posted Date

Dec 7, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 21, 2023

Last Update Posted Date

Mar 22, 2023Actual

Name	Class
VDF FutureCeuticals Inc.	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

A study to test the hypothesis that a combined peat and apple extract will increase blood and muscle ATP, which will increase cycling performance

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

10Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
ElevATP supplement	Experimental		Dietary Supplement: ElevATP supplement
Maltodextrin placebo	Placebo Comparator		Dietary Supplement: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
ElevATP supplement	Dietary Supplement	ElevATP supplement containing apple and ancient peat extract	ElevATP supplement

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Muscle ATP concentration	Concentration of ATP in skeletal muscle tissue (mmol/kg dry weight)	4 hours

Secondary Outcomes

Measure	Description	Time Frame
Total work performed during exercise	Work performed during glycogen depleting exercise on a cycle ergometer (J)	2 hours
Blood ATP concentration	Concentration of ATP in blood (mmol/L)

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

40 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Exeter		Exeter	Devon	EX1 2LU	United Kingdom

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided