NCT05641454

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 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

October 17, 2022

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

November 1, 2022

Completed
1 month until next milestone

First Posted

Study publicly available on registry

December 7, 2022

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 15, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 15, 2023

Completed
Last Updated

March 22, 2023

Status Verified

March 1, 2023

Enrollment Period

4 months

First QC Date

November 1, 2022

Last Update Submit

March 21, 2023

Conditions

Caffeine and Endurance Performance

Outcome Measures

Primary Outcomes (1)

  • Muscle ATP concentration

    Concentration of ATP in skeletal muscle tissue (mmol/kg dry weight)

    4 hours

Secondary Outcomes (10)

  • Total work performed during exercise

    2 hours

  • Blood ATP concentration

    4 hours

  • Substrate oxidation

    1 hour

  • Blood glucose concentration

    4 hours

  • Blood lactate concentration

    4 hours

  • +5 more secondary outcomes

Study Arms (2)

ElevATP supplement

EXPERIMENTAL
Dietary Supplement: ElevATP supplement

Maltodextrin placebo

PLACEBO COMPARATOR
Dietary Supplement: Placebo

Interventions

ElevATP supplementDIETARY_SUPPLEMENT

ElevATP supplement containing apple and ancient peat extract

ElevATP supplement
PlaceboDIETARY_SUPPLEMENT

Maltodextrin placebo

Maltodextrin placebo

Eligibility Criteria

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

You may qualify if:

  • 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.)

You may not qualify if:

  • Allergy to Lidocaine
  • Any diagnosed metabolic health condition
  • Pregnant
  • Non-habitual caffeine intake
  • Smoker
  • Diagnosed Cardiovascular disease
  • Beta-Blockers
  • Recent history of musculoskeletal injury

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Exeter

Exeter, Devon, EX1 2LU, United Kingdom

Location

Study Design

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

Study Record Dates

First Submitted

November 1, 2022

First Posted

December 7, 2022

Study Start

October 17, 2022

Primary Completion

February 15, 2023

Study Completion

February 15, 2023

Last Updated

March 22, 2023

Record last verified: 2023-03

Data Sharing

IPD Sharing
Will not share

Locations

GB(1)