Does a Multi-ingredient Pre-workout Supplement Enhance Cy... | NCT05230862

Studies
Does a Multi-ingredient Pre-workout Supplement Enhance Cycling Time Trial Performance?

NCT05230862

Sponsor

University of Exeter

Status

Completed

Last Update Posted

Jul 31, 2025Actual

Enrollment

12Actual

Phase

Not Applicable

Conditions

Healthy Volunteers

Interventions

Ladder 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

Jul 2025

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

Dec 2, 2021Actual

Primary Completion Date

Aug 31, 2022Actual

Completion Date

Sep 30, 2022Actual

First Submitted Date

Jan 10, 2022

First Submission Date that Met QC Criteria

Jan 27, 2022

First Posted Date

Feb 9, 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

Jul 28, 2025

Last Update Posted Date

Jul 31, 2025Actual

Name	Class
OpenFit LLC	UNKNOWN

Oversight Module

Has Data Monitoring Committee (DMC)

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

The aim of the present study is to test the effect of ingesting a multi-ingredient pre- exercise supplement containing caffeine, creatine, beta-alanine and L-Citrulline compared to a placebo, on endurance exercise 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

12Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Ladder Supplement	Experimental	Ladder Supplement	Dietary Supplement: Ladder Supplement
Placebo	Placebo Comparator	Placebo	Dietary Supplement: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Ladder Supplement	Dietary Supplement	Caffeine 200mg L-Theanine 200mg L-Citrulline 6g Creatine 5g Beta-Alanine 1.6g Phosphatidylserine 100mg	Ladder Supplement

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Exercise Performance	Work done during 15 min time trial (TT)	15 Minitues

Secondary Outcomes

Measure	Description	Time Frame
Alertness	Visual analog scale	1 Hour
Motivation	Visual analog scale	1 Hour

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Exclusion criteria:

Any diagnosed metabolic health condition
Pregnant
Non-habitual caffeine intake
Smoker
No endurance training
Diagnosed Cardiovascular disease
Recent history of musculoskeletal injury
Anti-depressant and anti-anxiety medication

Inclusion criteria

Age 18-40
Healthy
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.

Accepts Healthy Volunteers

Yes

Sex

All

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
School of Sport and Health Sciences		Exeter		EX4	United Kingdom