Effects of Magnesium Oil Application on the Muscle Contra... | NCT05339308

Studies
Effects of Magnesium Oil Application on the Muscle Contractile Properties

NCT05339308

Sponsor

University of Ljubljana

Status

Completed

Last Update Posted

Nov 18, 2024Actual

Enrollment

18Actual

Phase

Not Applicable

Conditions

Magnesium
Skeletal Muscle Contraction Properties

Interventions

Magnesium oil (BetterYou) dermal application
Placebo Control

Countries

Czechia
Slovenia

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

Nov 2024

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

May 1, 2022Actual

Primary Completion Date

Aug 1, 2022Actual

Completion Date

Sep 1, 2022Actual

First Submitted Date

Apr 14, 2022

First Submission Date that Met QC Criteria

Apr 14, 2022

First Posted Date

Apr 21, 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

Nov 14, 2024

Last Update Posted Date

Nov 18, 2024Actual

Name	Class
Masaryk University	OTHER

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

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This study will aim to investigate the effects of magnesium oil administration on skeletal muscle contractile properties.

Detailed Description

Aim: This study will aim to investigate the effects of magnesium oil administration on skeletal muscle contractile properties (SMcp).

Design: Randomized controlled study

Participants: For this purpose, investigators will recruit 40 recreationally active and healthy adults of both sexes (18-35 years of age).

Methods: The experimental leg (EXP) will receive the 10 sprays of magnesium oil (20 mg per spray) that will be topically applied to the skin covering the knee extensor muscles, whereas the control leg (CON) will receive 10 sprays of natural mineral-free oil. The vastus lateralis SMcp will be measured by using a tensiomyography (TMG) device before application (PRE) and after 10 (POST10), 20 (POST20), 30 (POST30), 40 (POST40), and 50 (POST50) minutes of application onset, respectively.

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

18Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Experimental	Experimental	Magnesium oil application	Other: Magnesium oil (BetterYou) dermal application
Control	Placebo Comparator	Natural mineral-free oil application	Other: Placebo Control

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Magnesium oil (BetterYou) dermal application	Other	10 sprays (200 mg) of magnesium oil (BetterYou) will be applied to skin covering knee extensor muscles. The magnesium oil will be applied only once

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Skeletal Muscle Contractile Properties	Skeletal muscle contractile properties will be measured by using tensiomyography device	75 minutes

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

healthy, recreationally active adults, no history of neuromuscular and musculoskeletal diseases

Exclusion Criteria:

if some of the criteria are not met

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

35 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Armin Paravlic, PhD	Faculty of Sport	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Masaryk University		Brno			Czechia
Faculty of Sport

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

Intervention Browse Module

MeSH Terms

ID	Term
D008274	Magnesium

Ancestor Terms

ID	Term
D008673	Metals, Alkaline Earth
D004602	Elements
D007287	Inorganic Chemicals
D019565	Metals, Light

Browse Leaves

Not provided

Browse Branches

Not provided

Masking Info

Masking

Triple

Masking Description

The participants will not be informed about the actual study purpose, while the main investigator will be blinded to the EXP or CON oil administration

Who Masked

ParticipantInvestigatorOutcomes Assessor