Creatine Supplementation At Simulated Altitude | NCT06489587

Studies
Creatine Supplementation At Simulated Altitude

NCT06489587

Sponsor

California Polytechnic State University-San Luis Obispo

Status

Recruiting

Last Update Posted

Jul 8, 2024Actual

Enrollment

60Estimated

Phase

Not Applicable

Conditions

Exercise Performance

Interventions

Placebo
Creatine

Countries

United States

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

Large Document Module

Document Has No Statistical Analysis Plan (SAP)

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2024

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 25, 2024Actual

Primary Completion Date

Jun 2025Estimated

Completion Date

Jun 2026Estimated

First Submitted Date

Jun 25, 2024

First Submission Date that Met QC Criteria

Jul 3, 2024

First Posted Date

Jul 8, 2024Actual

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 3, 2024

Last Update Posted Date

Jul 8, 2024Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Todd Hagobian, Chair and Professor, California Polytechnic State University-San Luis ObispoPrincipal Investigator

Lead Sponsor

California Polytechnic State University-San Luis ObispoOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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

Creatine supplementation has been shown to increase exercise performance at sea level. The goal of this study is to determine the effects of creatine supplementation on exercise performance at simulated altitude.

Detailed Description

Military personnel often encounter harsh environments such as high altitudes and hypoxic conditions, leading to significant constraints on their exercise capacity and performance. At sea-level creatine supplementation increases exercise performance; however no experimental studies have examined the effect of creatine supplementation at simulated altitude. The overall objective of this study is to investigate the effects of creatine supplementation on exercise performance, via a repeated sprints test (Wingate Test) after a 2-day supplementation period, compared to a placebo group.

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

60Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Placebo Supplementation	Active Comparator	Participants given Placebo (20 grams of glucose) daily in 5-gram servings (4 capsules), 4 times per day for 2 days.	Dietary Supplement: Placebo
Creatine Supplementation	Experimental	Participants given Creatine (20 grams of glucose) daily in 5-gram servings (4 capsules), 4 times per day for 2 days.	Dietary Supplement: Creatine

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Placebo	Dietary Supplement	Participants given 40 grams of glucose in total to be taken over 2 days, in 5-gram servings (4 capsules), 4 times per day.	Placebo Supplementation

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Peak power	Peak power is measured in watts.	Change from baseline to 3 days

Secondary Outcomes

Measure	Description	Time Frame
Body Weight	Body weight is measured in kilograms.	Change from baseline to 3 days
Relative peak power	Relative peak power is measured in watts per kilogram.

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

18-40 years old
BMI 18.5 to 40 kg/m2
Habitually active (>150 minutes per week of moderate-vigorous physical activity)

Exclusion Criteria:

Pregnant or trying to become pregnant
Recent use of creatine supplementation
Supplemental allergies

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Yes

Sex/Gender Description

Gender criteria are:

Cisgender man (non transgender)
Cisgender woman (non transgender)
Transgender man
Transgender woman

Minimum Age

18 Years

Maximum Age

40 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Todd Hagobian, PhD	Contact	8057567511		thagobia@calpoly.edu

Overall Officials

Name	Affiliation	Role
Todd Hagobian, PhD	California Polytechnic State University-San Luis Obispo	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
California Polytechnic State University	Recruiting	San Luis Obispo	California	93407	United States

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

Data and documentation will be available under a data-sharing agreement. Information shared with outside collaborators will link data to two unique study identifiers (de-Identified) to maintain participant anonymity, and outside researchers and the community will not be allowed to have access to participant names and confidential information.

Types

Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)

Time Frame

Seven years after the date of the last participant completing the study.

Access Criteria

Contact PI and a date-sharing agreement will be created that provides for (1) a commitment to use the data for research purposes only; (2) a commitment to securing the data using appropriate computer technology (password protected and encrypted); (3) a commitment to destroying or returning the data after analyses are completed and (4) a commitment not to attempt to identify participants individually.

URL

http://healthresearch.calpoly.edu/

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Jan 26, 2024	Jul 3, 2024	Prot_000.pdf

Intervention Browse Module

MeSH Terms

ID	Term
D003401	Creatine

Ancestor Terms

ID	Term
D006146	Guanidines
D000578	Amidines
D009930	Organic Chemicals
D000596	Amino Acids

Browse Leaves

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Browse Branches

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