NCT06489587

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.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
1mo left

Started Jun 2024

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress97%
Jun 2024Jun 2026

First Submitted

Initial submission to the registry

June 25, 2024

Completed
Same day until next milestone

Study Start

First participant enrolled

June 25, 2024

Completed
13 days until next milestone

First Posted

Study publicly available on registry

July 8, 2024

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2025

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2026

Expected
Last Updated

July 8, 2024

Status Verified

July 1, 2024

Enrollment Period

11 months

First QC Date

June 25, 2024

Last Update Submit

July 3, 2024

Conditions

Exercise Performance

Outcome Measures

Primary Outcomes (1)

  • Peak power

    Peak power is measured in watts.

    Change from baseline to 3 days

Secondary Outcomes (5)

  • Body Weight

    Change from baseline to 3 days

  • Relative peak power

    Change from baseline to 3 days

  • Mean power

    Change from baseline to 3 days

  • Relative mean power

    Change from baseline to 3 days

  • Fatigue index

    Change from baseline to 3 days

Study Arms (2)

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

PlaceboDIETARY_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
CreatineDIETARY_SUPPLEMENT

Participants given 40 grams of creatine in total to be taken over 2 days, in 5-gram servings (4 capsules), 4 times per day.

Creatine Supplementation

Eligibility Criteria

Age18 Years - 40 Years
Sexall(Gender-based eligibility)
Gender Eligibility DetailsGender criteria are: * Cisgender man (non transgender) * Cisgender woman (non transgender) * Transgender man * Transgender woman
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

California Polytechnic State University

San Luis Obispo, California, 93407, United States

RECRUITING

MeSH Terms

Interventions

Creatine

Intervention Hierarchy (Ancestors)

GuanidinesAmidinesOrganic ChemicalsAmino AcidsAmino Acids, Peptides, and Proteins

Study Officials

  • Todd Hagobian, PhD

    California Polytechnic State University-San Luis Obispo

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Todd Hagobian, PhD

CONTACT

8057567511thagobia@calpoly.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Research staff collecting data will be masked to intervention
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Randomized study to two arms: 1) creatine supplementation, 2) glucose supplementation
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chair and Professor

Study Record Dates

First Submitted

June 25, 2024

First Posted

July 8, 2024

Study Start

June 25, 2024

Primary Completion

June 1, 2025

Study Completion (Estimated)

June 1, 2026

Last Updated

July 8, 2024

Record last verified: 2024-07

Data Sharing

IPD Sharing
Will share

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.

Shared Documents
STUDY PROTOCOL, SAP, 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.
More information

Locations

US(1)