Creatine Supplementation At Simulated Altitude

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.

Study Overview

• Status: Recruiting
• Conditions: Exercise Performance
• Intervention / Treatment: Dietary supplement: Placebo; Dietary supplement: Creatine

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.

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Todd Hagobian, PhD; Phone Number: 8057567511; Email: thagobia@calpoly.edu

Study Locations

• United States
  • California
    • San Luis Obispo, California, United States, 93407
      • Recruiting
      • California Polytechnic State University
      • Contact: Todd Hagobian, PhD; Phone Number: 805-756-7511; Email: thagobia@calpoly.edu
      • Contact: Eric Benso, BS; Phone Number: 805-756-7525; Email: ecbenson@calpoly.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Placebo Supplementation; Participants given Placebo (20 grams of glucose) daily in 5-gram servings (4 capsules), 4 times per day for 2 days.	Dietary supplement: Placebo; Participants given 40 grams of glucose in total to be taken over 2 days, in 5-gram servings (4 capsules), 4 times per day.
Experimental: Creatine Supplementation; Participants given Creatine (20 grams of glucose) daily in 5-gram servings (4 capsules), 4 times per day for 2 days.	Dietary supplement: Creatine; Participants given 40 grams of creatine in total to be taken over 2 days, in 5-gram servings (4 capsules), 4 times per day.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	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.	Change from baseline to 3 days
Mean power	Mean power is measured in watts.	Change from baseline to 3 days
Relative mean power	Relative mean power is measured in watts per kilogram.	Change from baseline to 3 days
Fatigue index	Fatigue index is measured in watts per second.	Change from baseline to 3 days

Collaborators and Investigators

• Sponsor: California Polytechnic State University-San Luis Obispo
• Investigators: Principal Investigator: Todd Hagobian, PhD, California Polytechnic State University-San Luis Obispo

Study record dates

Study Major Dates

• Study Start (Actual): June 25, 2024
• Primary Completion (Estimated): June 1, 2025
• Study Completion (Estimated): June 1, 2026

Study Registration Dates

• First Submitted: June 25, 2024
• First Submitted That Met QC Criteria: July 3, 2024
• First Posted (Actual): July 8, 2024

Study Record Updates

• Last Update Posted (Actual): July 8, 2024
• Last Update Submitted That Met QC Criteria: July 3, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: 2023-233

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan 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.
• IPD Sharing Time Frame: Seven years after the date of the last participant completing the study.
• IPD Sharing 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No