Creatine for Exercise Performance

Overseen By Todd Hagobian, PhD

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: California Polytechnic State University-San Luis Obispo

Disqualifiers: Pregnancy, Recent creatine use, Allergies

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 2 days

60 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the treatment Creatine for exercise performance?

Research shows that creatine monohydrate can increase muscle creatine content and improve performance in high-intensity, short-duration exercises like sprinting and cycling. It is one of the most widely used supplements for enhancing athletic performance, with studies indicating it significantly impacts force production. ^{1 2 3 4 5}

Is creatine safe for human use?

Creatine monohydrate (CrM) is widely recognized as safe for use in dietary supplements, with international regulatory authorities supporting its safety. A daily intake of 3 grams is generally considered safe for healthy adults, although some people may experience minor side effects like stomach upset or muscle cramps. Other forms of creatine have less safety data available, and some may pose safety concerns. ^{1 6 7 8 9}

How does creatine differ from other treatments for exercise performance?

Creatine monohydrate is unique because it is one of the most researched supplements for improving high-intensity exercise performance, particularly in activities involving short bursts of energy like sprinting or cycling. Unlike other forms of creatine, it has a well-established loading and maintenance protocol that enhances muscle creatine content and exercise capacity without significant adverse effects. ^{1 3 4 5 10}

Research Team

Todd Hagobian, PhD

Principal Investigator

California Polytechnic State University-San Luis Obispo

Eligibility Criteria

This trial is for active individuals aged 18-40 with a BMI of 18.5 to 40 kg/m2, who exercise more than 150 minutes weekly at a moderate to vigorous level. It's not open to those who've recently used creatine supplements, are pregnant or attempting pregnancy, or have allergies to supplements.

Inclusion Criteria

Habitually active (>150 minutes per week of moderate-vigorous physical activity)

My BMI is between 18.5 and 40.

Exclusion Criteria

I have recently used creatine supplements.

Pregnant or trying to become pregnant

Supplemental allergies

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1 week

Treatment

Participants receive either creatine or placebo supplementation for 2 days

2 days

Daily visits for supplementation

Follow-up

Participants are monitored for changes in exercise performance metrics

3 days

Treatment Details

Interventions

• Creatine

Trial Overview The study aims to assess the impact of creatine on exercise performance under conditions that mimic high altitude. Participants will be randomly assigned either creatine or a placebo (a substance with no therapeutic effect) and their performance will be compared.

Participant Groups

Group I: Creatine Supplementation Experimental Treatment 1 Intervention

Participants given Creatine (20 grams of glucose) daily in 5-gram servings (4 capsules), 4 times per day for 2 days.

Group II: Placebo Supplementation Active Control 1 Intervention

Participants given Placebo (20 grams of glucose) daily in 5-gram servings (4 capsules), 4 times per day for 2 days.

Creatine is already approved in United States, European Union for the following indications:

Approved in United States as Creatine Monohydrate for:

• Dietary supplement for muscle growth and performance
• Potential treatment for post-concussive symptoms

Approved in European Union as Creatine Monohydrate for:

• Dietary supplement for muscle growth and performance
• Potential treatment for post-concussive symptoms

Who Is Running the Clinical Trial?

California Polytechnic State University-San Luis Obispo

Lead Sponsor

Trials

33

Recruited

3,400+

Findings from Research

Creatine nitrate (CrN) supplementation at 3 g was well-tolerated and showed no safety concerns, with minimal side effects reported across all treatment groups in a study involving 48 participants over 28 days.

In terms of exercise performance, the CrN-High group significantly increased bench press lifting volume compared to the placebo group, demonstrating that CrN can provide similar performance benefits to traditional creatine monohydrate (CrM).

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Acute and chronic safety and efficacy of dose dependent creatine nitrate supplementation and exercise performance. Galvan, E., Walker, DK., Simbo, SY., et al.[2018]

A 28-day study with 49 healthy young athletes showed that both creatine pyruvate (Cr-Pyr) and creatine citrate (Cr-Cit) significantly improved exercise performance during high-intensity handgrip exercises, with Cr-Pyr showing superior benefits.

Cr-Pyr not only enhanced power and contraction velocity throughout all exercise intervals but also increased relaxation velocity and oxygen consumption during rest, suggesting it may support endurance through improved aerobic metabolism.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effects of creatine pyruvate and creatine citrate on performance during high intensity exercise. Jäger, R., Metzger, J., Lautmann, K., et al.[2021]

Creatine monohydrate is effective in enhancing athletic performance, particularly for activities involving repeated short bursts of high-intensity effort, with significant improvements in force production across various sports, ages, and sexes.

While creatine shows benefits for activities like jumping, sprinting, and cycling, it does not significantly aid in preventing muscle damage or soreness, and there is limited evidence for its effectiveness in endurance activities. Additionally, no strong evidence suggests adverse effects from short-term use, but long-term safety remains unstudied.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Creatine supplementation and exercise performance: recent findings. Bemben, MG., Lamont, HS.[2022]

In a study involving 36 resistance-trained individuals, traditional creatine monohydrate (CrM) supplementation was found to be more effective than buffered creatine (KA) in increasing muscle creatine content and improving strength, with no significant differences in side effects reported between the two forms.

The results showed that neither the recommended lower dose of KA nor the higher equivalent loading dose provided any additional benefits over CrM, challenging claims that buffered creatine is superior in efficacy or safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A buffered form of creatine does not promote greater changes in muscle creatine content, body composition, or training adaptations than creatine monohydrate. Jagim, AR., Oliver, JM., Sanchez, A., et al.[2021]

Creatine monohydrate is effective for enhancing performance in high-intensity, short-duration activities, supported by a large body of research involving both acute (20 g/d) and chronic (3-5 g/d) supplementation studies.

The Observed Safe Level (OSL) for chronic creatine supplementation is established at 5 g/d, indicating strong safety evidence at this dosage, while higher intakes lack sufficient long-term safety data despite being tested without adverse effects in acute studies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Risk assessment for creatine monohydrate. Shao, A., Hathcock, JN.[2013]

Creatine nitrate (CN) supplementation at doses of 1 g and 2 g daily for 28 days was found to be safe for young adults, with no significant adverse effects on most blood safety markers.

While some participants experienced slight increases in blood urea nitrogen (BUN) levels, these changes were minor and not clinically concerning, suggesting that CN could be a viable alternative to traditional creatine monohydrate supplements.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

28 days of creatine nitrate supplementation is apparently safe in healthy individuals. Joy, JM., Lowery, RP., Falcone, PH., et al.[2018]

Creatine monohydrate (CrM) remains the only form of creatine with substantial evidence supporting its bioavailability, efficacy, and safety, as confirmed by a review of various marketed creatine forms.

Despite ongoing claims about other 'novel forms' of creatine, many lack sufficient evidence for effectiveness and safety, and CrM is still the recommended source by professional organizations and regulatory authorities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Bioavailability, Efficacy, Safety, and Regulatory Status of Creatine and Related Compounds: A Critical Review. Kreider, RB., Jäger, R., Purpura, M.[2022]

Creatine monohydrate is generally considered safe for healthy adults at a daily intake of 3 grams, with some minor side effects like gastrointestinal issues and muscle cramps reported.

While most creatine forms are unlikely to pose safety concerns, there are specific safety concerns associated with creatine orotate, creatine phosphate, and magnesium creatine chelate, indicating that not all creatine supplements are equally safe.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Creatine and creatine forms intended for sports nutrition. Andres, S., Ziegenhagen, R., Trefflich, I., et al.[2018]

Acute creatine monohydrate supplementation (20 g per day for 5 days) significantly increased fat-free mass and total body mass in both men and women, with a more pronounced effect in men.

The study found no adverse effects on blood pressure, renal function, or muscle enzyme activity, indicating that creatine is safe for use in both genders during high-intensity exercise.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Acute creatine loading increases fat-free mass, but does not affect blood pressure, plasma creatinine, or CK activity in men and women. Mihic, S., MacDonald, JR., McKenzie, S., et al.[2019]

In a study with 12 elite cyclists, creatine loading (25 g/day for 5 days) significantly improved peak and mean sprint power output by 8-9% during maximal sprints after endurance exercise, compared to a placebo.

However, ingesting creatine during the exercise test (5 g/h) negated these sprint performance benefits, indicating that while creatine loading enhances sprint capacity, its effectiveness can be diminished by concurrent intake during exercise.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of creatine loading on endurance capacity and sprint power in cyclists. Vandebuerie, F., Vanden Eynde, B., Vandenberghe, K., et al.[2022]

References

1. United States pubmed.ncbi.nlm.nih.gov

Acute and chronic safety and efficacy of dose dependent creatine nitrate supplementation and exercise performance. [2018]

2. United States pubmed.ncbi.nlm.nih.gov

The effects of creatine pyruvate and creatine citrate on performance during high intensity exercise. [2021]

3. New Zealand pubmed.ncbi.nlm.nih.gov

Creatine supplementation and exercise performance: recent findings. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

A buffered form of creatine does not promote greater changes in muscle creatine content, body composition, or training adaptations than creatine monohydrate. [2021]

5. Netherlands pubmed.ncbi.nlm.nih.gov

Risk assessment for creatine monohydrate. [2013]

6. United States pubmed.ncbi.nlm.nih.gov

28 days of creatine nitrate supplementation is apparently safe in healthy individuals. [2018]

7. Switzerland pubmed.ncbi.nlm.nih.gov

Bioavailability, Efficacy, Safety, and Regulatory Status of Creatine and Related Compounds: A Critical Review. [2022]

8. Germany pubmed.ncbi.nlm.nih.gov

Creatine and creatine forms intended for sports nutrition. [2018]

9. United States pubmed.ncbi.nlm.nih.gov

Acute creatine loading increases fat-free mass, but does not affect blood pressure, plasma creatinine, or CK activity in men and women. [2019]

10. Germany pubmed.ncbi.nlm.nih.gov

Effect of creatine loading on endurance capacity and sprint power in cyclists. [2022]