Creatine for Strength Training

Overseen By Darren Candow

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: University of Regina

Must not be taking: Creatine

Disqualifiers: Pregnancy, Nursing, Allergies, others

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

Compensation: Varies

Number of Visits: 21

Duration: 3 weeks

42 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to evaluate how different methods of creatine intake (a supplement often used to enhance strength training) affect muscle growth and performance. Participants will receive creatine either in a single dose or in smaller doses throughout the day, while some will take a placebo (a harmless pill with no active ingredient) for comparison. The trial will measure changes in muscle mass, body water, and muscle strength. Ideal participants are those who have not engaged in weight training for at least four weeks and have not used creatine recently. As an unphased trial, this study provides participants the opportunity to contribute to foundational research on creatine supplementation and its effects.

Do I need to stop taking my current medications for the trial?

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

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that creatine is generally safe for most people. Studies have found that creatine supplements can boost muscle strength and aid recovery after exercise. They might also help prevent injuries and assist in healing. Although creatine is not one of the essential amino acids, it provides energy to muscles, which can be useful for activities requiring quick bursts of power, like sprinting or weightlifting.

Most people using creatine do not experience serious side effects, though some might notice minor issues like bloating or an upset stomach. Research over the years supports its safety when used as directed. Those considering joining a trial or taking creatine should consult a healthcare provider, especially if there are existing health concerns. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about using creatine for strength training because it focuses on enhancing muscle energy levels, unlike most supplements that just provide nutrients. Creatine is unique because it directly supplies the muscles with a quick source of energy, potentially leading to faster strength gains. The trial explores different dosing methods: intermittent dosing involves smaller, consistent creatine doses, while the bolus approach uses a larger dose once a day. By comparing these methods, scientists hope to find the most effective way to boost muscle power and improve training results.

What evidence suggests that this trial's treatments could be effective for improving muscle mass and performance?

Research has shown that creatine can strengthen muscles and enhance performance. One study found that participants using creatine could lift up to 45% more weight in a bench press. Another study revealed that creatine users gained more muscle strength compared to those taking a placebo, a substance with no active ingredients. Regular creatine use also increased upper-body strength by about 2.8% and lower-body strength by 7.3%. Additionally, creatine helped individuals gain muscle and power without adding body fat. This trial will compare different creatine dosing strategies, including intermittent and bolus dosing, against a placebo to evaluate its effectiveness in boosting muscle growth and performance. ^{6 7 8 9 10}

Who Is on the Research Team?

Darren Candow

Principal Investigator

University of Regina

Are You a Good Fit for This Trial?

This trial is for young, healthy adults who are participating in strength training. Specific eligibility details aren't provided, but typically participants should not have health conditions that could be affected by creatine or interfere with the study.

Inclusion Criteria

Not performing resistance training for at least 4 weeks prior to the start of the study

Exclusion Criteria

Pre-existing allergies to the placebo (corn-starch maltodextrin)

Pregnant or nursing

I have not taken creatine monohydrate in the last 30 days.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive creatine supplementation or placebo for 21 days to assess effects on body composition and muscle performance

3 weeks

Baseline and day 21 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Creatine

Trial Overview The study is testing how taking creatine affects body composition and muscle performance during strength training. It compares a single dose of 5 grams to two doses totaling 5 grams against a placebo over three weeks.

How Is the Trial Designed?

Group I: Creatine Intermittent Experimental Treatment 1 Intervention

(Serving 1: 2.5 grams of creatine monohydrate + 5.5 grams of placebo in the morning; Serving 2: 2.5 grams of creatine monohydrate + 5.5 grams of placebo in the evening) for 21 days.

Group II: Creatine Bolus Experimental Treatment 1 Intervention

(Serving 1: 5 grams of creatine monohydrate + 3 grams of placebo in the morning; Serving 2: 8 grams of placebo in the evening) for 21 days.

Group III: Placebo Placebo Group 1 Intervention

(Servings 1: 8 grams of placebo in the morning; Serving 2: 8 grams of placebo in the evening) for 21 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?

University of Regina

Lead Sponsor

Trials

59

Recruited

9,100+

Iovate Health Sciences International Inc

Industry Sponsor

Trials

10

Recruited

350+

Published Research Related to This Trial

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]

The novel creatine blend CN-CRN significantly increased serum creatine levels more than both pure creatine nitrate and regular creatine monohydrate in a study of 10 healthy young men, indicating superior bioavailability.

After 5 days of supplementation, CN-CRN also led to a greater increase in muscle creatine levels compared to the other formulations, while showing no clinically relevant side effects, suggesting it is a safe and effective alternative to traditional creatine supplements.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Searching for a better formulation to enhance muscle bioenergetics: A randomized controlled trial of creatine nitrate plus creatinine vs. creatine nitrate vs. creatine monohydrate in healthy men. Ostojic, SM., Stajer, V., Vranes, M., et al.[2023]

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 supplementation, when combined with resistance training, leads to an average increase in muscle strength of 8% more than placebo, highlighting its efficacy as a training aid for athletes.

The review of 22 studies shows that creatine supplementation also improves weightlifting performance by an average of 14% compared to placebo, indicating its potential to enhance athletic performance significantly.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of creatine supplementation and resistance training on muscle strength and weightlifting performance. Rawson, ES., Volek, JS.[2019]

In a pilot study with 81 patients and a follow-up study with 21 patients, creatine monohydrate supplementation significantly increased strength measures, including handgrip and knee extensor strength.

The treatment involved administering 10 g daily for 5 days, followed by 5 g daily for another 5 days, demonstrating that short-term creatine use can effectively enhance high-intensity strength in individuals with neuromuscular disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Creatine monohydrate increases strength in patients with neuromuscular disease. Tarnopolsky, M., Martin, J.[2019]

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 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]

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]

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]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/14636102/

Effects of creatine supplementation and resistance training ... The increase in bench press 1RM ranged from 3 to 45%, and the improvement in weightlifting performance in the bench press ranged from 16 to 43%. Thus there is ...

2. mdpi.com mdpi.com/2072-6643/16/21/3665

Effects of Creatine Supplementation and Resistance ... Collectively, the results have shown that creatine supplementation leads to greater improvements in muscle strength compared with a placebo.

3. frontiersin.org frontiersin.org/journals/sports-and-active-living/articles/10.3389/fspor.2022.1033842/full

Effects of creatine monohydrate timing on resistance ... In this regard, main effects over time were observed, which illustrated improvements in upper- (2.8%) and lower-body strength (7.3%), as well as ...

4. jissn.biomedcentral.com jissn.biomedcentral.com/articles/10.1186/s12970-021-00412-w

Common questions and misconceptions about creatine ... Creatine supplementation reduced the frequency of symptomatic muscle cramping by 60% [79]. These beneficial effects from creatine may be ...

5. journals.lww.com journals.lww.com/nsca-jscr/abstract/1999/08000/long_term_effects_of_creatine_monohydrate_on.1.aspx

Long-Term Effects of Creatine Monohydrate on Strength ... Results revealed the creatine monohydrate group was able to significantly increase measures of strength and power and increase body mass without a change in ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5469049/

safety and efficacy of creatine supplementation in exercise ... Research has shown that creatine supplementation may enhance post-exercise recovery, injury prevention, thermoregulation, rehabilitation, and concussion and/or ...

7. health.harvard.edu health.harvard.edu/exercise-and-fitness/what-is-creatine-potential-benefits-and-risks-of-this-popular-supplement

What is creatine? Potential benefits and risks of this ... Are creatine supplements safe? Answer: Creatine is often called an amino acid. But technically it is not one of the 20 amino acids that are the ...

8. mayoclinic.org mayoclinic.org/drugs-supplements-creatine/art-20347591

Creatine Generally safe. Creatine might benefit athletes who need short bursts of speed or increased muscle strength, such as sprinters, weight lifters and team sport ...

9. gssiweb.org gssiweb.org/en/sports-science-exchange/Article/the-safety-and-efficacy-of-creatine-monohydrate-supplementation-what-we-have-learned-from-the-past-25-years-of-research

THE SAFETY AND EFFICACY OF CREATINE ... Creatine monohydrate supplementation enhances a variety of factors and processes involved in adaptation to exercise, including increased gene/ growth factor ...

10. my.clevelandclinic.org my.clevelandclinic.org/health/treatments/17674-creatine

Creatine: What It Does, Benefits, Supplements & Safety Creatine is a natural source of energy that helps your skeletal muscles flex (contract). It helps create a steady supply of energy in your muscles so they can ...