Creatine Supplementation for Muscle Strength

Overseen By Darren Candow

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: University of Regina

Disqualifiers: Pregnant, Nursing, Creatine use, others

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 16 weeks

52 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how creatine, a popular supplement, can enhance muscle strength and performance when combined with regular resistance training. Researchers aim to determine the optimal timing for creatine intake—before, after, or on non-training days—to maximize muscle gain. Participants will be divided into groups to test these timings against a placebo (a harmless pill with no active ingredients). Those who have engaged in structured resistance training more than twice a week for at least four weeks may find this trial suitable. As an unphased trial, it offers a unique opportunity to contribute to understanding optimal creatine use for muscle enhancement.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, you should avoid creatine supplements for 30 days before the study.

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

Research has shown that creatine monohydrate is generally safe for use. Studies have found it is usually well tolerated and rarely causes serious side effects. Although some people worry about potential kidney or muscle problems, research has found no evidence of harm when creatine is used correctly.

Creatine may also help reduce muscle cramps and injuries. While the FDA doesn't regulate supplements as strictly as prescription drugs, many people have used creatine without major issues. Always follow the recommended dosage. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about creatine supplementation for muscle strength because it offers a unique approach compared to typical options like resistance training and protein supplements. Creatine monohydrate, the active ingredient in this treatment, is known for its potential to enhance muscle energy production and strength by increasing phosphocreatine stores in muscles. Unlike standard supplements that mainly provide protein for muscle repair, creatine specifically targets energy availability, which can lead to improved performance during high-intensity exercise. Additionally, this trial explores the timing of creatine intake—before training, after training, or on non-training days—to determine the most effective strategy for maximizing muscle strength gains.

What evidence suggests that this trial's treatments could be effective for muscle strength?

This trial will evaluate the effects of creatine supplementation on muscle strength. Studies have shown that creatine can improve muscle strength and performance. Research indicates that it increases levels of a substance in muscles important for quick energy during exercise, leading to faster energy production and better exercise performance. Many studies have found that creatine results in greater strength and muscle growth, especially when combined with weight training. Creatine is also known to be safe and can help reduce muscle cramps. Overall, creatine is widely recognized as effective for boosting muscle strength and exercise performance. Participants in this trial will be assigned to different arms to assess the timing of creatine supplementation relative to training sessions. ^{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 adults aged 18-39 who are physically active, doing structured resistance training at least twice a week for the past month. It's not suitable for those pregnant, nursing, or with recent creatine use.

Inclusion Criteria

Physically active (performing structured resistance training > 2x/week for ≥ 4 weeks)

Exclusion Criteria

Pre-existing allergies to the placebo

Pregnant or nursing

I have taken creatine monohydrate in the last 30 days.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo resistance training with creatine supplementation or placebo for 16 weeks

16 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Creatine Monohydrate

Trial Overview

The study tests whether taking creatine monohydrate improves muscle strength and growth more than a placebo during resistance training. The goal is to find the best way to take creatine for maximum benefits.

How Is the Trial Designed?

Group I: Creatine Non-Training Experimental Treatment 2 Interventions

5 grams of creatine monohydrate + 3 grams of placebo on non-training days; 8 grams of placebo immediately before training sessions; 8 grams of placebo immediately after training sessions.

Group II: Creatine Before Training Experimental Treatment 2 Interventions

5 grams of creatine monohydrate + 3 grams of placebo immediately before training sessions; 8 grams of placebo immediately after training sessions; 8 grams of placebo on non-training days.

Group III: Creatine After Training Experimental Treatment 2 Interventions

5 grams of creatine monohydrate + 3 grams of placebo immediately after training sessions; 8 grams of placebo immediately before training sessions; 8 grams of placebo on non-training days.

Group IV: Placebo Placebo Group 1 Intervention

8 grams of placebo immediately before training sessions; 8 grams of placebo immediately after training sessions; 8 grams of placebo on non-training days

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

Approved in United States as Creatine Monohydrate for:

• Dietary supplement for general health and wellness

Approved in European Union as Creatine Monohydrate for:

• Dietary supplement for general health and wellness

Approved in Canada as Creatine Monohydrate for:

• Dietary supplement for general health and wellness

Who Is Running the Clinical Trial?

University of Regina

Lead Sponsor

Trials

59

Recruited

9,100+

Published Research Related to This Trial

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]

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]

In a study involving 29 healthy participants over 14 days, creatine monohydrate supplementation significantly increased muscle creatine content, demonstrating its effectiveness in enhancing muscle performance.

Conversely, creatyl-L-leucine (CLL) did not result in any changes in muscle creatine levels, indicating that it may not be an effective alternative to creatine monohydrate for improving muscle performance.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Creatine Monohydrate Supplementation, but not Creatyl-L-Leucine, Increased Muscle Creatine Content in Healthy Young Adults: A Double-Blind Randomized Controlled Trial. Askow, AT., Paulussen, KJM., McKenna, CF., et al.[2023]

A study involving six healthy males showed that after a single oral dose of creatine (71 mg/kg), the clearance rate was 0.20 L/h/kg, with peak concentration reached at about 1.9 hours.

After six days of repeated dosing, the clearance rate decreased to 0.12 L/h/kg, indicating that the body may become saturated with creatine in the muscles, which could affect how the body processes it.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Single- and multiple-dose pharmacokinetics of oral creatine. Persky, AM., Müller, M., Derendorf, H., et al.[2019]

A systematic review of 29 studies involving 951 female participants found no serious adverse outcomes or deaths associated with creatine monohydrate (CrM) supplementation, indicating it is safe for use in women.

There were no significant differences in total adverse events, gastrointestinal issues, or weight gain between those taking CrM and those not, suggesting that CrM does not increase the risk of these complications in females.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Risk of Adverse Outcomes in Females Taking Oral Creatine Monohydrate: A Systematic Review and Meta-Analysis. de Guingand, DL., Palmer, KR., Snow, RJ., et al.[2021]

In a study involving 34 adult patients with myotonic muscular dystrophy type 1 (DM1), creatine monohydrate (CrM) supplementation at 5 g daily did not improve muscle strength, body composition, or daily activities over a 4-month period.

The lack of effectiveness may be due to CrM not increasing muscle phosphocreatine (PCr) levels, which are important for muscle energy, as no significant changes were observed in muscle PCr/beta-ATP ratios.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Creatine monohydrate supplementation does not increase muscle strength, lean body mass, or muscle phosphocreatine in patients with myotonic dystrophy type 1. Tarnopolsky, M., Mahoney, D., Thompson, T., et al.[2013]

In a 3-month double-blind trial involving 20 patients with myotonic dystrophy type 2, creatine monohydrate did not show significant improvements in muscle strength compared to placebo, as measured by various strength assessments.

However, there were some trends suggesting mild improvements with creatine, and two patients reported relief from myalgia, indicating potential benefits that may warrant further investigation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Creatine monohydrate in DM2/PROMM: a double-blind placebo-controlled clinical study. Proximal myotonic myopathy. Schneider-Gold, C., Beck, M., Wessig, C., et al.[2019]

Creatine supplementation can enhance performance in high-intensity, short-duration exercises, but it is not effective for endurance sports, based on a review of various studies.

While generally well tolerated in short-term use, creatine may cause side effects like weight gain, cramping, and potential renal function decrease, highlighting the need for caution due to variability in product quality and dosing.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Creatine: a review of efficacy and safety. Graham, AS., Hatton, RC.[2013]

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]

Oral creatine supplementation can lead to weight gain due to water retention, which might negatively affect performance in activities that rely on body mass, like running and swimming.

Short-term use of creatine (less than 28 days) at recommended doses appears safe based on limited studies, but these studies had small sample sizes and did not adequately explore potential effects on key organs like the heart and brain, highlighting the need for larger, more comprehensive trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Potential side effects of oral creatine supplementation: a critical review. Juhn, MS., Tarnopolsky, M.[2019]

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]

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