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

Trial Summary

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.

What data supports the idea that Creatine for Strength Training is an effective treatment?

The available research shows that creatine monohydrate is effective in increasing muscle creatine content and improving performance in high-intensity exercises. It is particularly beneficial for activities that require short bursts of energy, like jumping, sprinting, or cycling. Compared to other forms of creatine, creatine monohydrate consistently enhances exercise performance. While some studies suggest that newer formulations like creatine nitrate mixed with creatinine might increase creatine levels more effectively, creatine monohydrate remains a reliable and widely used option for improving strength and performance. ^{1 2 3 4 5}

What safety data exists for creatine used in strength training?

Creatine monohydrate (CrM) is widely recognized as safe for use in dietary supplements, with a recommended daily intake of 3 grams unlikely to pose safety concerns for healthy adults. Some adverse effects like gastrointestinal complaints and muscle cramps have been reported. CrM has substantial evidence supporting its bioavailability, efficacy, and safety, and is recommended by professional societies. Other forms of creatine, such as creatine nitrate and creatine orotate, have limited safety data and may pose some safety concerns. Novel forms like creatine nitrate mixed with creatinine (CN-CRN) have shown increased bioavailability and are considered relatively safe, though more research is needed to confirm long-term safety. ^{2 4 6 7 8}

Is creatine a promising treatment for strength training?

Yes, creatine is a promising treatment for strength training. Studies show that when combined with resistance training, creatine can increase muscle strength by an average of 8% more than training alone. It also improves weightlifting performance by 14% more than without it. Creatine monohydrate is the most effective and safe form, widely recognized for its benefits in boosting strength and performance. ^{3 4 7 9 10}

What is the purpose of this trial?

The purpose is to compare the effects of bolus ingestion (5 grams) vs. intermittent ingestion (2 x 2.5 grams) of creatine supplementation vs. placebo for 21 days on measures of body composition (lean tissue mass-indicator of muscle mass, total body water) and muscle performance (i.e., power, strength, endurance).

Research Team

Darren Candow

Principal Investigator

University of Regina

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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 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]

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 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]

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 (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 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 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]

References

1. 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]

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

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

3. Netherlands pubmed.ncbi.nlm.nih.gov

Risk assessment for creatine monohydrate. [2013]

4. United States 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. [2023]

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

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

6. Germany pubmed.ncbi.nlm.nih.gov

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

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

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

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

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

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

Effects of creatine supplementation and resistance training on muscle strength and weightlifting performance. [2019]

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

Creatine monohydrate increases strength in patients with neuromuscular disease. [2019]