Creatine and Resistance-Band Training for Aging

Overseen By Darren Candow

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Regina

Disqualifiers: Creatine supplements, Allergies to placebo

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 aims to evaluate how different methods of taking creatine, combined with resistance-band training, affect muscle growth and performance in older adults. Participants will either take a higher dose of creatine all at once or smaller doses throughout the day, with results compared to those taking a placebo. Suitable candidates for this trial are individuals aged 50 or older who have not engaged in regular resistance training recently. As an unphased trial, this study provides participants the opportunity to explore new methods for enhancing muscle growth and performance.

Will I have to stop taking my current medications?

The trial does not specify whether you need to stop taking your current medications. However, you cannot have taken creatine supplements within 30 days before the study starts.

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

Research shows that creatine supplements are safe for use. Studies have found that the FDA considers creatine monohydrate safe for consumption. When taken orally at recommended amounts, creatine does not harm the kidneys, muscles, or the body's temperature regulation.

Creatine also supports healthy aging and has been shown to be safe for up to five years. Whether taken all at once or in smaller doses throughout the day, studies have not linked creatine to serious side effects.

Overall, creatine is generally well-tolerated, making it a promising choice for improving muscle and body function. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about these treatments because they combine creatine supplementation with resistance-band training to potentially enhance muscle strength and function in aging individuals. Unlike traditional methods that might rely solely on exercise or nutritional changes, these approaches integrate specific creatine dosing strategies—Creatine Bolus 3, Creatine Bolus 5, and Creatine Intermittent 5—with resistance training. This combination could offer a more targeted approach to improving muscle health. Creatine is known for its role in energy production in muscles, and these dosing strategies may maximize its effectiveness when paired with resistance exercises, offering a novel way to combat age-related muscle decline.

What evidence suggests that this trial's treatments could be effective for improving body composition and muscle performance in aging individuals?

This trial will compare different creatine supplementation strategies for aging adults. Research has shown that taking creatine while engaging in strength training can help older adults gain more muscle and strength. Specifically, individuals using creatine have gained about 1.4 kg more lean muscle than those who do not. It also aids in important abilities like walking faster and maintaining balance, which are crucial for healthy aging. Studies suggest that creatine can improve bone health and might help prevent falls. Whether taken all at once or split into two smaller doses during the day, creatine appears to support a healthier, more active aging process. Participants in this trial will receive either a creatine bolus, intermittent dosing, or a placebo to evaluate these effects. ^{1 4 6 7 8}

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 healthy older adults interested in improving body composition, muscle growth, and performance through resistance-band training. Participants will also be taking creatine supplements or a placebo during the study.

Inclusion Criteria

I am 50 years old or older.

Not performing more than 1 resistance training session per week for the past 6 weeks or more.

Exclusion Criteria

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

I have not taken creatine supplements 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 16 weeks of resistance-band training with creatine supplementation

16 weeks

Regular visits for training sessions

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Creatine Bolus 3
• Creatine Bolus 5
• Creatine Intermittent 5

Trial Overview The study tests if taking different amounts of creatine (3 grams vs. 5 grams) affects muscle and functional improvements from resistance-band training over 16 weeks. It also compares daily creatine intake with intermittent dosing on these health measures.

How Is the Trial Designed?

Group I: Creatine Intermittent 5 Experimental Treatment 1 Intervention

Group II: Creatine Bolus 5 Experimental Treatment 1 Intervention

Group III: Creatine Bolus 3 Experimental Treatment 1 Intervention

Group IV: Placebo Placebo Group 1 Intervention

Creatine Bolus 3 is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Creatine Monohydrate for:

• Dietary supplement for muscle strength and endurance

Approved in European Union as Creatine Monohydrate for:

• Food supplement for sports performance and muscle function

Approved in Canada as Creatine Monohydrate for:

• Natural health product for muscle strength and endurance

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

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]

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]

In a study of 28 older adults participating in a 14-week resistance exercise program, creatine monohydrate (CrM) supplementation significantly enhanced increases in fat-free mass and total body mass compared to a placebo.

CrM supplementation also led to greater improvements in isometric knee extension strength in both men and women, and in isometric dorsiflexion strength in men, with no significant side effects reported, indicating its safety and efficacy as an adjunct to resistance training.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Creatine supplementation enhances isometric strength and body composition improvements following strength exercise training in older adults. Brose, A., Parise, G., Tarnopolsky, MA.[2019]

Creatine monohydrate effectively enhances muscle performance during short-duration, high-intensity exercises, with a recommended loading dose of 0.3 g·kg·d for 5 to 7 days followed by a maintenance dose of 0.03 g·kg·d for 4 to 6 weeks, although loading is not strictly necessary.

Creatine is generally safe with few side effects, primarily causing transient water retention; however, there are concerns about potential liver and kidney complications when taken in high doses or combined with other supplements over extended periods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Creatine supplementation. Hall, M., Trojian, TH.[2016]

In a study involving 32 older adults (ages 67-80), oral creatine supplementation did not lead to significant improvements in body composition or strength when combined with an 8-week strength training program.

The results indicated that while strength training alone improved performance in exercises, adding creatine supplementation did not provide any additional benefits for strength or endurance in healthy elderly individuals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of creatine monohydrate ingestion in sedentary and weight-trained older adults. Bermon, S., Venembre, P., Sachet, C., et al.[2013]

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]

A study involving 26 athletes showed that long-term creatine supplementation (up to 4 years) did not lead to significant adverse health effects, with all health markers remaining within normal clinical ranges.

There were no reported increases in muscle injuries, cramps, or other side effects among athletes, suggesting that creatine is safe for long-term use in sports training.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Creatine supplementation and health variables: a retrospective study. Schilling, BK., Stone, MH., Utter, A., et al.[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]

Creatyl-l-leucine, a proposed dietary supplement, was tested in rats and found to not increase levels of creatine or creatyl-l-leucine in tissues, indicating it may not be a bioavailable source of creatine.

In contrast to creatine monohydrate, which is known to enhance athletic performance, creatyl-l-leucine did not show any bioaccumulation, suggesting it may not be effective as a creatine supplement.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Dietary Supplement Creatyl-l-Leucine Does Not Bioaccumulate in Muscle, Brain or Plasma and Is Not a Significant Bioavailable Source of Creatine. da Silva, RP.[2022]

Creatine monohydrate (CrM) supplementation significantly improved lower-limb Abalakov jump power and scoring performance in 23 male under-16 basketball players over an 8-week strength and conditioning program.

While CrM enhanced some performance metrics, it did not show significant effects on squat jump, drop jump, or countermovement jump performance, indicating that its benefits may be specific to certain types of power output.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomized open-labeled study to examine the effects of creatine monohydrate and combined training on jump and scoring performance in young basketball players. Vargas-Molina, S., García-Sillero, M., Kreider, RB., et al.[2022]

Creatine monohydrate supplementation has been shown to significantly improve maximal power, strength, and performance in high-intensity exercises, making it beneficial for athletes engaged in activities requiring short bursts of effort.

While creatine is generally safe at recommended doses and poses no serious health risks, it does not enhance performance in endurance activities like running and swimming.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Creatine supplementation and exercise performance: a brief review. Bird, SP.[2021]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11649744/

The power of creatine plus resistance training for healthy aging Creatine supplementation during resistance training results in ∼1.4 kg greater increase in lean tissue mass when compared to placebo. This translates to ...

2. tandfonline.com tandfonline.com/doi/full/10.1080/15502783.2025.2534130

Creatine monohydrate supplementation for older adults ... In addition to resistance training, there is a growing body of evidence which shows that CrM also provides muscle and functionality benefits to older adults.

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12272710/

Creatine monohydrate supplementation for older adults and ... 4. Creatine supplementation and aging bone, Falls and frailty. CrM during resistance training programs have some potential to improve bone ...

4. withpower.com withpower.com/trial/phase-aging-7-2024-117ab

Creatine and Resistance-Band Training for Aging Research shows that creatine monohydrate can enhance strength and muscle mass in older adults when combined with resistance exercise, as well as improve ...

5. eurapa.biomedcentral.com eurapa.biomedcentral.com/articles/10.1186/s11556-025-00384-9

Impact of creatine supplementation and exercise training in ... Creatine supplementation has physiological benefits in older adults, primarily enhancing muscle strength, lean mass, and functional capacity [13] ...

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

Creatine Safety and side effects. When used orally at appropriate doses, creatine is likely safe to take for up to five years. As with any dietary supplement, it's ...

7. frontiersin.org frontiersin.org/journals/nutrition/articles/10.3389/fnut.2025.1578564/full

Creatine supplementation is safe, beneficial throughout the ... High-quality creatine monohydrate is Generally Recognized as Safe (GRAS) by the Food and Drug Administration (13) and is considered safe for human consumption ...

8. 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 ... Based on clinical trial data, there is no evidence that ingesting creatine supplements at recommended doses impairs renal, muscular or thermoregulatory ...