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

Trial Summary

What is the purpose of this trial?

The primary purpose is to compare the effects of creatine supplementation (bolus ingestion of 5 grams vs. 3 grams) during 16 weeks of resistance-band training on measures of body composition (i.e., whole-body lean tissue mass, total body water), arm and leg muscle thickness (growth), muscle performance (i.e., power, strength, endurance) and functional ability (i.e., walking speed, balance). A secondary purpose of this research is to examine the effects of bolus ingestion of creatine (5 grams) compared to intermittent ingestion of creatine (2 x 2.5 grams) during 16 weeks of resistance-band training on measures of body composition (i.e., whole-body lean tissue mass, total body water), arm and leg muscle thickness (growth), muscle performance (i.e., power, strength, endurance) and functional ability (i.e., walking speed, balance).

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.

What data supports the effectiveness of the treatment 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 strength in patients with neuromuscular diseases. This suggests that creatine supplementation may be beneficial for aging individuals engaging in resistance-band training. ^{1 2 3 4 5}

Is creatine supplementation safe for humans?

Creatine supplementation, particularly creatine monohydrate, is generally considered safe for healthy adults when taken at recommended doses (3 grams per day). Some people may experience mild side effects like stomach upset or muscle cramps, but serious adverse effects are rare. Studies have shown no significant risk of serious health issues, including in females, when creatine is used appropriately. ^{6 7 8 9 10}

How is the creatine treatment for aging different from other treatments?

The creatine treatment for aging is unique because it combines creatine supplementation with resistance-band training to enhance muscle strength and body composition in older adults. This approach leverages creatine's ability to improve muscle performance during high-intensity exercises, making it particularly effective for older individuals looking to maintain or increase muscle mass and strength. ^{1 4 9 11 12}

Research Team

Darren Candow

Principal Investigator

University of Regina

Eligibility Criteria

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

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

I am 50 years old or older.

Exclusion Criteria

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

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

Timeline

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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 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]

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]

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]

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]

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 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 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 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 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]

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]

References

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

Creatine supplementation enhances isometric strength and body composition improvements following strength exercise training in older adults. [2019]

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

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

3. United States 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. [2022]

4. England pubmed.ncbi.nlm.nih.gov

Effects of creatine monohydrate ingestion in sedentary and weight-trained older adults. [2013]

5. Turkey pubmed.ncbi.nlm.nih.gov

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

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

Creatine supplementation and health variables: a retrospective study. [2019]

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

Risk of Adverse Outcomes in Females Taking Oral Creatine Monohydrate: A Systematic Review and Meta-Analysis. [2021]

8. Netherlands pubmed.ncbi.nlm.nih.gov

Risk assessment for creatine monohydrate. [2013]

9. Germany pubmed.ncbi.nlm.nih.gov

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

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

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

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

Creatine supplementation. [2016]

12. Switzerland 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. [2022]