Resistance Training + Creatine for Perimenopause

(PERIHIRT Trial)

Overseen By Abbie Smith-Ryan, PhD

Age: 18 - 65

Sex: Female

Trial Phase: Academic

Sponsor: University of North Carolina, Chapel Hill

Must not be taking: Diuretics, Corticosteroids

Disqualifiers: Kidney disease, Liver disease, COPD, Cancer, others

Compensation: Varies

Number of Visits: 3

Duration: 6 weeks

51 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how high-intensity resistance training (HIRT), with or without creatine, affects muscle strength, brain health, and metabolism in women experiencing perimenopause. Participants will take either creatine monohydrate, a placebo, or no supplement, with some also engaging in resistance training. It suits perimenopausal women who are moderately active but do not regularly engage in intense strength training and have health conditions like type 2 diabetes or high blood pressure that could benefit from exercise.

As an unphased trial, this study provides a unique opportunity to enhance understanding of the benefits of exercise and supplements during perimenopause.

Will I have to stop taking my current medications?

The trial requires that you stop taking certain medications, like diuretics and corticosteroids, as they may affect the study's main outcomes. If you're using creatine or other performance supplements, you'll also need to stop those.

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

Previous studies have shown creatine monohydrate to be safe for women, with no serious side effects reported. Research has found no risk of major health problems or death linked to creatine use in women. This aligns with earlier reviews that found creatine safe for both men and women. Although limited information exists on women going through menopause, women before menopause have successfully used creatine to improve strength and exercise performance. Overall, creatine is well-tolerated and does not pose major health risks for women. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about combining creatine monohydrate with resistance training for perimenopause because it offers a unique approach to improving muscle health and energy levels. Unlike hormone replacement therapy or lifestyle changes, this treatment uses creatine, a compound naturally found in muscles, to potentially enhance physical performance and muscle strength. The addition of high-intensity resistance training twice a week aims to further boost these benefits, providing a non-hormonal option that could be effective in just a few days. This novel combination may offer a quicker and more direct impact on muscle health compared to traditional methods.

What evidence suggests that this trial's treatments could be effective for perimenopausal women?

This trial will compare the effects of creatine monohydrate with a placebo in perimenopausal women. Studies have shown that creatine monohydrate, especially when combined with high-intensity resistance training, increases muscle strength and improves exercise performance in women. Research indicates it enhances muscle quality, strength, and bone health in post-menopausal women. A recent review of multiple studies found that creatine led to greater improvements in muscle mass and overall physical function. Although data on perimenopausal women is limited, creatine is believed to offer similar benefits based on its known effects in other groups. These findings suggest that creatine, along with resistance training, could be a promising option for improving muscle and bone health in perimenopausal women. ^{2 3 4 6 7}

Who Is on the Research Team?

Abbie Smith-Ryan, PhD

Principal Investigator

University of North Carollina at Chapel Hill

Are You a Good Fit for This Trial?

This trial is for healthy perimenopausal women aged 38-60. Participants will be randomly assigned to one of three groups: creatine with high-intensity resistance training (HIRT), placebo with HIRT, or no supplement and no training.

Inclusion Criteria

Recreationally active (≥30 minutes of moderate-intensity physical activity per week and <3 times per week of progressive resistance training)

I am going through perimenopause and have symptoms or am on hormone therapy.

Body mass index of 18.5-34.9 kg/m^2

Exclusion Criteria

I've had a recent injury that stops me from joining the study.

I have chronic kidney disease, liver disease, COPD, or cancer.

Currently pregnant or planning to become pregnant (determined from urine pregnancy test)

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Supplementation

Participants undergo a 5-day supplementation phase with either creatine monohydrate or placebo

1 week

1 visit (in-person)

Treatment

Participants engage in high-intensity resistance training with or without creatine supplementation

6 weeks

2 visits per week (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 Monohydrate
• Placebo

Trial Overview The study aims to compare the effects of high-intensity resistance training combined with either creatine monohydrate supplementation or a placebo on muscle characteristics, brain health, and metabolism in perimenopausal women.

How Is the Trial Designed?

Group I: Creatine Monohydrate Experimental Treatment 1 Intervention

20 g Creatine Monohydrate for 5 days followed by 5 grams creatine monohdyrate daily + 2 x weekly high intensity resistance training

Group II: Control Active Control 1 Intervention

No exercise or supplement provided

Group III: Placebo Placebo Group 1 Intervention

20 g Non-Caloric Placebo followed by 5 grams daily placebo + 2 x weekly high intensity resistance training

Who Is Running the Clinical Trial?

University of North Carolina, Chapel Hill

Lead Sponsor

Trials

1,588

Recruited

4,364,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7998865/

Creatine Supplementation in Women's Health: A Lifespan ... Creatine supplementation among pre-menopausal females appears to be effective for improving strength and exercise performance.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT07027800

High Intensity Resistance Training + Creatine in ... Outcomes will include assessments of muscle quality and strength, cognitive function, brain oxygenation, metabolic rate, and protein turnover, while accounting ...

3. tandfonline.com tandfonline.com/doi/full/10.1080/15502783.2025.2502094

Full article: Creatine in women's health: bridging the gap ... More recently, creatine use in post-menopausal women has demonstrated a positive impact on bone health and strength [77], with the longest 2-year randomized ...

4. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40371844/

Creatine in women's health: bridging the gap from ... Emerging evidence suggests creatine's benefits during pregnancy and post-menopause, though data on perimenopausal women remains limited.

5. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0531556515300206

Effects of long-term low-dose dietary creatine ... A recent meta-analysis showed that creatine supplementation induced greater increases in fat-free mass, upper and lower-body strength, and physical function ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7353222/

Risk of Adverse Outcomes in Females Taking Oral ... We found no mortality or serious adverse events associated with CrM supplementation in females, which agrees with previous safety reviews in male or mixed sex ...

7. researchgate.net researchgate.net/publication/342192793_Risk_of_Adverse_Outcomes_in_Females_Taking_Oral_Creatine_Monohydrate_A_Systematic_Review_and_Meta-Analysis

(PDF) Risk of Adverse Outcomes in Females Taking Oral ... In conclusion, mortality and serious adverse events are not associated with CrM supplementation in females. Nor does the use of creatine ...