High Intensity Resistance Training + Creatine in Perimenopause

NCT07027800 | Completed

• 1 other identifier: 24-3202
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 1

Brief Summary

Purpose: The aims of the study are to investigate the effects of high-intensity resistance training (HIRT) with or without creatine monohydrate (CM) supplementation on three key areas: muscle characteristics, brain health, and metabolism/protein dynamics. Participants: 51 healthy, perimenopausal women between 38-60 years old. Procedures: In a randomized double-blind, placebo-controlled design, participants will either consume creatine (CM), a placebo (PL), or no supplement (CON). CM and PL groups will be assigned a HIRT protocol, and the CON will do no training.

Conditions

Perimenopause

Keywords

resistance training; muscle mass; hormone health; creatine monohydrate; exercise; nutrition; womens health

Outcome Measures

Primary Outcomes (2)

• Muscle quality

  Muscle quality measured by echo intensity via ultrasound

  Baseline to after 6 weeks of resistance training and supplementation

• Muscle Strength

  Maximal strength from 1 repetition maximum for leg press

  Baseline to post 6 weeks of resistance training and supplementation

Secondary Outcomes (3)

• Menopausal Symptoms

  Baseline to post 6 weeks of resistance training + supplementation

• Resting metabolic rate

  Baseline to post 6 weeks of resistance training + supplementation

• Inventory of Depression and Anxiety

  Baseline to post 6 weeks of resistance training + supplementation

Study Arms (3)

Creatine Monohydrate

EXPERIMENTAL

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

Dietary Supplement: Creatine Monohydrate

Placebo

PLACEBO COMPARATOR

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

Dietary Supplement: Placebo

Control

NO INTERVENTION

No exercise or supplement provided

Interventions

Creatine Monohydrate DIETARY_SUPPLEMENT

20 gram loading of creatine monohdyrate for 5 days, followed by 5 grams per day for 6 weeks

Creatine Monohydrate

Placebo DIETARY_SUPPLEMENT

20 grams daily of non-caloric placebo + 5 grams daily non-caloric placebo for 6 weeks

Placebo

Eligibility Criteria

• Age: 38 Years - 60 Years
• Gender Eligibility Details: Female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Women transitioning through perimenopause (defined by the North American Menopause Society Menopause Health Questionnaire), with or without hormone therapy or experiencing two or more perimenopause-related symptoms, as determined from the validated North American Menopause Society
• Women ≥38-60 yrs.
• Recreationally active \[(≥30 minutes of moderate-intensity physical activity per week and \<3 times per week of progressive resistance training, as defined by the International Physical Activity Questionnaire (IPAQ)\]
• Body mass index of 18.5-34.9 kg/m\^2
• Is at risk or has a current chronic disease that is not contraindicated by exercise, and could be improved by resistance exercise (i.e. type 2 diabetes, heart disease, hypertension, hypercholesterolemia, hyperthyroidism, depression, osteoporosis, etc.)

You may not qualify if:

• Experienced a musculoskeletal injury within the past three months that inhibits participation in the study.
• Has chronic kidney disease, liver disease, chronic obstructive pulmonary disease, or cancer
• Currently using medications that may directly impact the primary outcomes including: diuretics and corticosteroids).
• Currently using creatine monohydrate or other performance-enhancing supplements
• Has a self-identified or clinically diagnosed eating disorder
• Currently pregnant or planning to become pregnant (determined from urine pregnancy test)
• Currently nursing or have had a child within the previous 6 months
• Has participated in another clinical trial within four weeks prior to enrollment that in the opinion of the PI would influence the results.
• Has severely impaired hearing or speech or inability to speak English.
• Unwilling or unable to comply with the study protocol, including abstaining from caffeine, tobacco, alcohol, and physical activity before testing days.

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead

Study Sites (1)

Applied Physiology Laboratory

Chapel Hill, North Carolina, 27713, United States

Location

MeSH Terms

Conditions

Motor Activity

Interventions

Creatine

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Guanidines; Amidines; Organic Chemicals; Amino Acids; Amino Acids, Peptides, and Proteins

Study Officials

• Abbie Smith-Ryan, PhD

  University of North Carollina at Chapel Hill

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 2, 2025
• First Posted: June 19, 2025
• Study Start: June 2, 2025
• Primary Completion: December 15, 2025
• Study Completion: December 15, 2025
• Last Updated: March 11, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)