RECRUITING

High Intensity Resistance Training + Creatine in Perimenopause

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Conditions

Perimenopauseresistance trainingmuscle masshormone healthcreatine monohydrateexercisenutritionwomens health

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Effects of High-intensity Resistance Training and Creatine Supplementation on Muscle Quality and Cognition in Perimenopausal Women: a Pilot Study

Quick Facts

Study Start:2025-06-02
Study Completion:2026-08-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT07027800

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:38 Years to 60 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:No
Standard Ages:ADULT
Inclusion CriteriaExclusion Criteria
  1. * 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
  2. * Women ≥38-60 yrs.
  3. * Recreationally active \[(≥30 minutes of moderate-intensity physical activity per week and \<3 times per week of progressive resistance training, as defined by the International Physical Activity Questionnaire (IPAQ)\]
  4. * Body mass index of 18.5-34.9 kg/m\^2
  5. * 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.)
  1. * Experienced a musculoskeletal injury within the past three months that inhibits participation in the study.
  2. * Has chronic kidney disease, liver disease, chronic obstructive pulmonary disease, or cancer
  3. * Currently using medications that may directly impact the primary outcomes including: diuretics and corticosteroids).
  4. * Currently using creatine monohydrate or other performance-enhancing supplements
  5. * Has a self-identified or clinically diagnosed eating disorder
  6. * Currently pregnant or planning to become pregnant (determined from urine pregnancy test)
  7. * Currently nursing or have had a child within the previous 6 months
  8. * Has participated in another clinical trial within four weeks prior to enrollment that in the opinion of the PI would influence the results.
  9. * Has severely impaired hearing or speech or inability to speak English.
  10. * Unwilling or unable to comply with the study protocol, including abstaining from caffeine, tobacco, alcohol, and physical activity before testing days.

Contacts and Locations

Study Contact

Abbie Smith-Ryan, PhD
CONTACT
919-962-2574
abbiesmith@unc.edu
Research Coordinator
CONTACT
919-962-2163

Principal Investigator

Abbie Smith-Ryan, PhD
PRINCIPAL_INVESTIGATOR
University of North Carollina at Chapel Hill

Study Locations (Sites)

Applied Physiology Laboratory
Chapel Hill, North Carolina, 27713
United States

Collaborators and Investigators

Sponsor: University of North Carolina, Chapel Hill

  • Abbie Smith-Ryan, PhD, PRINCIPAL_INVESTIGATOR, University of North Carollina at Chapel Hill

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-06-02
Study Completion Date2026-08-01

Study Record Updates

Study Start Date2025-06-02
Study Completion Date2026-08-01

Terms related to this study

Keywords Provided by Researchers

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

Additional Relevant MeSH Terms

  • Perimenopause