Ignite Creation Date:
2025-12-26 @ 12:14 PM
Ignite Modification Date:
2025-12-31 @ 4:42 PM
Study NCT ID:
NCT07027800
Status:
RECRUITING
Last Update Posted:
2025-06-25
First Post:
2025-06-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
High Intensity Resistance Training + Creatine in Perimenopause
Sponsor:
University of North Carolina, Chapel Hill
Organization:
Study Overview
Official Title:
Effects of High-intensity Resistance Training and Creatine Supplementation on Muscle Quality and Cognition in Perimenopausal Women: a Pilot Study
Status:
RECRUITING
Status Verified Date:
2025-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PERIHIRT
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.
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.
Detailed Description:
Over one million women in the U.S. transition through menopause each year, a phase marked by significant hormonal fluctuations (estrogen, progesterone, luteinizing hormone) and associated with increased cardiometabolic and cardiovascular risks. Research from our lab has identified key metabolic disruptions during the perimenopausal (PERI) period, including reduced protein balance, increased abdominal fat, decreased strength, and impaired metabolic flexibility. Additionally, women as early as age 35 may experience menopause-related symptoms such as cognitive decline, mood disturbances, and sleep disruptions.
Skeletal muscle health, critical for lifelong function, often begins to decline during PERI. While resistance training is known to improve muscle strength and body composition in older women, limited research has focused specifically on the PERI stage. High-intensity resistance training (HIRT) offers a time-efficient strategy to address these issues. Creatine monohydrate (CM) supplementation, traditionally used to enhance muscle performance, has shown potential benefits for cognitive function, mood, fatigue reduction, and overall metabolic health-effects particularly relevant to PERI women.
This pilot study aims to evaluate the preliminary effects of six weeks of HIRT, with or without CM supplementation, on muscle characteristics, brain health, and metabolism in women around PERI age. The study uses a randomized, double-blind, placebo-controlled design with broad inclusion criteria to enhance generalizability. Participants will undergo a 5-day supplementation phase followed by a 6-week training phase. Outcomes will include assessments of muscle quality and strength, cognitive function, brain oxygenation, metabolic rate, and protein turnover, while accounting for hormonal fluctuations.
This trial will provide foundational data to inform a larger, more comprehensive study and aims to identify effective, accessible interventions to support health and quality of life in women during the menopause transition.
Skeletal muscle health, critical for lifelong function, often begins to decline during PERI. While resistance training is known to improve muscle strength and body composition in older women, limited research has focused specifically on the PERI stage. High-intensity resistance training (HIRT) offers a time-efficient strategy to address these issues. Creatine monohydrate (CM) supplementation, traditionally used to enhance muscle performance, has shown potential benefits for cognitive function, mood, fatigue reduction, and overall metabolic health-effects particularly relevant to PERI women.
This pilot study aims to evaluate the preliminary effects of six weeks of HIRT, with or without CM supplementation, on muscle characteristics, brain health, and metabolism in women around PERI age. The study uses a randomized, double-blind, placebo-controlled design with broad inclusion criteria to enhance generalizability. Participants will undergo a 5-day supplementation phase followed by a 6-week training phase. Outcomes will include assessments of muscle quality and strength, cognitive function, brain oxygenation, metabolic rate, and protein turnover, while accounting for hormonal fluctuations.
This trial will provide foundational data to inform a larger, more comprehensive study and aims to identify effective, accessible interventions to support health and quality of life in women during the menopause transition.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: