Development of Biomarkers for Monitoring Menopause in Women
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age20+
SponsorFu Jen Catholic University Hospital
About this trial
This cross-sectional study aims to develop and validate mitochondrial biomarkers for monitoring menopause in women. The study will involve 100 participants divided into three groups: reproductive period, perimenopausal transition period, and postmenopausal period. Peripheral blood samples will be collected, and mitochondrial quality and quantity will be assessed using both qualitative and quantitative analyses. The study will identify potential biomarkers through metabolomics and validate them for monitoring the perimenopausal transition, providing a novel approach for women's health management during menopause.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Biological female, age order than 20 years old.
Disqualifiers
Person with cancer.
Person with any known acute or chronic infection.
Person with known chronic illness under follow up or treatment.
Pregnancy, one year withing delivery, under breast feeding, or three months within breast feeding.
Trial population
Study Population Description: The study population consists of adult women aged over 20 years old, categorized into three groups: reproductive period (ages 20-45, regular menstrual cycles) perimenopausal transition period (ages 45-50, experiencing menstrual irregularities) postmenopausal period (ages over 50, no menstrual period for at least one year). All participants must be in general good health, without major chronic diseases, infection, or pregnancy.
Trial design
Design model
Cohort
Time perspective
Cross-sectional
Treatments tested in this trial
Blood Sample Collection
Other interventionCollection of peripheral blood samples for mitochondrial analysis, including the extraction of mononuclear cells and plasma for further assessment of mitochondrial quality and quantity.
Treatment groups
100 Participants
are divided into 3 treatment groupsGroup A: Reproductive Period1 intervention
Group B: Perimenopausal Transition Period1 intervention
Group C: Postmenopausal Period1 intervention
Trial outcomes
Primary outcomes
1
Mitochondrial Quantitative Analysis
This outcome measure involves evaluating mitochondrial energy metabolism, including ATP content, oxygen consumption rate (OCR), and extracellular acidification rate (ECAR) using a hippocampal metabolic analyzer. Additionally, mitochondrial membrane potential will be assessed using flow cytometry to analyze the distribution of JC-1, indicating mitochondrial health. Digital PCR will be employed to measure mitochondrial DNA copy numbers, determining mitochondrial mass and comparing differences between groups.
Time frame
12 months from study start2
Mitochondrial Qualitative Analysis
This measure assesses mitochondrial protein markers using Western blot analysis. PCNA will be used as a nuclear protein marker, while cytochrome c and HSP60 will be used as mitochondrial protein markers to evaluate mitochondrial quality
Time frame
12 months from study start3
Validation of Candidate Biomarkers
This outcome measure focuses on the validation of high-confidence protein markers identified through RNA-Seq and LC-MS/MS data. The validation will be conducted using customized protein databases and further experiments to confirm the feasibility of these candidate biomarkers for monitoring perimenopausal transition.
Time frame
12 months from study startSponsors and contacts
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Source ClinicalTrials.gov