Evaluation of The Cycle SyncingⓇ Method: A 12-Week Virtual Clinical Trial

FLO LIVING, LLC60 enrolled

Overview

This 12-week, 100% virtual single-group open-label trial evaluates the Cycle SyncingⓇ Method using the MyFLO app, MIRA hormonal monitoring, and continuous glucose monitoring to assess reduction in menstrual cycle symptom burden and hormonal regulation.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Menstrual Cycle Disorder Menstrual Symptoms Hormonal Imbalance

Interventions

MyFLO AppDIETARY_SUPPLEMENT

Participants follow the Cycle SyncingⓇ Method using the MyFLO app daily for 12 weeks. This includes personalized food and workout plans, symptom logging, hormonal testing with MIRA devices (urine and BBT), continuous glucose monitoring (CGM), and weekly virtual coaching sessions.

Eligibility

Sex: FEMALEMin age: 22 YearsMax age: 42 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Female participants aged 22 - 42 years * Regular menstrual cycles * Willingness and ability to comply with daily app usage and device protocols * Access to a compatible smartphone and reliable internet connection * Ability to attend a weekly virtual call with study personnel Exclusion Criteria: * Current pregnancy or breastfeeding * Use of hormonal contraceptives or other medications known to alter menstrual cycle physiology * Presence of significant comorbidities or chronic conditions that may interfere with study participation * Any condition that, in the investigator's opinion, would make participation unsafe

Locations (1)

Citruslabs

Las Vegas, Nevada, United States

Outcomes

Primary Outcomes

Change in Cycle Symptom Burden

Change in total symptom burden and severity scores as measured by validated symptom questionnaires.

Time frame: Baseline, Month 1, Month 2, and Month 3

Secondary Outcomes

Time to Improvement in Symptom Burden

Time to statistically significant improvement in symptom burden, based on monthly assessments using validated questionnaires.

Time frame: Baseline, Month 1, Month 2, and Month 3

Change in Luteinizing Hormone (LH) levels

Evaluation of changes in LH levels measured via the MIRA urine device.

Time frame: Baseline, Month 1, Month 2, Month 3

Variations in Basal Body Temperature (BBT)

Assessment of blood glucose trends throughout the study, with a focus on changes during the luteal phase of the menstrual cycle. Data will be collected continuously via CGM and analyzed monthly.

Time frame: Baseline, Month 1, Month 2, Month 3

Impact on Blood Glucose Levels

Assessment of blood glucose trends throughout the study, with a focus on changes during the luteal phase of the menstrual cycle.

Time frame: Baseline, Month 1, Month 2, Month 3

Change in Estrone-3-glucuronide (E3G) levels

Evaluation of changes in E3G levels measured via the MIRA urine device.

Time frame: Baseline, Month 1, Month 2, Month 3

Change in Pregnanediol Glucuronide (PdG) levels

Evaluation of changes in PdG levels measured via the MIRA urine device.

Data from ClinicalTrials.gov

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