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

NCT07286136 — Not applicable, Completed, 60 participants, FLO LIVING, LLC

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Registry	NCT07286136
Status	Completed
Phase	Not applicable
Study type	Interventional; na, single group, masking: none, treatment
Enrollment	60 (Actual)
Sponsor	FLO LIVING, LLC (Industry); collaborators: Citruslabs
Conditions	Menstrual Cycle Disorder, Menstrual Symptoms, Hormonal Imbalance
Interventions	MyFLO App (Dietary supplement)
Dates	start 2025-05-01, primary completion 2025-10-01, completion 2025-10-01, first posted 2025-12-16, last updated 2025-12-16
Locations	1 site in United States

-Summary

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.

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+Arms and interventions

Arm	Type	Interventions	Description
Cycle SyncingⓇ Intervention Group	Experimental	Dietary Supplement: MyFLO App	Participants will follow the Cycle SyncingⓇ Method daily for 12 weeks using the MyFLO app.

MyFLO App (Dietary 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.

+Outcome measures

Primary outcomes

Change in Cycle Symptom Burden [Baseline, Month 1, Month 2, and Month 3]: Change in total symptom burden and severity scores as measured by validated symptom questionnaires.

Secondary outcomes

Time to Improvement in Symptom Burden [Baseline, Month 1, Month 2, and Month 3]: Time to statistically significant improvement in symptom burden, based on monthly assessments using validated questionnaires.
Change in Luteinizing Hormone (LH) levels [Baseline, Month 1, Month 2, Month 3]: Evaluation of changes in LH levels measured via the MIRA urine device.
Variations in Basal Body Temperature (BBT) [Baseline, Month 1, Month 2, Month 3]: 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.
Impact on Blood Glucose Levels [Baseline, Month 1, Month 2, Month 3]: Assessment of blood glucose trends throughout the study, with a focus on changes during the luteal phase of the menstrual cycle.
Change in Estrone-3-glucuronide (E3G) levels [Baseline, Month 1, Month 2, Month 3]: Evaluation of changes in E3G levels measured via the MIRA urine device.
Change in Pregnanediol Glucuronide (PdG) levels [Baseline, Month 1, Month 2, Month 3]: Evaluation of changes in PdG levels measured via the MIRA urine device.
Change in Follicle-Stimulating Hormone (FSH) levels [Baseline, Month 1, Month 2, Month 3]: Evaluation of changes in FSH levels measured via the MIRA urine device.

+Eligibility

Sex: Female, ages: 22 Years to 42 Years, accepts healthy volunteers

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)

Facility	City	Country	Status
Citruslabs	Las Vegas, Nevada	United States

My Notes

Public

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