A Study to Evaluate the Effect of Funk It Cycle Bites on PMS

Not Applicable

Completed

• Conditions: Premenstrual Syndrome
• Interventions: Other: Funk It Cycle Bites

• Registration Number: NCT05900024
• Lead Sponsor: Funk It Wellness

Brief Summary

This is a virtual, open-label, single-group study that will last 4 menstrual cycles. All participants will complete a questionnaire at the end of their first period after enrolling (baseline/non-intervention cycle 1), then proceed to take the product daily and complete questionnaires at the end of their next 3 periods (intervention cycles 1, 2, and 3). The study will involve 30 female participants with regular menstrual cycles who experience PMS.

Questionnaires will be used to monitor menstrual pain/cramps, energy levels, mood, and hormonal acne experienced before and during the menstrual cycle. Likert scale responses will be statistically compared from baseline to each check-in. Participant responses on product feedback will be presented as % scores.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-05-01
• Study First Submitted: 2023-06-02
• Study First Submitted QC: 2023-06-02
• Study First Posted: 2023-06-12
• Primary Completion: 2023-09-01
• Study Completion: 2023-10-01
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-27
• Last Update Posted: 2024-02-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 30

Inclusion Criteria

• Female aged 18-40
• Have a regular menstrual cycle (every 21-35 days).
• Suffer from mild to moderate menstrual pain.
• May experience mood swings and/or hormonal acne related to the menstrual cycle.
• Otherwise generally healthy.
• Willing to consume the test product with a ginger flavor.
• Willing to refrain from taking any other supplements or prescription medications that may target the menstrual cycle or premenstrual syndrome (PMS) symptoms throughout the study period.
• Willing and able to adhere to the study protocol, including taking supplements at the required times and completing questionnaires via the technology portal.
• Able to communicate in English.
• Participants must provide written informed consent (ICF).

Exclusion Criteria

• Any unstable or uncontrolled medical or psychiatric illness.
• Any uncontrolled chronic disease or condition that would prevent full participation in the study protocol.
• A history of polycystic ovary syndrome (PCOS), endometriosis, premenstrual dysphoric disorder (PMDD), or undiagnosed vaginal bleeding.
• Are taking hormonal contraception or exogenous sex hormones (estrogen, testosterone, progesterone), or have taken hormonal contraception or exogenous hormones in the past 6 months.
• Are taking any prescription medication or supplements that target the menstrual cycle or PMS symptoms.
• Are pregnant, breastfeeding, trying to become pregnant, or have been pregnant in the past 12 months.
• Have any known severe allergic reactions, or any allergies of any severity to any of the test product's ingredients.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Cycle Bites	Funk It Cycle Bites	Participants will consume 1 Cycle Bite per day.

Primary Outcome Measures

Name	Time	Method
Changes in pain levels, including menstrual cramps. [Time Frame: Baseline to Month 4]	4 months	Survey-based assessment of acne using the Numerical Pain Rating Scale, a 0-10 point rating scale.
Changes in mood stability. [Time Frame: Baseline to Month 4]	4 months	Survey-based assessment using study-specific questionnaires. Responses will be gathered using a 5-point Likert scale.
Change in symptoms of premenstrual syndrome. [Time Frame: Baseline to Month 4]	4 months	Survey-based assessment of symptoms using the Premenstrual Symptoms Screening Tool (PSST). Responses will be gathered using a 4-point Likert scale.
Changes in energy levels. [Time Frame: Baseline to Month 4]	4 months	Survey-based assessment using study-specific questionnaires. Responses will be gathered using a 5-point Likert scale.
Changes in acne. [Time Frame: Baseline to Month 4]	4 months	Survey-based assessment of acne using the Acne Quality of Life (Acne-QOL) scale. Responses will be gathered using a 5-point Likert scale.

Secondary Outcome Measures

Name	Time	Method
Participant enjoyment of the product.	4 months	Survey-based assessment using study-specific questionnaires. Responses will be gathered using a 5-point Likert scale.

Trial Locations

Locations (1)

Citruslabs; 🇺🇸 Santa Monica, California, United States