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

An Open-Label, Single-Group Study to Evaluate the Effect of Funk It Cycle Bites on PMS

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.

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.