Clinical trial NCT05900024: A Study to Evaluate the Effect of Funk It Cycle Bites on PMS
Official title: An Open-Label, Single-Group Study to Evaluate the Effect of Funk It Cycle Bites on PMS
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Premenstrual Syndrome
Lead sponsor: Funk It Wellness
Sponsor class: INDUSTRY
Collaborators: name: Citruslabs
First posted: 2023-06-12
Enrollment: 30
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Change in symptoms of premenstrual syndrome. [Time Frame: Baseline to Month 4]
timeFrame: 4 months
measure: Changes in acne. [Time Frame: Baseline to Month 4]
timeFrame: 4 months
measure: Changes in pain levels, including menstrual cramps. [Time Frame: Baseline to Month 4]
timeFrame: 4 months
measure: Changes in mood stability. [Time Frame: Baseline to Month 4]
timeFrame: 4 months
measure: Changes in energy levels. [Time Frame: Baseline to Month 4]
timeFrame: 4 months
Secondary outcomes:
measure: Participant enjoyment of the product.
timeFrame: 4 months
Other outcomes:
Locations:
city: Santa Monica
country: United States
facility: Citruslabs
state: California
Study officials:
References: