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

Premenstrual Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05900024
• Other study ID #: FunkItWellness
• Status: Completed
• Phase: N/A
• Start date: May 1, 2023
• Est. completion date: October 1, 2023

Study information

• Verified date: February 2024
• Source: Funk It Wellness
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: October 1, 2023
• Est. primary completion date: September 1, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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.

Related Conditions & MeSH terms

• Premenstrual Syndrome

Intervention

Other:
• Funk It Cycle Bites
The intervention product contains: Organic Pumpkin Seed Butter, Prebiotic Agave Inulin, Organic Flax Seed, Organic Oat Flour, Organic Ginger, Quinoa Sprouts, Crispy Red Rice, Organic Cacao Nibs, Sunflower Seed Butter, Organic Reishi Mushroom, Organic Amaranth Seeds, Dates, Organic Button Mushroom, Acai Berry, Amla Fruit, Goji Berry, Pomegranate, Cranberry, Acerola (Cherry Juice), Rosemary Extract, Vitamin E (Mixed Tocopherols), Organic Vanilla Extract, Sea Salt, Cinnamon, Naturally Sourced Potassium Sorbate.

Locations

Country	Name	City	State
United States	Citruslabs	Santa Monica	California

Sponsors (2)

Lead Sponsor	Collaborator
Funk It Wellness	Citruslabs

Country where clinical trial is conducted

United States, 

Outcome

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