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.

Study Overview

• Status: Completed
• Conditions: Premenstrual Syndrome
• Intervention / Treatment: Other: Funk It Cycle Bites

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Santa Monica, California, United States, 90404
      • Citruslabs

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Cycle Bites; Participants will consume 1 Cycle Bite per day.

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: Funk It Wellness
• Collaborators: Citruslabs

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2023
• Primary Completion (Actual): September 1, 2023
• Study Completion (Actual): October 1, 2023

Study Registration Dates

• First Submitted: June 2, 2023
• First Submitted That Met QC Criteria: June 2, 2023
• First Posted (Actual): June 12, 2023

Study Record Updates

• Last Update Posted (Estimated): February 29, 2024
• Last Update Submitted That Met QC Criteria: February 27, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Menstruation Disturbances; Premenstrual Syndrome
• Other Study ID Numbers: FunkItWellness

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No