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

NCT ID: NCT05900024

Last Updated: 2024-02-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-05-01
• Study Completion Date: 2023-10-01

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.

Conditions

Premenstrual Syndrome

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Cycle Bites

Participants will consume 1 Cycle Bite per day.

Group Type: EXPERIMENTAL

Funk It Cycle Bites

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Citruslabs

INDUSTRY

Sponsor Role: collaborator

Funk It Wellness

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Citruslabs

Santa Monica, California, United States

Countries

United States

Other Identifiers

FunkItWellness

Identifier Type: -

Identifier Source: org_study_id