Back to resultsA Study to Evaluate the Effect of Funk It Cycle Bites on PMS
Primary Purpose
Premenstrual Syndrome
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Funk It Cycle Bites
Sponsored by
About this trial
This is an interventional other trial for Premenstrual Syndrome
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.
Sites / Locations
- CitruslabsRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Cycle Bites
Arm Description
Participants will consume 1 Cycle Bite per day.
Outcomes
Primary Outcome Measures
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.
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.
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.
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.
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.
Secondary Outcome Measures
Participant enjoyment of the product.
Survey-based assessment using study-specific questionnaires. Responses will be gathered using a 5-point Likert scale.
Full Information
NCT ID
NCT05900024
First Posted
June 2, 2023
Last Updated
June 2, 2023
Sponsor
Funk It Wellness
Collaborators
Citruslabs
1. Study Identification
Unique Protocol Identification Number
NCT05900024
Brief Title
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
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 1, 2023 (Actual)
Primary Completion Date
September 1, 2023 (Anticipated)
Study Completion Date
October 1, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Funk It Wellness
Collaborators
Citruslabs
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Premenstrual Syndrome
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Cycle Bites
Arm Type
Experimental
Arm Description
Participants will consume 1 Cycle Bite per day.
Intervention Type
Other
Intervention Name(s)
Funk It Cycle Bites
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in symptoms of premenstrual syndrome. [Time Frame: Baseline to Month 4]
Description
Survey-based assessment of symptoms using the Premenstrual Symptoms Screening Tool (PSST). Responses will be gathered using a 4-point Likert scale.
Time Frame
4 months
Title
Changes in acne. [Time Frame: Baseline to Month 4]
Description
Survey-based assessment of acne using the Acne Quality of Life (Acne-QOL) scale. Responses will be gathered using a 5-point Likert scale.
Time Frame
4 months
Title
Changes in pain levels, including menstrual cramps. [Time Frame: Baseline to Month 4]
Description
Survey-based assessment of acne using the Numerical Pain Rating Scale, a 0-10 point rating scale.
Time Frame
4 months
Title
Changes in mood stability. [Time Frame: Baseline to Month 4]
Description
Survey-based assessment using study-specific questionnaires. Responses will be gathered using a 5-point Likert scale.
Time Frame
4 months
Title
Changes in energy levels. [Time Frame: Baseline to Month 4]
Description
Survey-based assessment using study-specific questionnaires. Responses will be gathered using a 5-point Likert scale.
Time Frame
4 months
Secondary Outcome Measure Information:
Title
Participant enjoyment of the product.
Description
Survey-based assessment using study-specific questionnaires. Responses will be gathered using a 5-point Likert scale.
Time Frame
4 months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Facility Information:
Facility Name
Citruslabs
City
Santa Monica
State/Province
California
ZIP/Postal Code
90404
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Patrick Renner, MSc
Phone
424-245-0285
Email
hello@citruslabs.com
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
A Study to Evaluate the Effect of Funk It Cycle Bites on PMS
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