An interventional study of Funk It Cycle Bites in Premenstrual Syndrome, sponsored by Funk It Wellness. Completed at 1 site in United States. Open to female participants aged 18 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-02-29.
Sponsored by Funk It Wellness · Not applicable, Interventional, and Other
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.
177 studies on the registry are indexed under Premenstrual Syndrome; 30 are open to participants now.
This study's enrollment of 30 is below the median of 70 across 153 interventional studies indexed under Premenstrual Syndrome.
Browse Premenstrual Syndrome studies →This is the only study on the registry with Funk It Wellness as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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.
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 4 months
Participant enjoyment of the product.
Survey-based assessment using study-specific questionnaires. Responses will be gathered using a 5-point Likert scale.
Time frame: 4 months
Plan to share: Undecided
No publications or documents are linked to this record.
This study is completed, as verified in Feb 2024. You cannot join it, but the record below documents what was studied.
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