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| Name | Class |
|---|---|
| Citruslabs | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cycle Bites | Experimental | Participants will consume 1 Cycle Bite per day. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Funk It Cycle Bites | 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. |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Citruslabs | Santa Monica | California | 90404 | United States |
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| ID | Term |
|---|---|
| D011293 | Premenstrual Syndrome |
| ID | Term |
|---|---|
| D008599 | Menstruation Disturbances |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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