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| Name | Class |
|---|---|
| Citruslabs | INDUSTRY |
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This is a virtual single group study that will last 12 weeks. 40 female participants will take 4 capsules of the Optify Myo Inositol and D-Chiro Inositol Plus Folate and Vitamin D supplement per day. Questionnaires will be completed at Baseline, Week 4, Week 8 and Week 12. Participants will also provide a waist circumference measurement at Baseline and Week 12.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Myo Inositol and D-Chiro Inositol Supplement | Experimental | Participants must take 4 capsules per day, with water. The product should be taken with the last meal of the day. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Optify Myo Inositol and D-Chiro Inositol Plus Folate and Vitamin D supplement | Dietary Supplement | This product contains Myo-Inositol, D-Chiro-Inositol, Folate and Vitamin D. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Changes in menstrual cycle regularity. [Timeframe: Baseline to Week 12] | Measured via study-specific questionnaires with participants reporting menstrual cycle occurrence and regularity during the trial. | 12 weeks |
| Changes in severity of menstrual cramps. [Timeframe: Baseline to Week 12] | Measured via study-specific questionnaires using a 5-point Likert scale. A lower score indicates a more favourable response, with 0=Not noticeable and 4=Severe. | 12 weeks |
| Changes in hormonal skin issues. [Timeframe: Baseline to Week 12] | Measured via study-specific questionnaires using a 5-point Likert scale. A lower score indicates a more favourable response, with 0=Not noticeable and 4=Severe. | 12 weeks |
| Changes in excessive body hair or facial hair. [Timeframe: Baseline to Week 12] | Measured via study-specific questionnaires using a 5-point Likert scale. A lower score indicates a more favourable response, with 0=Not noticeable and 4=Severe. | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in mood. [Timeframe: Baseline to Week 12] | Measured via study-specific questionnaires using a 5-point Likert scale. A lower score indicates a more favourable response, with 0=Not noticeable and 4=Severe. | 12 weeks |
| Changes in stress. [Timeframe: Baseline to Week 12] |
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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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Measured via study-specific questionnaires using a 5-point Likert scale. A lower score indicates a more favourable response, with 0=Not noticeable and 4=Severe. |
| 12 weeks |
| Changes in food cravings. [Timeframe: Baseline to Week 12] | Measured via study-specific questionnaires using a 5-point Likert scale. A lower score indicates a more favourable response, with 0=Not noticeable and 4=Severe. | 12 weeks |
| Changes in sleep quality. [Timeframe: Baseline to Week 12] | Measured via study-specific questionnaires using a 5-point Likert scale. A lower score indicates a more favourable response, with 0=Not noticeable and 4=Severe. | 12 weeks |
| Changes in energy. [Timeframe: Baseline to Week 12] | Measured via study-specific questionnaires using a 5-point Likert scale. A lower score indicates a more favourable response, with 0=Not noticeable and 4=Severe. | 12 weeks |
| ID | Term |
|---|---|
| D011085 | Polycystic Ovary Syndrome |
| ID | Term |
|---|---|
| D010048 | Ovarian Cysts |
| D003560 | Cysts |
| D009369 | Neoplasms |
| D010049 | Ovarian Diseases |
| D000291 | Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D006058 | Gonadal Disorders |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| D005492 | Folic Acid |
| ID | Term |
|---|---|
| D011622 | Pterins |
| D011621 | Pteridines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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