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The goal of this clinical trial is to learn if Daily Nouri Hormone Balance Probiotic blend can improve metabolic, inflammatory, and symptom outcomes in women.
Participants will:
This study is a 12-week, prospective, randomized, controlled clinical trial. It is an interventional study with participants assigned to either an active or control group. All study visits will be conducted virtually, including completion of questionnaires, collection of blood samples, and other assessments.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention: Dietary Supplement Capsule | Experimental | Hormone Balance Probiotic blend |
|
| Placebo: Capsule | Placebo Comparator | Identical capsule containing inactive ingredients |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Probiotic Blend Capsule | Dietary Supplement | Hormone Balance Probiotic Blend |
|
| Measure | Description | Time Frame |
|---|---|---|
| Women's Health Quality of Life Scores | Women's Health Quality of Life as measured by changes in total and domains scores on the Health-Related Quality of Life Questionnaire for Polycystic Ovary Syndrome-26 (PCOSQ-26). Response Scale: 7-Point Likert Scale Per-Item Range: minimum: 1, maximum: 7, where higher scores indicate better outcomes. | From baseline to week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Health Quality of Life Scores | Assessed by monthly Patient-Reported Outcomes Measurement Information System - 29 Profile (PROMIS-29) questionnaire. 28 items use 5-point Likert scale responses (0-4), 1 item is a numeric rating scale (0-10). For negatively-worded concepts higher scores indicate worse outcomes, for positively-worded concepts higher scores indicate better outcomes. | 12 weeks |
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Inclusion Criteria:
Self-reported irregular menstrual cycles, defined as one or more of the following:
One or more of the following hormonal balance concerns: skin, unwanted hair growth, hair thinning, weight concerns)
Self-reported emotional symptoms that fluctuate with menstrual cycle, including:
Not currently using hormonal therapies, metformin, GLP-1 receptor agonists, or anti-androgens.
If taking supplements for menstrual/hormonal support: willing to discontinue for 2-week washout before baseline
Weight stable (+ 5 pounds) for the past 2 months, not planning to start a new diet, exercise program, or medications during study
Able to provide electronic informed consent.
Willing to complete online surveys and at-home DBS sample collection.
Negative home pregnancy test at baseline.
Access to a computer or smartphone and reliable internet connection.
women
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Alethios, Inc. | Recruiting | San Francisco | California | 94109 | United States |
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| Placebo | Dietary Supplement | Placebo |
|
| Change from baseline to Week 12 in Fasting Blood Glucose | Fasting Blood Glucose will be analyzed from dried blood spots (DBS), reported as mg/dL (milligrams per deciliter). | 12 weeks |
| Change from baseline to Week 12 in Glycated Hemoglobin A1c (HbA1c) | HbA1c will be analyzed from dried blood spots (DBS), reported as percentage (%). | 12 weeks |
| Change from baseline to Week 12 in High-Sensitivity C-Reactive Protein (hsCRP). | hsCRP will be analyzed from dried blood spots (DBS), reported as mg/L (milligrams per liter). | 12 weeks |
| Supplementary Question - Sleep | Over the past 7 days, how would you rate your sleep quality overall? Visual Analog Scale, (0 = very poor, 10 = excellent) Over the past 7 days, how would you rate your energy level? Visual Analog Scale (0 = no energy/extremely fatigued, 10 = full energy/not fatigued at all) | 12 weeks |
| Supplementary Question - Acne Severity | How would you rate the severity of your acne over the past 7 days? Visual Analog Scale, (Response: 0-10 scale, where 0 = no acne and 10 = severe acne) | 12 weeks |
| Supplementary Question - Acne | To what extent does your acne currently affect your quality of life? (Response: 5-point Likert, from 'not at all' to 'extremely') | 12 weeks |
| Supplementary Question - Sexual Health | Over the past 7 days, how would you rate your overall sexual interest and satisfaction? Visual Analog Scale (0 = Very poor, 10 = Excellent) | 12 weeks |