Women's Hormonal and Metabolic Wellbeing Study

Daily Nouri60 enrolled

Overview

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: * Take the probiotic blend or placebo every day for 12 weeks * Complete virtual assessments and report symptoms throughout the study

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

TRIPLE

Enrollment

Conditions

Metabolic Health

Interventions

Probiotic Blend CapsuleDIETARY_SUPPLEMENT

Hormone Balance Probiotic Blend

PlaceboDIETARY_SUPPLEMENT

Placebo

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 45 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Self-reported irregular menstrual cycles, defined as one or more of the following: * Cycle length typically \>35 days OR \<21 days * Fewer than 9 menstrual periods in the past year * Unpredictable cycle timing (varies by \>7 days month-to-month) * Irregular cycles present for ≥6 months * 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: * Mood swings or irritability * Feelings of stress or tension * Low mood or feeling down * Difficulty with emotional regulation * 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.

Locations (1)

Alethios, Inc.

San Francisco, California, United States

RECRUITING

Outcomes

Primary Outcomes

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.

Time frame: From baseline to week 12

Secondary Outcomes

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.

Time frame: 12 weeks

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).

Time frame: 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 (%).

Time frame: 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).

Time frame: 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)

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.