Women's Hormonal and Metabolic Wellbeing Study

Official title

A 12-Week Virtual, Randomized, Double-Blind, Placebo-Controlled Trial Evaluating the Effects of Daily Nouri Hormone Balance Probiotic on Metabolic, Inflammatory, and Symptom Outcomes in Women

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

Detailed description

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.

Interventions

• Dietary supplement Probiotic Blend Capsule
  Hormone Balance Probiotic Blend
• Dietary supplement Placebo
  Placebo

Primary outcome measures

• Women's Health Quality of Life Scores [Time frame: From baseline to week 12]

Secondary outcome measures (8)

• Overall Health Quality of Life Scores [Time frame: 12 weeks]
• Change from baseline to Week 12 in Fasting Blood Glucose [Time frame: 12 weeks]
• Change from baseline to Week 12 in Glycated Hemoglobin A1c (HbA1c) [Time frame: 12 weeks]
• Change from baseline to Week 12 in High-Sensitivity C-Reactive Protein (hsCRP). [Time frame: 12 weeks]
• Supplementary Question - Sleep [Time frame: 12 weeks]
• Supplementary Question - Acne Severity [Time frame: 12 weeks]
• Supplementary Question - Acne [Time frame: 12 weeks]
• Supplementary Question - Sexual Health [Time frame: 12 weeks]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Triple blind

Primary purpose

Supportive care

Study locations

United States · 1 center

• Alethios, Inc. — San Francisco

Identifiers

NCT: NCT07268404 · DNO001_14865

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗