Women's Hormonal and Metabolic Wellbeing Study

NCT07268404 | Recruiting

• 1 other identifier: DNO001_14865
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Metabolic Health

Keywords

dietary supplement; quality of life; women's health; hormone balance

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (8)

• Overall Health Quality of Life Scores

  12 weeks

• Change from baseline to Week 12 in Fasting Blood Glucose

  12 weeks

• Change from baseline to Week 12 in Glycated Hemoglobin A1c (HbA1c)

  12 weeks

• Change from baseline to Week 12 in High-Sensitivity C-Reactive Protein (hsCRP).

  12 weeks

• Supplementary Question - Sleep

  12 weeks

Study Arms (2)

Intervention: Dietary Supplement Capsule

EXPERIMENTAL

Hormone Balance Probiotic blend

Dietary Supplement: Probiotic Blend Capsule

Placebo: Capsule

PLACEBO COMPARATOR

Identical capsule containing inactive ingredients

Dietary Supplement: Placebo

Interventions

Placebo DIETARY_SUPPLEMENT

Placebo

Placebo: Capsule

Probiotic Blend Capsule DIETARY_SUPPLEMENT

Hormone Balance Probiotic Blend

Intervention: Dietary Supplement Capsule

Eligibility Criteria

• Age: 18 Years - 45 Years
• Gender Eligibility Details: women
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

Sponsors & Collaborators

• Daily Nouri: lead

Study Sites (1)

Alethios, Inc.

San Francisco, California, 94109, United States

RECRUITING

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 17, 2025
• First Posted: December 5, 2025
• Study Start: December 1, 2025
• Primary Completion: May 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: December 19, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)