Women's Hormonal and Metabolic Wellbeing Study

Официальное название

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

Обзор

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

Подробное описание

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.

Вмешательства

• Пищевая добавка Probiotic Blend Capsule
  Hormone Balance Probiotic Blend
• Пищевая добавка Placebo
  Placebo

Первичные конечные точки

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

Вторичные конечные точки (8)

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

Критерии участия

Критерии включения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Тройное слепое

Основная цель

Поддерживающая терапия

Центры проведения

США · 1 центр

• Alethios, Inc. — San Francisco

Идентификаторы

NCT: NCT07268404 · DNO001_14865

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗