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
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Daily Nouri
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Women's Health Quality of Life Scores
Overview
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
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- Triple (Participant, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 45 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- Yes
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
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Women's Health Quality of Life Scores
Time Frame: From baseline to week 12
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.
Secondary Outcomes
- 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)
- Supplementary Question - Acne Severity(12 weeks)
- Supplementary Question - Acne(12 weeks)
- Supplementary Question - Sexual Health(12 weeks)