Health TrialsbyHealthPanel

Women's Hormonal and Metabolic Wellbeing Study

ConditionMetabolic Health
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-45
SponsorDaily Nouri

About this trial

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

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

  • Probiotic Blend Capsule

    Dietary supplement

    Hormone Balance Probiotic Blend

  • Placebo

    Dietary supplement

    Placebo

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: Intervention: Dietary Supplement CapsuleExperimental treatment 1 intervention
Group B: Placebo: CapsulePlacebo comparator 1 intervention

Trial outcomes

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.

Time frame
From baseline to week 12

Secondary outcomes

1

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
2

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
3

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
4

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Daily Nouri

Lead sponsor

Source ClinicalTrials.gov
Apply now