Women's Hormonal and Metabolic Wellbeing Study

Daily Nouri

Status: Enrolling

Conditions: Metabolic Health

Treatments: Dietary Supplement: Placebo; Dietary Supplement: Probiotic Blend Capsule

Study type: Interventional

Funder types: Industry

Identifiers

NCT07268404

DNO001_14865

Details and patient eligibility

About

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

Full 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.

Enrollment: 60 estimated patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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60 participants in 2 patient groups, including a placebo group

Intervention: Dietary Supplement Capsule

Experimental group

Description:

Hormone Balance Probiotic blend

Treatment:

Dietary Supplement: Probiotic Blend Capsule

Placebo: Capsule

Placebo Comparator group

Description:

Identical capsule containing inactive ingredients

Treatment:

Dietary Supplement: Placebo