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Completed

NCT Number: NCT06158932

A Single Group Study to Evaluate the Effects of a Myo-Inositol and D-Chiro Inositol Supplement on Symptoms Associated With Polycystic Ovary Syndrome and Hormone Imbalance

This is a virtual single group study that will last 12 weeks. 40 female participants will take 4 capsules of the Optify Myo Inositol and D-Chiro Inositol Plus Folate and Vitamin D supplement per day. Questionnaires will be completed at Baseline, Week 4, Week 8 and Week 12. Participants will also provide a waist circumference measurement at Baseline and Week 12.

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Key information

Conditions

Polycystic Ovary Syndrome Adnexal Diseases Cysts Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Gonadal Disorders Hormone Imbalance Neoplasms Ovarian Cysts Ovarian Diseases Urogenital Diseases

Age range

18 year–55 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Citruslabs

Santa Monica, California, 90404, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Women aged between 18 - 55
  • BMI less than 35
  • Self-reported symptoms of PCOS like irregular periods, excessive hair growth, weight gain, oily skin, or acne
  • Self-reported concerns around irregular menstrual cycles and ovulation, mood swings, stress, irritability, and low energy
  • Self-reported concerns with hormonal skin issues
  • Has access to a tape measure for waist measurement
  • Generally healthy - don't live with any uncontrolled chronic disease

Exclusion criteria

  • Anyone with pre-existing chronic conditions that would prevent participants from adhering to the protocol, including oncological and psychiatric disorders
  • Anyone with known severe allergic reactions
  • Anyone who is pregnant or breastfeeding
  • Unwilling to follow the study protocol

Treatment and study plan

Optify Myo Inositol and D-Chiro Inositol Plus Folate and Vitamin D supplement

Dietary Supplement

This product contains Myo-Inositol, D-Chiro-Inositol, Folate and Vitamin D.

Primary outcomes

  1. Changes in menstrual cycle regularity. [Timeframe: Baseline to Week 12]

    Time frame: 12 weeks

    Measured via study-specific questionnaires with participants reporting menstrual cycle occurrence and regularity during the trial.

  2. Changes in severity of menstrual cramps. [Timeframe: Baseline to Week 12]

    Time frame: 12 weeks

    Measured via study-specific questionnaires using a 5-point Likert scale. A lower score indicates a more favourable response, with 0=Not noticeable and 4=Severe.

  3. Changes in hormonal skin issues. [Timeframe: Baseline to Week 12]

    Time frame: 12 weeks

    Measured via study-specific questionnaires using a 5-point Likert scale. A lower score indicates a more favourable response, with 0=Not noticeable and 4=Severe.

  4. Changes in excessive body hair or facial hair. [Timeframe: Baseline to Week 12]

    Time frame: 12 weeks

    Measured via study-specific questionnaires using a 5-point Likert scale. A lower score indicates a more favourable response, with 0=Not noticeable and 4=Severe.

Secondary outcomes

  1. Changes in mood. [Timeframe: Baseline to Week 12]

    Time frame: 12 weeks

    Measured via study-specific questionnaires using a 5-point Likert scale. A lower score indicates a more favourable response, with 0=Not noticeable and 4=Severe.

  2. Changes in stress. [Timeframe: Baseline to Week 12]

    Time frame: 12 weeks

    Measured via study-specific questionnaires using a 5-point Likert scale. A lower score indicates a more favourable response, with 0=Not noticeable and 4=Severe.

  3. Changes in food cravings. [Timeframe: Baseline to Week 12]

    Time frame: 12 weeks

    Measured via study-specific questionnaires using a 5-point Likert scale. A lower score indicates a more favourable response, with 0=Not noticeable and 4=Severe.

  4. Changes in sleep quality. [Timeframe: Baseline to Week 12]

    Time frame: 12 weeks

    Measured via study-specific questionnaires using a 5-point Likert scale. A lower score indicates a more favourable response, with 0=Not noticeable and 4=Severe.

  5. Changes in energy. [Timeframe: Baseline to Week 12]

    Time frame: 12 weeks

    Measured via study-specific questionnaires using a 5-point Likert scale. A lower score indicates a more favourable response, with 0=Not noticeable and 4=Severe.

Sponsors and collaborators

Lead sponsor

Optify

Other

Collaborators

  • Citruslabs

Registry information

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Dec 6, 2023
Registry last updated
Apr 3, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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