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

Not Applicable

Completed

• Conditions: Hormone Imbalance; Polycystic Ovary Syndrome
• Interventions: Dietary Supplement: Optify Myo Inositol and D-Chiro Inositol Plus Folate and Vitamin D supplement

• Registration Number: NCT06158932
• Lead Sponsor: Optify

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-09-08
• Study First Submitted: 2023-11-28
• Study First Submitted QC: 2023-11-28
• Study First Posted: 2023-12-06
• Primary Completion: 2024-01-06
• Study Completion: 2024-01-06
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-01
• Last Update Posted: 2024-04-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Myo Inositol and D-Chiro Inositol Supplement	Optify Myo Inositol and D-Chiro Inositol Plus Folate and Vitamin D supplement	Participants must take 4 capsules per day, with water. The product should be taken with the last meal of the day.

Primary Outcome Measures

Name	Time	Method
Changes in menstrual cycle regularity. [Timeframe: Baseline to Week 12]	12 weeks	Measured via study-specific questionnaires with participants reporting menstrual cycle occurrence and regularity during the trial.
Changes in hormonal skin issues. [Timeframe: Baseline to Week 12]	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.
Changes in excessive body hair or facial hair. [Timeframe: Baseline to Week 12]	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.
Changes in severity of menstrual cramps. [Timeframe: Baseline to Week 12]	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 Outcome Measures

Name	Time	Method
Changes in sleep quality. [Timeframe: Baseline to Week 12]	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.
Changes in energy. [Timeframe: Baseline to Week 12]	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.
Changes in mood. [Timeframe: Baseline to Week 12]	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.
Changes in stress. [Timeframe: Baseline to Week 12]	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.
Changes in food cravings. [Timeframe: Baseline to Week 12]	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.

Trial Locations

Locations (1)

Citruslabs; 🇺🇸 Santa Monica, California, United States