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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Polycystic Ovary Syndrome, Hormone Imbalance

Intervention / Treatment
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* Dietary Supplement: Optify Myo Inositol and D-Chiro Inositol Plus Folate and Vitamin D supplement


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Myo Inositol and D-Chiro Inositol Supplement<br>Participants must take 4 capsules per day, with water. The product should be taken with the last meal of the day. | Dietary Supplement: Optify Myo Inositol and D-Chiro Inositol Plus Folate and Vitamin D supplement<br>* This product contains Myo-Inositol, D-Chiro-Inositol, Folate and Vitamin D.<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in mood. [Timeframe: Baseline to Week 12] | 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. | 12 weeks | 
| Changes in stress. [Timeframe: Baseline to Week 12] | 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. | 12 weeks | 
| Changes in food cravings. [Timeframe: Baseline to Week 12] | 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. | 12 weeks | 
| Changes in sleep quality. [Timeframe: Baseline to Week 12] | 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. | 12 weeks | 
| Changes in energy. [Timeframe: Baseline to Week 12] | 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. | 12 weeks |