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

Polycystic Ovary Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06158932
• Other study ID #: 20366
• Status: Completed
• Phase: N/A
• Start date: September 8, 2023
• Est. completion date: January 6, 2024

Study information

• Verified date: April 2024
• Source: Optify
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: January 6, 2024
• Est. primary completion date: January 6, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Polycystic Ovary Syndrome
• Syndrome

Intervention

Dietary Supplement:
• Optify Myo Inositol and D-Chiro Inositol Plus Folate and Vitamin D supplement
This product contains Myo-Inositol, D-Chiro-Inositol, Folate and Vitamin D.

Locations

Country	Name	City	State
United States	Citruslabs	Santa Monica	California

Sponsors (2)

Lead Sponsor	Collaborator
Optify	Citruslabs

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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