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.

Study Overview

• Status: Completed
• Conditions: Polycystic Ovary Syndrome; Hormone Imbalance
• Intervention / Treatment: Dietary supplement: Optify Myo Inositol and D-Chiro Inositol Plus Folate and Vitamin D supplement

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Santa Monica, California, United States, 90404
      • Citruslabs

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Myo Inositol and D-Chiro Inositol Supplement; 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; This product contains Myo-Inositol, D-Chiro-Inositol, Folate and Vitamin D.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Optify
• Collaborators: Citruslabs

Study record dates

Study Major Dates

• Study Start (Actual): September 8, 2023
• Primary Completion (Actual): January 6, 2024
• Study Completion (Actual): January 6, 2024

Study Registration Dates

• First Submitted: November 28, 2023
• First Submitted That Met QC Criteria: November 28, 2023
• First Posted (Actual): December 6, 2023

Study Record Updates

• Last Update Posted (Actual): April 3, 2024
• Last Update Submitted That Met QC Criteria: April 1, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms; Endocrine System Diseases; Disease; Ovarian Cysts; Cysts; Ovarian Diseases; Adnexal Diseases; Gonadal Disorders; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Genital Diseases, Female; Polycystic Ovary Syndrome; Syndrome; Physiological Effects of Drugs; Micronutrients; Vitamins; Bone Density Conservation Agents; Vitamin B Complex; Vitamin D; Inositol
• Other Study ID Numbers: 20366

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No