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

NCT06158932 | Completed

• 1 other identifier: 20366
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Polycystic Ovary Syndrome; Hormone Imbalance

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (5)

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

  12 weeks

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

  12 weeks

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

  12 weeks

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

  12 weeks

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

  12 weeks

Study Arms (1)

Myo Inositol and D-Chiro Inositol Supplement

EXPERIMENTAL

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

Interventions

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.

Myo Inositol and D-Chiro Inositol Supplement

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Optify: lead
• Citruslabs: collaborator

Study Sites (1)

Citruslabs

Santa Monica, California, 90404, United States

Location

MeSH Terms

Conditions

Polycystic Ovary Syndrome

Interventions

Folic Acid

Condition Hierarchy (Ancestors)

Ovarian Cysts; Cysts; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Gonadal Disorders; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 28, 2023
• First Posted: December 6, 2023
• Study Start: September 8, 2023
• Primary Completion: January 6, 2024
• Study Completion: January 6, 2024
• Last Updated: April 3, 2024

Record last verified: 2024-04

Locations

US (1)