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

NCT ID: NCT06158932

Last Updated: 2024-04-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-09-08

Study Completion Date

2024-01-06

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Polycystic Ovary Syndrome Hormone Imbalance

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type EXPERIMENTAL

Optify Myo Inositol and D-Chiro Inositol Plus Folate and Vitamin D supplement

Intervention Type DIETARY_SUPPLEMENT

This product contains Myo-Inositol, D-Chiro-Inositol, Folate and Vitamin D.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Citruslabs

INDUSTRY

Sponsor Role collaborator

Optify

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Citruslabs

Santa Monica, California, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

20366

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Microbiome and Polycystic Ovaries
NCT04836910 NOT_YET_RECRUITING
Oral Administration of DCI to Women With PCOS
NCT00497653 TERMINATED PHASE2/PHASE3