Hormone Imbalance, Polycystic Ovary Syndrome
Conditions
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.
Interventions
DIETARY_SUPPLEMENTOptify Myo Inositol and D-Chiro Inositol Plus Folate and Vitamin D supplement
This product contains Myo-Inositol, D-Chiro-Inositol, Folate and Vitamin D.
Sponsors
Citruslabs
Optify
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 55 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes in menstrual cycle regularity. [Timeframe: Baseline to Week 12] | 12 weeks | Measured via study-specific questionnaires with participants reporting menstrual cycle occurrence and regularity during the trial. |
| Changes in severity of menstrual cramps. [Timeframe: Baseline to Week 12] | 12 weeks | 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. |
| Changes in hormonal skin issues. [Timeframe: Baseline to Week 12] | 12 weeks | 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. |
| Changes in excessive body hair or facial hair. [Timeframe: Baseline to Week 12] | 12 weeks | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes in mood. [Timeframe: Baseline to Week 12] | 12 weeks | 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. |
| Changes in energy. [Timeframe: Baseline to Week 12] | 12 weeks | 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. |
| Changes in stress. [Timeframe: Baseline to Week 12] | 12 weeks | 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. |
| Changes in food cravings. [Timeframe: Baseline to Week 12] | 12 weeks | 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. |
| Changes in sleep quality. [Timeframe: Baseline to Week 12] | 12 weeks | 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. |
Countries
United States
Outcome results
None listed