Testing a Dietary Supplement for Hormone Balance in Women With PCOS Symptoms

Who can take part

• Females between 18-40 years old, inclusive
• Known diagnosis of Polycystic Ovarian Syndrome (PCOS) OR likely have PCOS as defined by presence of:
• Oligomenorrhea (<9 menstrual cycles in the past year)
• Signs of hyperandrogenism (hirsutism, acne, female-pattern hair loss)
• Has recorded menstrual cycle duration of at least 3 menstrual cycles in the past year
• BMI of 18.5-35
• Owns or is willing to purchase a personal digital weight scale for monthly weight measurement
• In good general health at the time of screening (Investigator discretion)
• Able to read and understand English
• Able to read, understand, and provide informed consent
• Able to use a personal smartphone device and download Chloe by People Science
• Able to receive shipment of the product at an address within the United States
• Able to complete study assessments over the course of up to 16 weeks

Who cannot take part

• Concomitant Therapies:; Use of hormonal contraceptives within the last 6 months; Use of a Co-Q10 supplement within the last 6 months; Use of any high dose vitamin B supplements in the last 6 months; Received any investigational therapies or treatments within 30 days prior to randomization; Use of any other alpha-inositol/myo-inositol supplement in the last 6 months; Pioglitazone, spironolactone or metformin in the previous 6 months
• Other Illnesses or Conditions: Participants who have the following comorbidities or gastrointestinal illnesses are excluded:
• Participants diagnosed with Diabetes Mellitus (DM) for both Type I and Type II, who are managed with Insulin, Thiazolidinediones (TZDs) or Metformin
• Known diagnosis of other causes of oligomenorrhea (e.g. thyroid disease, primary ovarian insufficiency, hyperprolactinemia, Cushing syndrome, any disorders of sexual development or Obesity)
• Chronic hepatic, renal, or cardiovascular disease (excluding hypertension)
• Known disorders that would affect nutrient absorption (e.g., Crohn's Disease, ulcerative colitis, chronic diarrhea, Celiac Disease, Irritable Bowel Syndrome, eating disorder)
• Currently diagnosed with Alcohol Use Disorder and/or Substance Use Disorder
• Any underlying medical conditions or comorbidities that may confound the assessment of digestive symptoms or the evaluation of the study outcomes
• Have a significant illness, disease or condition which, in the opinion of the principal investigator, may impact their ability to participate in the study or impact the study outcomes
• Other possible causes of oligomenorrhea such as history of disordered eating, chronic jetlag or shiftwork
• Known hypersensitivity or previous allergic reaction to the product ingredients: Vitamin B6 (as Pyridoxal-5-Phosphate), Folate (as L-5-Methyltetrahydrofolate Calcium), Zinc (as Zinc Picolinate), Selenium (as L-Selenomethionine), Chromium (as Chromium Picolinate), Myo-inositol, D-chiro-inositol, Co-enzyme Q10, Alpha Lipoic Acid, L-Glutamine, L-Carnitine Tartrate, L-Lysine (as L-Lysine HCl), L-Threonine, L-Tryptophan, beet root powder, hibiscus, or spirulina (algae) or citric acid
• Any potential participants who:
• Do not have a personal smartphone, internet access, or unwilling to download Chloe
• Rates the impact of PCOS on their overall quality of life as "Rarely/Seldom" or "Not at all"
• Average cycle length of last 3 cycles is >50 days
• Perimenopausal or menopausal
• Currently pregnant, planning to become pregnant in the next 3 months, or breastfeeding
• Are unlikely for any reason to be able to comply with the trial or considered unsuited for participation in the study by the Principal Investigator