This Study Aims to Evaluate Whether Milamend's Product Could Improve Hormone Balance in Women Who Suffer From Self-reported PCOS Symptoms.

Natural supplements are increasingly recognized as a viable and effective approach for impacting the multifaceted symptoms from hormone dysregulation that underlie conditions such as Polycystic Ovary Syndrome (PCOS). The investigational product for this study. Milamend Hormone Balance was developed to address multiple interlinked mechanisms common in PCOS and related endocrine concerns: insulin resistance, androgen excess, oxidative stress, thyroid dysfunction, gut dysbiosis, and mood regulation. Ingredient selection prioritized human evidence (RCTs/meta-analyses where available), bioavailable forms, and a systems approach spanning reproductive, metabolic, immune, and gut-brain axes.

The product's core ingredients are designed to support hormonal balance and insulin signaling, critical for conditions like PCOS. A blend of Myo- and D-chiro-inositol in a 40:1 ratio is included as it directly mimics the body's natural physiological ratio and is the most extensively studied blend for improving insulin sensitivity and restoring menstrual regularity. This blend helps to improve ovulation and reduce symptoms of high androgens, like hirsutism and acne. Chromium picolinate further supports this by enhancing insulin receptor signaling and managing blood sugar levels and cravings. Similarly, Zinc picolinate is included due to its role in insulin metabolism, hormone balance, and antioxidant defenses, which can improve menstrual and androgen-related symptoms. The final two ingredients in this category, Coenzyme Q10 (CoQ10) and Alpha-lipoic acid (ALA), work together to support mitochondrial function and reduce oxidative stress. This is particularly beneficial for egg/embryology quality and overall cellular energy, with both ingredients showing positive results in studies related to insulin resistance and fertility outcomes.

Several ingredients in the supplement provide foundational support for overall health and well-being. Folate (as 5-MTHF) is the active form of vitamin B9 and is crucial for DNA synthesis, egg maturation, and methylation pathways. It is especially beneficial for individuals with specific genetic variations (MTHFR polymorphism) that affect folate processing. Vitamin B6 (as P5P), its active form, is included to support neurotransmitter synthesis, particularly for serotonin and melatonin, which can help alleviate PMS symptoms and improve mood and sleep. Selenium, in the form of L-selenomethionine, is an essential antioxidant that supports thyroid function and the conversion of thyroid hormones. When combined with inositol, it has been shown to improve thyroid antibodies and menstrual regularity. This is especially helpful for women with both thyroid dysfunction and hormonal imbalances.

The supplement also addresses common co-morbidities associated with hormonal imbalances by including a blend of amino acids. L-glutamine supports gut barrier integrity, which is often compromised in conditions like PCOS, and helps reduce inflammation. L-lysine is included for immune support and its role in collagen and elastin production, which is important for skin health. L-carnitine tartrate supports mitochondrial energy and fatty acid metabolism, helping to combat the fatigue often associated with insulin resistance. Finally, L-tryptophan is a precursor to serotonin and melatonin, helping to manage mood and sleep disturbances. L-threonine is also included to support immune function, collagen synthesis, and tissue repair, contributing to overall health and resilience.

Inclusion criteria

• 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.

Exclusion criteria

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
• 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:
• Perimenopausal or menopausal.
• 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 pregnant, planning to become pregnant in the next 3 months, or breastfeeding
• 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.
• 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.