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

Summary

The rationale for this study is to observe the impact of a consumer-grade commercially available product called Milamend Hormone Balance on quality of life and hormonal health in women with self-reported symptoms associated with Polycystic Ovarian Syndrome (PCOS). Additionally, the study aims to observe the impact of the product on menstrual cycle structure and associated symptoms, on reproductive and metabolic markers, on body image concerns, anxiety and general well-being. A consumer-driven, decentralized observational clinical research study is therefore well-suited for examining the effects of this product in this population. We will examine the outcomes in a broad age-range of premenopausal women who have chosen to try this product. The study will incorporate participant reported outcome questionnaires and surveys and at-home blood specimen collection. There is no "doctor-patient" relationship as part of this research since the participant as a consumer is making the informed choice to try the product and take part in the observational process with self-reported measures, cycle tracking and at-home blood sample collection. Findings from this study will contribute knowledge toward the tolerability and formulation of the product and the design of future studies.

Detailed Description

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.

Eligibility Criteria

Interventions