Polycystic Ovarian Syndrome (PCOS)NCT07764328
This Study Aims to Evaluate Whether Milamend's Product Could Improve Hormone Balance in Women Who Suffer From Self-reported PCOS Symptoms.
A study testing A dietary supplement powder for women in people with Polycystic Ovarian Syndrome (PCOS), run by Mila Mend Inc. at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Polycystic Ovarian Syndrome (PCOS)
- What is being tested?
- A dietary supplement powder for women
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 225 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Dec 2025to 30 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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
Show all 13Show fewer
- 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 join
- 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.
Show all 24Show fewer
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
People Science, Inc.
Los Angeles, California, 90034
Noah Craft, M.D., Ph.D., 213-328-0919, noah@peoplescience.health
About this study
Official title: A Randomized, Double-blind, Placebo-controlled Study Evaluating the Impact of Milamend on Quality of Life and Hormonal Health in Women With Self-Reported Symptoms Associated With Polycystic Ovary Syndrome (PCOS)
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.
Read the 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.
- Conditions
- Polycystic Ovarian Syndrome (PCOS)
- Being tested
- A dietary supplement powder for women, Placebo
- Keywords
- Polycystic Ovarian Syndrome, PCOS, Quality of Life, Hormonal Health, Oligomenorrhea, hyperandrogenism
- Medical subject headings
- Polycystic Ovary Syndrome, Oligomenorrhea, Hyperandrogenism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
A dietary supplement powder for womenDietary supplement
Also called Hormone Balance supplement
1 scoop/day mixed with ≥8 oz water for the first 3 days at study start and then increase to 1 scoop twice daily (AM/PM) with food.
PlaceboDietary supplement
Also called Hormone Balance Supplement Placebo
1 scoop/day mixed with ≥8 oz water for the first 3 days at study start and then increase to 1 scoop twice daily (AM/PM) with food.
| Study group | Role | What they receive |
|---|---|---|
| Placebo Arm | Placebo comparator | Control Arm using the placebo Receives: Dietary Supplement: Placebo |
| Study Product Arm | Experimental | Experimental study arm will use the Milamend Hormone Balance supplement Receives: Dietary Supplement: A dietary supplement powder for women |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of Life Impact
To evaluate the impact of Milamend product on quality of life associated with PCOS symptoms.
Change in health-related quality of life score between placebo and study product group as measured by the PCOS-QOL. Baseline will be compared as well.
Measured: 13 weeks
Secondary outcomes (7)
Menstrual Cycle Frequency, Function and Length Impact
To evaluate the impact of Milamend on menstrual cycle frequency. Change in presence of LH surges between study product and placebo groups.
Measured: 12 weeks
Menstrual Cycle Symptoms Impact
To evaluate the impact of Milamend on menstrual cycle symptoms. Change in the incidence, characteristics and/or severity of cycle symptoms between study product and placebo groups.
Measured: 12 weeks
General Well-Being Impact
To evaluate the impact of Milamend product on general well-being. Change in general well-being score between placebo and study product group as measured by the Patient Health Questionnaire-9 (PHQ-9). Baseline will be compared as well.
Measured: 13 weeks
Impact on Anxiety
To evaluate the impact of Milamend on anxiety. Change in anxiety score between placebo and study product group as measured by GAD-7. Baseline will be compared as well.
Measured: 13 weeks
Body Image Impact
To evaluate the impact of Milamend product on body image concern. Change in body image concern score between placebo and study product group as measured by the Body Image Concern Inventory (BICDI). Baseline will be compared as well.
Measured: 13 weeks
Hormone and Metabolic Blood Marker Impact
To assess the impact of Milamend product on hormone and metabolic blood markers.
Change from baseline in hormone and metabolic blood markers at Week 12 as measured by blood collection.
Measured: Baseline to Week 12
Safety and Tolerability Assessment
To observe the safety and tolerability of Milamend's product. Assessment of the number, frequency, and severity of adverse events (AEs), serious adverse events (SAEs) and AE withdrawals reported over the study product and placebo use period.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2026
- Study start23 Dec 2025
- Primary completion27 Oct 2026 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (18)Papers the sponsor has linked to this study.
- Other trials for Polycystic Ovarian Syndrome (PCOS)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 225 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mila Mend Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- People Science, Inc.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07764328
- Sponsor's protocol ID
- PS27
- Status last verified
- Aug 2026
- First submitted
- 29 Jul 2026
- Last updated
- 13 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
PDF. Accessed September 3, 2025. https://www.europeanreview.org/wp/wp-content/uploads/5512-5521.pdf
Mao X, Zeng X, Qiao S, Wu G, Li D. Specific roles of threonine in intestinal mucosal integrity and barrier function. Front Biosci (Elite Ed). 2011 Jun 1;3(4):1192-200. doi: 10.2741/e322.
PubMed 21622125Finlay D, Cantrell D. The coordination of T-cell function by serine/threonine kinases. Cold Spring Harb Perspect Biol. 2011 Jan 1;3(1):a002261. doi: 10.1101/cshperspect.a002261.
PubMed 21421912Roth W, Zadeh K, Vekariya R, Ge Y, Mohamadzadeh M. Tryptophan Metabolism and Gut-Brain Homeostasis. Int J Mol Sci. 2021 Mar 15;22(6):2973. doi: 10.3390/ijms22062973.
PubMed 33804088Anderson G. Polycystic Ovary Syndrome Pathophysiology: Integrating Systemic, CNS and Circadian Processes. Front Biosci (Landmark Ed). 2024 Jan 18;29(1):24. doi: 10.31083/j.fbl2901024.
PubMed 38287831Gong Y, Jiang T, He H, Wang Y, Wu GL, Shi Y, Cai Q, Xiong CL, Shen R, Li J. Effects of carnitine on glucose and lipid metabolic profiles and fertility outcomes in women with polycystic ovary syndrome: A systematic review and meta-analysis. Clin Endocrinol (Oxf). 2023 May;98(5):682-691. doi: 10.1111/cen.14885. Epub 2023 Feb 17.
PubMed 36746677Papachroni KK, Piperi C, Levidou G, Korkolopoulou P, Pawelczyk L, Diamanti-Kandarakis E, Papavassiliou AG. Lysyl oxidase interacts with AGE signalling to modulate collagen synthesis in polycystic ovarian tissue. J Cell Mol Med. 2010 Oct;14(10):2460-9. doi: 10.1111/j.1582-4934.2009.00841.x.
PubMed 19583806Unni SN, Lakshman LR, Vaidyanathan K, Subhakumari KN, Menon NL. Alterations in the levels of plasma amino acids in polycystic ovary syndrome--A pilot study. Indian J Med Res. 2015 Nov;142(5):549-54. doi: 10.4103/0971-5916.171281.
PubMed 26658589Kim MH, Kim H. The Roles of Glutamine in the Intestine and Its Implication in Intestinal Diseases. Int J Mol Sci. 2017 May 12;18(5):1051. doi: 10.3390/ijms18051051.
PubMed 28498331Wang P, Chen B, Huang Y, Li J, Cao D, Chen Z, Li J, Ran B, Yang J, Wang R, Wei Q, Dong Q, Liu L. Selenium intake and multiple health-related outcomes: an umbrella review of meta-analyses. Front Nutr. 2023 Sep 13;10:1263853. doi: 10.3389/fnut.2023.1263853. eCollection 2023.
PubMed 37781125Gunalan E, Yaba A, Yilmaz B. The effect of nutrient supplementation in the management of polycystic ovary syndrome-associated metabolic dysfunctions: A critical review. J Turk Ger Gynecol Assoc. 2018 Nov 15;19(4):220-232. doi: 10.4274/jtgga.2018.0077. Epub 2018 Oct 9.
PubMed 30299265Carboni L. Active Folate Versus Folic Acid: The Role of 5-MTHF (Methylfolate) in Human Health. Integr Med (Encinitas). 2022 Jul;21(3):36-41. No abstract available.
PubMed 35999905Florou P, Anagnostis P, Theocharis P, Chourdakis M, Goulis DG. Does coenzyme Q10 supplementation improve fertility outcomes in women undergoing assisted reproductive technology procedures? A systematic review and meta-analysis of randomized-controlled trials. J Assist Reprod Genet. 2020 Oct;37(10):2377-2387. doi: 10.1007/s10815-020-01906-3. Epub 2020 Aug 7.
PubMed 32767206Guarano A, Capozzi A, Cristodoro M, Di Simone N, Lello S. Alpha Lipoic Acid Efficacy in PCOS Treatment: What Is the Truth? Nutrients. 2023 Jul 19;15(14):3209. doi: 10.3390/nu15143209.
PubMed 37513627Nasiadek M, Stragierowicz J, Klimczak M, Kilanowicz A. The Role of Zinc in Selected Female Reproductive System Disorders. Nutrients. 2020 Aug 16;12(8):2464. doi: 10.3390/nu12082464.
PubMed 32824334
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled Study Evaluating the Impact of Milamend on Quality of Life and Hormonal Health in Women With Self-Reported Symptoms Associated With Polycystic Ovary Syndrome (PCOS)
- ClinicalTrials.gov ID
- NCT07764328
- Acronym / sponsor ID
- PS27
- Conditions
- Polycystic Ovarian Syndrome (PCOS)
- Keywords
- Polycystic Ovarian Syndrome, PCOS, Quality of Life, Hormonal Health, Oligomenorrhea, hyperandrogenism
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 225 participants (estimated)
- Lead sponsor
- Mila Mend Inc.Industry (pharma, biotech, devices)
- Collaborators
- People Science, Inc.
- Study start
- 23 Dec 2025 (actual)
- Primary completion
- 27 Oct 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 13 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo Arm | Placebo comparator | Dietary Supplement: PlaceboControl Arm using the placebo |
| Study Product Arm | Experimental | Dietary Supplement: A dietary supplement powder for womenExperimental study arm will use the Milamend Hormone Balance supplement |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (13 listed)
- 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
Key exclusion criteria (24 listed)
- 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:
- Other Illnesses or Conditions: Participants who have the following comorbidities or gastrointestinal illnesses are excluded:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| A dietary supplement powder for womenAlso: Hormone Balance supplement1 scoop/day mixed with ≥8 oz water for the first 3 days at study start and then increase to 1 scoop twice daily (AM/PM) with food. | Dietary supplement | Study Product Arm |
| PlaceboAlso: Hormone Balance Supplement Placebo1 scoop/day mixed with ≥8 oz water for the first 3 days at study start and then increase to 1 scoop twice daily (AM/PM) with food. | Dietary supplement | Placebo Arm |
Primary outcome
Quality of Life Impact
Time frame: 13 weeks
To evaluate the impact of Milamend product on quality of life associated with PCOS symptoms. Change in health-related quality of life score between placebo and study product group as measured by the PCOS-QOL. Baseline will be compared as well.
7 secondary outcomes
Menstrual Cycle Frequency, Function and Length Impact
Time frame: 12 weeks
Menstrual Cycle Symptoms Impact
Time frame: 12 weeks
General Well-Being Impact
Time frame: 13 weeks
Impact on Anxiety
Time frame: 13 weeks
Body Image Impact
Time frame: 13 weeks
Hormone and Metabolic Blood Marker Impact
Time frame: Baseline to Week 12
Safety and Tolerability Assessment
Time frame: 12 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2026.
- BackgroundPDF. Accessed September 3, 2025. https://www.europeanreview.org/wp/wp-content/uploads/5512-5521.pdf
- Background: PubMed 21622125Mao X, Zeng X, Qiao S, Wu G, Li D. Specific roles of threonine in intestinal mucosal integrity and barrier function. Front Biosci (Elite Ed). 2011 Jun 1;3(4):1192-200. doi: 10.2741/e322.
- Background: PubMed 21421912Finlay D, Cantrell D. The coordination of T-cell function by serine/threonine kinases. Cold Spring Harb Perspect Biol. 2011 Jan 1;3(1):a002261. doi: 10.1101/cshperspect.a002261.
- Background: PubMed 33804088Roth W, Zadeh K, Vekariya R, Ge Y, Mohamadzadeh M. Tryptophan Metabolism and Gut-Brain Homeostasis. Int J Mol Sci. 2021 Mar 15;22(6):2973. doi: 10.3390/ijms22062973.
- Background: PubMed 38287831Anderson G. Polycystic Ovary Syndrome Pathophysiology: Integrating Systemic, CNS and Circadian Processes. Front Biosci (Landmark Ed). 2024 Jan 18;29(1):24. doi: 10.31083/j.fbl2901024.
- Background: PubMed 36746677Gong Y, Jiang T, He H, Wang Y, Wu GL, Shi Y, Cai Q, Xiong CL, Shen R, Li J. Effects of carnitine on glucose and lipid metabolic profiles and fertility outcomes in women with polycystic ovary syndrome: A systematic review and meta-analysis. Clin Endocrinol (Oxf). 2023 May;98(5):682-691. doi: 10.1111/cen.14885. Epub 2023 Feb 17.
- Background: PubMed 19583806Papachroni KK, Piperi C, Levidou G, Korkolopoulou P, Pawelczyk L, Diamanti-Kandarakis E, Papavassiliou AG. Lysyl oxidase interacts with AGE signalling to modulate collagen synthesis in polycystic ovarian tissue. J Cell Mol Med. 2010 Oct;14(10):2460-9. doi: 10.1111/j.1582-4934.2009.00841.x.
- Background: PubMed 26658589Unni SN, Lakshman LR, Vaidyanathan K, Subhakumari KN, Menon NL. Alterations in the levels of plasma amino acids in polycystic ovary syndrome--A pilot study. Indian J Med Res. 2015 Nov;142(5):549-54. doi: 10.4103/0971-5916.171281.
- Background: PubMed 28498331Kim MH, Kim H. The Roles of Glutamine in the Intestine and Its Implication in Intestinal Diseases. Int J Mol Sci. 2017 May 12;18(5):1051. doi: 10.3390/ijms18051051.
- Background: PubMed 37781125Wang P, Chen B, Huang Y, Li J, Cao D, Chen Z, Li J, Ran B, Yang J, Wang R, Wei Q, Dong Q, Liu L. Selenium intake and multiple health-related outcomes: an umbrella review of meta-analyses. Front Nutr. 2023 Sep 13;10:1263853. doi: 10.3389/fnut.2023.1263853. eCollection 2023.
- Background: PubMed 30299265Gunalan E, Yaba A, Yilmaz B. The effect of nutrient supplementation in the management of polycystic ovary syndrome-associated metabolic dysfunctions: A critical review. J Turk Ger Gynecol Assoc. 2018 Nov 15;19(4):220-232. doi: 10.4274/jtgga.2018.0077. Epub 2018 Oct 9.
- Background: PubMed 35999905Carboni L. Active Folate Versus Folic Acid: The Role of 5-MTHF (Methylfolate) in Human Health. Integr Med (Encinitas). 2022 Jul;21(3):36-41. No abstract available.
- Individual participant dataSharing planned: Undecided
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Enrolling by invitation
Nutrition Intervention for Women With Polycystic Ovary Syndrome
PCOS- Polycystic Ovary Syndrome, Nutrition Intervention
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing A dietary supplement powder for women in people with Polycystic Ovarian Syndrome (PCOS), run by Mila Mend Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Noah Craft, M.D., Ph.D (213-328-0919, noah@peoplescience.health), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of Life Impact (time frame: 13 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07764328, which also lists 18 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Aug 2026.