Clinical trial · Interventional
Study of the Effect of a Nutritional Supplement on Microbiota, Metabolic Control, Inflammatory Profile, and Quality of Life in Patients With Polycystic Ovary Syndrome.
Study of the Effect of a Nutritional Supplement on Microbiota, Metabolic Control, Inflammatory Profile, and Quality of Life in Patients With Polycystic Ovary Syndrome
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Polycystic Ovary Syndrome (PCOS) is a complex endocrine-metabolic disorder characterized by elevated androgen levels due to ovarian overproduction. Although the pathophysiology of PCOS is not fully understood, it is estimated that insulin resistance (IR) occurs in 70-80% of PCOS cases, which may contribute to hyperandrogenism in affected women. Women with PCOS and IR are more likely to develop metabolic syndrome, increasing the risk of diabetes, cardiovascular diseases, lipid profile deterioration, elevated inflammation levels, and greater oxidative stress. The symptoms of PCOS are varied and differ among patients. Common symptoms include androgenic alopecia, hirsutism, acne, abdominal fat accumulation, and fertility issues. These physical manifestations and related problems have been associated with reduced quality of life and self-esteem in these women. The symptoms of PCOS can be improved through lifestyle changes aimed at enhancing insulin sensitivity, such as proper nutrition and regular physical exercise. Some supplements, such as a combination of Myo-inositol and D-chiro-inositol in a 40:1 ratio, are being used to support the management of PCOS because they appear to improve insulin sensitivity, as well as reduce underlying inflammation and oxidative stress. To determine whether nutritional intervention combined with inositol supplementation improves PCOS symptoms, various variables will be analyzed to assess improvements in oxidative stress markers, inflammation, lipid profile, hormonal profile, and microbiota. Additionally, if the metabolic profile improves, it is hypothesized that this could also enhance quality of life and self-esteem.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Metabolic Syndrome | — | UNRESOLVED | — |
| Polycystic Ovary Syndrome | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Ovapro (Lifepro) | Dietary Supplement | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- ACTIVE_COMPARATOR
- label
- Dietary supplement in PCOS
- description
- Subjects will recieve nutritional intervention by a registered dietitian and a supplement containing inositol, vitamin D, zinc, and curcumin for 3 months. The dietary intervention consists of healthy dietary recommendations and hipocaloric diet if needed (overweight, obesity).
- interventionNames
- Dietary Supplement: Ovapro (Lifepro)
- type
- PLACEBO_COMPARATOR
- label
- Placebo in PCOS
- description
- Subjects will recieve nutritional intervention by a registered dietitian and a supplement containing yellow colorant for 3 months. The dietary intervention consists of healthy dietary recommendations and hipocaloric diet if needed (overweight, obesity).
- interventionNames
- Dietary Supplement: Ovapro (Lifepro)
- type
- NO_INTERVENTION
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 45 Years
Show eligibility criteria text
Inclusion Criteria: * Patients aged between 18 and 45 years. * Patients diagnosed with PCOS using the AE-PCOS diagnostic criteria (2009). * Patients who agree to participate in the study and sign the informed consent form after reading it. Exclusion Criteria: * Having been treated with medication or supplementation aimed at improving PCOS prior to the study (e.g., metformin, hormonal therapy, inositol, etc.). * Suffering from an infectious, hematological, inflammatory, or autoimmune disease. * Having a severe organic disease. * Suffering from cardiovascular disease (heart attack, ischemia, thromboembolism). * Diabetes Mellitus. * Severe arterial hypertension. * Alcoholism. * Active smoking.
References
Publications (14)
- BACKGROUNDSander VA, Hapon MB, Sicaro L, Lombardi EP, Jahn GA, Motta AB. Alterations of folliculogenesis in women with polycystic ovary syndrome. J Steroid Biochem Mol Biol. 2011 Mar;124(1-2):58-64. doi: 10.1016/j.jsbmb.2011.01.008. Epub 2011 Jan 22. PMID 21262361
- BACKGROUNDSachdeva G, Gainder S, Suri V, Sachdeva N, Chopra S. Obese and Non-obese Polycystic Ovarian Syndrome: Comparison of Clinical, Metabolic, Hormonal Parameters, and their Differential Response to Clomiphene. Indian J Endocrinol Metab. 2019 Mar-Apr;23(2):257-262. doi: 10.4103/ijem.IJEM_637_18. PMID 31161114
- BACKGROUNDPanidis D, Tziomalos K, Misichronis G, Papadakis E, Betsas G, Katsikis I, Macut D. Insulin resistance and endocrine characteristics of the different phenotypes of polycystic ovary syndrome: a prospective study. Hum Reprod. 2012 Feb;27(2):541-9. doi: 10.1093/humrep/der418. Epub 2011 Dec 5. PMID 22144419
- BACKGROUNDNavarro G, Allard C, Xu W, Mauvais-Jarvis F. The role of androgens in metabolism, obesity, and diabetes in males and females. Obesity (Silver Spring). 2015 Apr;23(4):713-9. doi: 10.1002/oby.21033. Epub 2015 Mar 6. PMID 25755205
- BACKGROUNDJamil AS, Alalaf SK, Al-Tawil NG, Al-Shawaf T. A case-control observational study of insulin resistance and metabolic syndrome among the four phenotypes of polycystic ovary syndrome based on Rotterdam criteria. Reprod Health. 2015 Jan 16;12:7. doi: 10.1186/1742-4755-12-7. PMID 25595199
- BACKGROUNDToosy S, Sodi R, Pappachan JM. Lean polycystic ovary syndrome (PCOS): an evidence-based practical approach. J Diabetes Metab Disord. 2018 Nov 13;17(2):277-285. doi: 10.1007/s40200-018-0371-5. eCollection 2018 Dec. PMID 30918863
- BACKGROUNDSzczuko M, Skowronek M, Zapalowska-Chwyc M, Starczewski A. Quantitative assessment of nutrition in patients with polycystic ovary syndrome (PCOS). Rocz Panstw Zakl Hig. 2016;67(4):419-426.