Study of the Effect of a Nutritional Supplement on Microbiota, Metabolic Control, Inflammatory Profile, and Quality of Life in Patients With Polycystic Ovary Syndrome.

NCT06551285 | Recruiting

• 1 other identifier: CEIm: 131/23
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

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

Polycystic Ovary Syndrome; Metabolic Syndrome

Keywords

Insulin resistance; Inflammation; Oxidative Stress; Intestinal microbiota

Outcome Measures

Primary Outcomes (2)

• Verify that nutritional intervention and inositol supplementation improve the symptoms of PCOS.

  To assess if there is an improvement in PCOS symptoms, both PCOSQ and Ferriman-Gallwey test and regularity of menstrual cycle will be evaluated. PCOSQ result must be assessed as 7-point scales in which 7 represents optimal function and 1 represents the poorest function. Ferriman-Gallway test gives a total score, which can range from 0 to 36. A score of ≥8 si considered a sign of androgen excess in caucausian women; a score of 8-15 indicates mild hirsutism, and \>15 indicates moderate or severe hirsutism. The classification of patients between PCOS or healthy will be carried out using Rotterdam criteria.

  5 years

• Evaluate the differences in the diversity of the intestinal microbiota depending on whether patients present PCOS or not.

  To asses the differences in alpha-diversity of the intestinal microbiota in both groups, it will be evaluated whether there are significant differences between the Shannon indices of the two groups.

  5 years

Secondary Outcomes (12)

• Evaluate significant changes in body fat mass percentage after the dietetic intervention and dietetic supplement.

  3 years

• Assess significant changes in high-sensitivity C-reactive protein (hs-CRP) as an inflammatory parameter after the dietary intervention and dietetic supplement.

  3 years

• Evaluate significant changes in C3 protein as an inflammatory parameter after the dietetic intervention and dietetic supplement.

  3 years

• Evaluate significant changes in interleukin 1-beta (IL-1B) levels as a pro-inflammatory molecule after the dietetic intervention and dietetic supplement.

  3 years

• Evaluate significant changes in interleukin 6 (IL-6) levels as a pro-inflammatory molecule after the dietetic intervention and dietetic supplement.

  3 years

Study Arms (3)

Dietary supplement in PCOS

ACTIVE COMPARATOR

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).

Dietary Supplement: Ovapro (Lifepro)

Placebo in PCOS

PLACEBO COMPARATOR

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).

Dietary Supplement: Ovapro (Lifepro)

No intervention in healthy subjects

NO INTERVENTION

Healthy subjects will not recieve supplement/placebo nor dietary intervention.

Interventions

Ovapro (Lifepro) DIETARY_SUPPLEMENT

Dietary supplement that contains inositol, vitamin D, zinc, and curcumin.

Dietary supplement in PCOS; Placebo in PCOS

Eligibility Criteria

• Age: 18 Years - 45 Years
• Gender Eligibility Details: Biological female gender.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Celia Bañuls: lead

Study Sites (1)

FISABIO

Valencia, Valencia, 46020, Spain

RECRUITING

Related Publications (14)

• Sander 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 BACKGROUND

• Sachdeva 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 BACKGROUND

• Panidis 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 BACKGROUND

• Navarro 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 BACKGROUND

• Jamil 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 BACKGROUND

• Toosy 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 BACKGROUND

• Szczuko 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.

  PMID: 27925712 BACKGROUND

• Yang Y, Deng H, Li T, Xia M, Liu C, Bu XQ, Li H, Fu LJ, Zhong ZH. The mental health of Chinese women with polycystic ovary syndrome is related to sleep disorders, not disease status. J Affect Disord. 2021 Mar 1;282:51-57. doi: 10.1016/j.jad.2020.12.084. Epub 2020 Dec 27.

  PMID: 33388474 BACKGROUND

• Mojaverrostami S, Asghari N, Khamisabadi M, Heidari Khoei H. The role of melatonin in polycystic ovary syndrome: A review. Int J Reprod Biomed. 2019 Dec 30;17(12):865-882. doi: 10.18502/ijrm.v17i12.5789. eCollection 2019 Dec.

  PMID: 31970309 BACKGROUND

• Jiao N, Baker SS, Nugent CA, Tsompana M, Cai L, Wang Y, Buck MJ, Genco RJ, Baker RD, Zhu R, Zhu L. Gut microbiome may contribute to insulin resistance and systemic inflammation in obese rodents: a meta-analysis. Physiol Genomics. 2018 Apr 1;50(4):244-254. doi: 10.1152/physiolgenomics.00114.2017. Epub 2018 Jan 26.

  PMID: 29373083 BACKGROUND

• Zhang Z, Bai L, Guan M, Zhou X, Liang X, Lv Y, Yi H, Zhou H, Liu T, Gong P, Sun J, Zhang L. Potential probiotics Lactobacillus casei K11 combined with plant extracts reduce markers of type 2 diabetes mellitus in mice. J Appl Microbiol. 2021 Oct;131(4):1970-1982. doi: 10.1111/jam.15061. Epub 2021 Apr 8.

  PMID: 33694236 BACKGROUND

• Bamberger C, Rossmeier A, Lechner K, Wu L, Waldmann E, Fischer S, Stark RG, Altenhofer J, Henze K, Parhofer KG. A Walnut-Enriched Diet Affects Gut Microbiome in Healthy Caucasian Subjects: A Randomized, Controlled Trial. Nutrients. 2018 Feb 22;10(2):244. doi: 10.3390/nu10020244.

  PMID: 29470389 BACKGROUND

• den Besten G, van Eunen K, Groen AK, Venema K, Reijngoud DJ, Bakker BM. The role of short-chain fatty acids in the interplay between diet, gut microbiota, and host energy metabolism. J Lipid Res. 2013 Sep;54(9):2325-40. doi: 10.1194/jlr.R036012. Epub 2013 Jul 2.

  PMID: 23821742 BACKGROUND

• Heimann E, Nyman M, Palbrink AK, Lindkvist-Petersson K, Degerman E. Branched short-chain fatty acids modulate glucose and lipid metabolism in primary adipocytes. Adipocyte. 2016 Oct 28;5(4):359-368. doi: 10.1080/21623945.2016.1252011. eCollection 2016 Oct-Dec.

  PMID: 27994949 BACKGROUND

MeSH Terms

Conditions

Polycystic Ovary Syndrome; Metabolic Syndrome; Insulin Resistance; Inflammation

Condition Hierarchy (Ancestors)

Ovarian Cysts; Cysts; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Gonadal Disorders; Endocrine System Diseases; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 31, 2024
• First Posted: August 13, 2024
• Study Start: February 1, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): May 31, 2029
• Last Updated: March 17, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)