Study of the Effect of a Nutritional Supplement on Microbiota, Metabolic Control, Inflammatory Profile, and Quality of Life in Patients With Polycystic Ovary Syndrome.
NCT Number: NCT06551285
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Polycystic Ovary Syndrome|Metabolic Syndrome
Interventions: DIETARY_SUPPLEMENT: Ovapro (Lifepro)
Sponsor: Celia Bañuls
Sex: FEMALE
Age: ADULT
Enrollment: 120
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2024-02-01
Completion Date: 2029-05-31
Locations: FISABIO, Valencia, Comunidad Valenciana, 46020, Spain

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.

Primary Outcome Measures: 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 Outcome Measures: Evaluate significant changes in body fat mass percentage after the dietetic intervention and dietetic supplement., Percentage of body fat mass will be measured by bioelectrical impedance. It is considered to be high when ≥30% in women. A significant improvement will be considered when notable differences are observed in the mean values between groups measured through p-value (\<0.05) with a 95% confidence interval., 3 years|Assess significant changes in high-sensitivity C-reactive protein (hs-CRP) as an inflammatory parameter after the dietary intervention and dietetic supplement., Participants will be considered to have achieved an improvement in high-sensitivity C-reactive protein levels if they normalize its value (normality values defined between 0 and 1.69mg/dl)., 3 years|Evaluate significant changes in C3 protein as an inflammatory parameter after the dietetic intervention and dietetic supplement., Participants will be considered to have achieved an improvement in C3 protein if they normalize its value (normality values defined between 81 and 157mg/dl)., 3 years|Evaluate significant changes in interleukin 1-beta (IL-1B) levels as a pro-inflammatory molecule after the dietetic intervention and dietetic supplement., IL-1B levels will be measured using the Luminex® 200 analyzer system. A significant improvement will be considered when notable differences are observed in the mean values between groups measured through p-value (\<0.05) with a 95% confidence interval., 3 years|Evaluate significant changes in interleukin 6 (IL-6) levels as a pro-inflammatory molecule after the dietetic intervention and dietetic supplement., IL-6 levels will be measured using the Luminex® 200 analyzer system. A significant improvement will be considered when notable differences are observed in the mean values between groups measured through p-value (\<0.05) with a 95% confidence interval., 3 years|Evaluate significant changes in tumor necrosis factor alpha (TNF-alpha) levels as a pro-inflammatory molecule after the dietetic intervention and dietetic supplement., TNF-alpha levels will be measured using the Luminex® 200 analyzer system. A significant improvement will be considered when notable differences are observed in the mean values between groups measured through p-value (\<0.05) with a 95% confidence interval., 3 years|Assess significant changes in superoxide dismutase (SOD) levels after the dietetic intervention and dietetic supplement., Superoxide dismutase levels will be measured using the Luminex® 200 analyzer system. A significant improvement will be considered when notable differences are observed in the mean values between groups measured through p-value (\<0.05) with a 95% confidence interval., 3 years|Evaluate if there is a significant reduction after the dietetic intervention in total ROS levels., Total ROS levels will be assessed by a flow cytometry assay. A significant improvement will be considered when notable differences are observed in the mean values between groups measured through p-value (\<0.05) with a 95% confidence interval., 3 years|Assess if there is a significant reduction after the dietetic intervention in glutathione levels., Total glutathione levels will be assessed by a flow cytometry assay. A significant improvement will be considered when notable differences are observed in the mean values between groups measured through p-value (\<0.05) with a 95% confidence interval., 3 years|Analyze if there is a significant change after the dietetic intervention in total free radicals and superoxide levels., Total free radicals and superoxide content will be assessed by a flow cytometry assay. A significant improvement will be considered when notable differences are observed in the mean values between groups measured through p-value (\<0.05) with a 95% confidence interval., 3 years|Analyze if there is a significant reduction after the dietetic intervention in mitochondrial ROS production., Mitochondrial ROS production will be assessed by a flow cytometry assay. A significant improvement will be considered when notable differences are observed in the mean values between groups measured through p-value (\<0.05) with a 95% confidence interval., 3 years|Evaluate if there is a significant improvement after the dietetic intervention in mitochondrial membrane potential., Mitochondrial membrane potential will be assessed by a flow cytometry assay. A significant improvement will be considered when notable differences are observed in the mean values between groups measured through p-value (\<0.05) with a 95% confidence interval., 3 years