Lactobacillus Rhamnosus and PCOS Treatment

Poznan University of Life Sciences80 enrolled

Overview

The effect of Lactobacillus rhamnosus supplementation on body weight, hyperandrogenism and insulin resistance in overweight and obesity women with Polycystic Ovary Syndrome will be analysed.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Insulin Resistance Polycystic Ovary Syndrome Hyperandrogenism Obesity

Interventions

Lactobacillus groupDIETARY_SUPPLEMENT

Nutrition intervention focused on the treatment of insulin resistance + Lactobacillus rhamnosus supplementation (6x10 9 of lactobacillus rhamnosus x 2 times a day) (35 people).

Dietary groupDIETARY_SUPPLEMENT

Nutritional intervention focused on the treatment of insulin resistance (35 subjects).

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 40 Years

Medical Language ↔ Plain English

Inclusion criteria: * patients diagnosed with PCOS, * BMI\> 28 kg/m2 (overweight or obesity), * patients not participating in other similar research programs at the same time, * no previous operations on ovaries such as: laparoscopy, ovarian cautery etc., * written agreement to take part in the research. Exlusion criteria: * the use of antibiotics or probiotics within 6 months before the start of the experiment, * the use of pharmacological agents or hormones that may affect the course of the menstrual cycle or metabolic rate within 3 months, * the use of medicament that may affect on carbohydrate metabolism within 4 weeks, * failure to comply with dietary recommendations established during the nutritional intervention, * the use of weight loss supplements during the study, * clinical diagnosis of digestive disease (for example: irritable bowel syndrome, ulcerative colitis, Crohn's disease, celiac disease), * pregnancy and breast feeding.

Locations (1)

Poznan University of Life Sciences

Poznan, Poland

Outcomes

Primary Outcomes

Insulin Resistance

Fasting insulin concentration (uU/ml) will be measured before and after 2 hours of 75g glucose drink. Insulin resistance will be measured before and after 20 weeks of the intervention.

Time frame: 20 weeks

Oral glucose test OGTT

Fasting glucose concentration (mg/dL) will be measured before and after 2 hours of 75g glucose drink. OGTT will be measured before and after 20 weeks of the intervention. Fating glucose and fasting insulin concentrations will be combined to report HOMA-IR index (homeostatic model assessment of insulin resistance).

Time frame: 20 weeks

Testosterone

Testosterone (ng/mL) concentrations will measured at baseline and after 20 weeks of the intervention. Results of testosterone level and SHBG level will be combined to report FAI index (index of free androgen).

Time frame: 20 weeks

DHEA-SO4

DHEA-SO4 (umol/L) concentrations will measured at baseline and after 20 weeks of the intervention. Results of testosterone level and SHBG level will be combined to report FAI index (index of free androgen).

Time frame: 20 weeks

SHBG

SHBG (nmol/L) concentrations will measured at baseline and after 20 weeks of the intervention. Results of testosterone level and SHBG level will be combined to report FAI index (index of free androgen).

Time frame: 20 weeks

Free androgen index FAI

Results of testosterone level and SHBG level will be combined to report FAI index (index of free androgen).

Time frame: 20 weeks

Body weight

Body weight (kg) will be assessment at baseline and after 20 weeks of the intervention.

Data from ClinicalTrials.gov

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Lactobacillus Rhamnosus and PCOS Treatment

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes