Lactobacillus Rhamnosus and PCOS Treatment

Study Overview
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Brief Summary
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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.

Official Title
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The Effect of Lactobacillus Rhamnosus Supplementation on Body Mass, Hyperandrogenism and Insulin Resistance in Overweight and Obese Polycystic Ovary Syndrome Women - Randomized Nutritional Study

Conditions
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Obesity, Insulin Resistance, Polycystic Ovary Syndrome, Hyperandrogenism

Intervention / Treatment
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* Dietary Supplement: Lactobacillus group
* Dietary Supplement: Dietary group


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Dietary group<br>A diet based on general recommendations for people with insulin resistance for 20 weeks. | Dietary Supplement: Dietary group<br>* Nutritional intervention focused on the treatment of insulin resistance (35 subjects).<br>|
| Experimental: Lactobacillus rhamnosus group<br>Lactobacillus rhamnosus for 20 weeks, (2x 6×10 9 CFU/per capsulex); A diet based on general recommendations for people with insulin resistance. | Dietary Supplement: Lactobacillus group<br>* Nutrition intervention focused on the treatment of insulin resistance + Lactobacillus rhamnosus supplementation (6x10 9 of lactobacillus rhamnosus x 2 times a day) (35 people).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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). | 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). | 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). | 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). | 20 weeks | 
| Free androgen index FAI | Results of testosterone level and SHBG level will be combined to report FAI index (index of free androgen). | 20 weeks | 
| Body weight | Body weight (kg) will be assessment at baseline and after 20 weeks of the intervention. | 20 weeks | 
| Body height | Body height (cm) will be assessment at baseline of the intervention. | Baseline | 
| Body composition | Fat mass (%), fat free mass (%) will be assessment at baseline and after 20 weeks of the intervention. | 20 weeks | 
| Blood lipid profile: cholesterole | Cholesterole (mg/dL) will be measured at baseline and after 20 weeks of the intervention | 20 weeks | 
| Blood lipid profile: triglicerydes | Triglicerydes (mg/dL) will be measured at baseline and after 20 weeks of the intervention | 20 weeks | 
| Blood lipid profile: high density lipoprotein | High density lipoprotein HDL (mg/dL) will be measured at baseline and after 20 weeks of the intervention | 20 weeks | 
| Blood lipid profile: low density lipoprotein | Low density lipoprotein LDL (mg/dL) will be measured at baseline and after 20 weeks of the intervention | 20 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of qualitative and quantitative of the microbiome | Qualitative and quantitative determination of the composition of gut microbiota will be assessment at baseline and after 20 weeks of the intervention | 20 weeks | 
| Assessment of B-glucuronidase and B-glucosiadase activity | B-glucuronidase and B-glucosiadase activity in stoolen sample will be assessment at baseline and after 20 weeks of the intervention | 20 weeks | 
| Assessment of short-chain fatty acids | Assessment of short-chain fatty acids will be assessment at baseline and after 20 weeks of the intervention | 20 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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probiotic, Lactobacillus rhamnosus, Polycystic Ovary Syndrome, insulin resistance, nutrition intervention