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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dietary group | Active Comparator | A diet based on general recommendations for people with insulin resistance for 20 weeks. |
|
| Lactobacillus rhamnosus group | Experimental | Lactobacillus rhamnosus for 20 weeks, (2x 6×10 9 CFU/per capsulex); A diet based on general recommendations for people with insulin resistance. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lactobacillus group | Dietary 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). |
| 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 |
| 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 |
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Inclusion criteria:
Exlusion criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Poznan University of Life Sciences | Poznan | 60-624 | Poland |
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| ID | Term |
|---|---|
| D007333 | Insulin Resistance |
| D011085 | Polycystic Ovary Syndrome |
| D017588 | Hyperandrogenism |
| D009765 | Obesity |
| ID | Term |
|---|---|
| D006946 | Hyperinsulinism |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| Dietary group | Dietary Supplement | Nutritional intervention focused on the treatment of insulin resistance (35 subjects). |
|
| 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 |
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 |
| D010048 | Ovarian Cysts |
| D003560 | Cysts |
| D009369 | Neoplasms |
| D010049 | Ovarian Diseases |
| D000291 | Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D006058 | Gonadal Disorders |
| D004700 | Endocrine System Diseases |
| D058489 | 46, XX Disorders of Sex Development |
| D012734 | Disorders of Sex Development |
| D014564 | Urogenital Abnormalities |
| D047808 | Adrenogenital Syndrome |
| D052801 | Male Urogenital Diseases |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |