ProjectPCOS: Lactobacillus Rhamnosus and PCOS Treatment
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: Dietary group A diet based on general recommendations for people with insulin resistance for 20 weeks. |
Dietary Supplement: Dietary group
Nutritional intervention focused on the treatment of insulin resistance (35 subjects).
|
| Experimental: Lactobacillus rhamnosus group 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
Nutrition intervention focused on the treatment of insulin resistance + Lactobacillus rhamnosus supplementation (6x10 9 of lactobacillus rhamnosus x 2 times a day) (35 people).
|
Outcome Measures
Primary Outcome Measures
- Insulin Resistance [20 weeks]
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.
- Oral glucose test OGTT [20 weeks]
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).
- Testosterone [20 weeks]
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).
- DHEA-SO4 [20 weeks]
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).
- SHBG [20 weeks]
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).
- Free androgen index FAI [20 weeks]
Results of testosterone level and SHBG level will be combined to report FAI index (index of free androgen).
- Body weight [20 weeks]
Body weight (kg) will be assessment at baseline and after 20 weeks of the intervention.
- Body height [Baseline]
Body height (cm) will be assessment at baseline of the intervention.
- Body composition [20 weeks]
Fat mass (%), fat free mass (%) will be assessment at baseline and after 20 weeks of the intervention.
- Blood lipid profile: cholesterole [20 weeks]
Cholesterole (mg/dL) will be measured at baseline and after 20 weeks of the intervention
- Blood lipid profile: triglicerydes [20 weeks]
Triglicerydes (mg/dL) will be measured at baseline and after 20 weeks of the intervention
- Blood lipid profile: high density lipoprotein [20 weeks]
High density lipoprotein HDL (mg/dL) will be measured at baseline and after 20 weeks of the intervention
- Blood lipid profile: low density lipoprotein [20 weeks]
Low density lipoprotein LDL (mg/dL) will be measured at baseline and after 20 weeks of the intervention
Secondary Outcome Measures
- Assessment of qualitative and quantitative of the microbiome [20 weeks]
Qualitative and quantitative determination of the composition of gut microbiota will be assessment at baseline and after 20 weeks of the intervention
- Assessment of B-glucuronidase and B-glucosiadase activity [20 weeks]
B-glucuronidase and B-glucosiadase activity in stoolen sample will be assessment at baseline and after 20 weeks of the intervention
- Assessment of short-chain fatty acids [20 weeks]
Assessment of short-chain fatty acids will be assessment at baseline and after 20 weeks of the intervention
Eligibility Criteria
Criteria
Inclusion criteria:
-
patients diagnosed with PCOS,
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BMI> 28 kg/m2 (overweight or obesity),
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patients not participating in other similar research programs at the same time,
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no previous operations on ovaries such as: laparoscopy, ovarian cautery etc.,
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written agreement to take part in the research.
Exlusion criteria:
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the use of antibiotics or probiotics within 6 months before the start of the experiment,
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the use of pharmacological agents or hormones that may affect the course of the menstrual cycle or metabolic rate within 3 months,
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the use of medicament that may affect on carbohydrate metabolism within 4 weeks,
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failure to comply with dietary recommendations established during the nutritional intervention,
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the use of weight loss supplements during the study,
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clinical diagnosis of digestive disease (for example: irritable bowel syndrome, ulcerative colitis, Crohn's disease, celiac disease),
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pregnancy and breast feeding.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Poznan University of Life Sciences | Poznan | Poland | 60-624 |
Sponsors and Collaborators
- Poznan University of Life Sciences
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- Project PCOS