Lactobacillus Rhamnosus and PCOS Treatment

Not Applicable

Completed

• Conditions: Hyperandrogenism; Polycystic Ovary Syndrome; Obesity; Insulin Resistance
• Interventions: Dietary Supplement: Lactobacillus group; Dietary Supplement: Dietary group

• Registration Number: NCT03902301
• Lead Sponsor: Poznan University of Life Sciences

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-04-01
• Study First Submitted: 2019-03-11
• Study First Submitted QC: 2019-04-02
• Study First Posted: 2019-04-04
• Primary Completion: 2020-12-31
• Study Completion: 2020-12-31
• Status Verified: 2022-04
• Last Update Submitted: 2022-04-19
• Last Update Posted: 2022-04-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 80

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Lactobacillus rhamnosus group	Lactobacillus 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 group	Dietary group	A diet based on general recommendations for people with insulin resistance for 20 weeks.

Primary Outcome Measures

Name	Time	Method
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).
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).
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: low density lipoprotein	20 weeks	Low density lipoprotein LDL (mg/dL) will be measured at baseline and after 20 weeks of the intervention
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).
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).
Free androgen index FAI	20 weeks	Results of testosterone level and SHBG level will be combined to report FAI index (index of free androgen).
Blood lipid profile: triglicerydes	20 weeks	Triglicerydes (mg/dL) will be measured at baseline and after 20 weeks of the intervention
Body height	Baseline	Body height (cm) will be assessment at baseline of the intervention.
Body weight	20 weeks	Body weight (kg) will be assessment 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

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Poznan University of Life Sciences; 🇵🇱 Poznan, Poland