Lactobacillus Rhamnosus and PCOS Treatment

Obesity Clinical Trial

— ProjectPCOS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03902301
• Other study ID #: Project PCOS
• Status: Completed
• Phase: N/A
• Start date: April 1, 2018
• Est. completion date: December 31, 2020

Study information

• Verified date: April 2022
• Source: Poznan University of Life Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: December 31, 2020
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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.

Related Conditions & MeSH terms

• Hyperandrogenism
• Insulin Resistance
• Obesity
• Polycystic Ovary Syndrome
• Syndrome

Intervention

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

Locations

Country	Name	City	State
Poland	Poznan University of Life Sciences	Poznan

Sponsors (1)

Lead Sponsor	Collaborator
Poznan University of Life Sciences

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	Free androgen index FAI	Results of testosterone level and SHBG level will be combined to report FAI index (index of free androgen).	20 weeks
Primary	Body weight	Body weight (kg) will be assessment at baseline and after 20 weeks of the intervention.	20 weeks
Primary	Body height	Body height (cm) will be assessment at baseline of the intervention.	Baseline
Primary	Body composition	Fat mass (%), fat free mass (%) will be assessment at baseline and after 20 weeks of the intervention.	20 weeks
Primary	Blood lipid profile: cholesterole	Cholesterole (mg/dL) will be measured at baseline and after 20 weeks of the intervention	20 weeks
Primary	Blood lipid profile: triglicerydes	Triglicerydes (mg/dL) will be measured at baseline and after 20 weeks of the intervention	20 weeks
Primary	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
Primary	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	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
Secondary	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
Secondary	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