Lactobacillus Rhamnosus and PCOS Treatment (ProjectPCOS)

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

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.

Study Overview

• Status: Completed
• Conditions: Obesity; Polycystic Ovary Syndrome; Hyperandrogenism; Insulin Resistance
• Intervention / Treatment: Dietary supplement: Dietary group; Dietary supplement: Lactobacillus group

• Study Type: Interventional
• Enrollment (Actual): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Poland
  • Poznan, Poland, 60-624
    • Poznan University of Life Sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / 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).

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Poznan University of Life Sciences

Study record dates

Study Major Dates

• Study Start (ACTUAL): April 1, 2018
• Primary Completion (ACTUAL): December 31, 2020
• Study Completion (ACTUAL): December 31, 2020

Study Registration Dates

• First Submitted: March 11, 2019
• First Submitted That Met QC Criteria: April 2, 2019
• First Posted (ACTUAL): April 4, 2019

Study Record Updates

• Last Update Posted (ACTUAL): April 26, 2022
• Last Update Submitted That Met QC Criteria: April 19, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Keywords: probiotic; Polycystic Ovary Syndrome; insulin resistance; nutrition intervention; Lactobacillus rhamnosus
• Additional Relevant MeSH Terms: Pathologic Processes; Glucose Metabolism Disorders; Metabolic Diseases; Neoplasms; Endocrine System Diseases; Disease; Ovarian Cysts; Cysts; Ovarian Diseases; Adnexal Diseases; Gonadal Disorders; 46, XX Disorders of Sex Development; Disorders of Sex Development; Urogenital Abnormalities; Adrenogenital Syndrome; Congenital Abnormalities; Hyperinsulinism; Polycystic Ovary Syndrome; Hyperandrogenism; Syndrome; Insulin Resistance
• Other Study ID Numbers: Project PCOS

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No