The Effect of Lactobacillus Rhamnosus Supplementation on Body Mass, Hyperandrogenism and Insulin Resistance in Overweight and Obese Polycystic Ovary Syndrome Women - Randomized Nutritional Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 80
- Locations
- 2
- Primary Endpoint
- Testosterone
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Investigator)
Eligibility Criteria
- Ages
- 18 Years to 40 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
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.
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Testosterone
Time Frame: 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
Time Frame: 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
Time Frame: 20 weeks
Fat mass (%), fat free mass (%) will be assessment at baseline and after 20 weeks of the intervention.
Blood lipid profile: cholesterole
Time Frame: 20 weeks
Cholesterole (mg/dL) will be measured at baseline and after 20 weeks of the intervention
Blood lipid profile: low density lipoprotein
Time Frame: 20 weeks
Low density lipoprotein LDL (mg/dL) will be measured at baseline and after 20 weeks of the intervention
Insulin Resistance
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 20 weeks
Results of testosterone level and SHBG level will be combined to report FAI index (index of free androgen).
Blood lipid profile: triglicerydes
Time Frame: 20 weeks
Triglicerydes (mg/dL) will be measured at baseline and after 20 weeks of the intervention
Body height
Time Frame: Baseline
Body height (cm) will be assessment at baseline of the intervention.
Body weight
Time Frame: 20 weeks
Body weight (kg) will be assessment at baseline and after 20 weeks of the intervention.
Blood lipid profile: high density lipoprotein
Time Frame: 20 weeks
High density lipoprotein HDL (mg/dL) will be measured at baseline and after 20 weeks of the intervention
Secondary Outcomes
- Assessment of qualitative and quantitative of the microbiome(20 weeks)
- Assessment of B-glucuronidase and B-glucosiadase activity(20 weeks)
- Assessment of short-chain fatty acids(20 weeks)
Investigators
Karolina Łagowska
Principal Investigator (dr inż)
Poznan University of Life Sciences