Lactobacillus Rhamnosus and PCOS Treatment (ProjectPCOS)
Primary Purpose
Insulin Resistance, Polycystic Ovary Syndrome, Hyperandrogenism
Status
Completed
Phase
Not Applicable
Locations
Poland
Study Type
Interventional
Intervention
Lactobacillus group
Dietary group
Sponsored by
About this trial
This is an interventional treatment trial for Insulin Resistance focused on measuring Lactobacillus rhamnosus, Polycystic Ovary Syndrome, insulin resistance, nutrition intervention, probiotic
Eligibility Criteria
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.
Sites / Locations
- Poznan University of Life Sciences
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Dietary group
Lactobacillus rhamnosus group
Arm Description
A diet based on general recommendations for people with insulin resistance for 20 weeks.
Lactobacillus rhamnosus for 20 weeks, (2x 6×10 9 CFU/per capsulex); A diet based on general recommendations for people with insulin resistance.
Outcomes
Primary Outcome Measures
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.
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).
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).
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).
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).
Free androgen index FAI
Results of testosterone level and SHBG level will be combined to report FAI index (index of free androgen).
Body weight
Body weight (kg) will be assessment at baseline and after 20 weeks of the intervention.
Body height
Body height (cm) will be assessment at baseline of the intervention.
Body composition
Fat mass (%), fat free mass (%) will be assessment at baseline and after 20 weeks of the intervention.
Blood lipid profile: cholesterole
Cholesterole (mg/dL) will be measured at baseline and after 20 weeks of the intervention
Blood lipid profile: triglicerydes
Triglicerydes (mg/dL) will be measured at baseline and after 20 weeks of the intervention
Blood lipid profile: high density lipoprotein
High density lipoprotein HDL (mg/dL) will be measured at baseline and after 20 weeks of the intervention
Blood lipid profile: low density lipoprotein
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
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
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
Assessment of short-chain fatty acids will be assessment at baseline and after 20 weeks of the intervention
Full Information
NCT ID
NCT03902301
First Posted
March 11, 2019
Last Updated
April 19, 2022
Sponsor
Poznan University of Life Sciences
1. Study Identification
Unique Protocol Identification Number
NCT03902301
Brief Title
Lactobacillus Rhamnosus and PCOS Treatment
Acronym
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
Study Type
Interventional
2. Study Status
Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
April 1, 2018 (Actual)
Primary Completion Date
December 31, 2020 (Actual)
Study Completion Date
December 31, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Poznan University of Life Sciences
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Insulin Resistance, Polycystic Ovary Syndrome, Hyperandrogenism, Obesity
Keywords
Lactobacillus rhamnosus, Polycystic Ovary Syndrome, insulin resistance, nutrition intervention, probiotic
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
80 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Dietary group
Arm Type
Active Comparator
Arm Description
A diet based on general recommendations for people with insulin resistance for 20 weeks.
Arm Title
Lactobacillus rhamnosus group
Arm Type
Experimental
Arm Description
Lactobacillus rhamnosus for 20 weeks, (2x 6×10 9 CFU/per capsulex); A diet based on general recommendations for people with insulin resistance.
Intervention Type
Dietary Supplement
Intervention Name(s)
Lactobacillus group
Intervention Description
Nutrition intervention focused on the treatment of insulin resistance + Lactobacillus rhamnosus supplementation (6x10 9 of lactobacillus rhamnosus x 2 times a day) (35 people).
Intervention Type
Dietary Supplement
Intervention Name(s)
Dietary group
Intervention Description
Nutritional intervention focused on the treatment of insulin resistance (35 subjects).
Primary Outcome Measure Information:
Title
Insulin Resistance
Description
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.
Time Frame
20 weeks
Title
Oral glucose test OGTT
Description
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).
Time Frame
20 weeks
Title
Testosterone
Description
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).
Time Frame
20 weeks
Title
DHEA-SO4
Description
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).
Time Frame
20 weeks
Title
SHBG
Description
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).
Time Frame
20 weeks
Title
Free androgen index FAI
Description
Results of testosterone level and SHBG level will be combined to report FAI index (index of free androgen).
Time Frame
20 weeks
Title
Body weight
Description
Body weight (kg) will be assessment at baseline and after 20 weeks of the intervention.
Time Frame
20 weeks
Title
Body height
Description
Body height (cm) will be assessment at baseline of the intervention.
Time Frame
Baseline
Title
Body composition
Description
Fat mass (%), fat free mass (%) will be assessment at baseline and after 20 weeks of the intervention.
Time Frame
20 weeks
Title
Blood lipid profile: cholesterole
Description
Cholesterole (mg/dL) will be measured at baseline and after 20 weeks of the intervention
Time Frame
20 weeks
Title
Blood lipid profile: triglicerydes
Description
Triglicerydes (mg/dL) will be measured at baseline and after 20 weeks of the intervention
Time Frame
20 weeks
Title
Blood lipid profile: high density lipoprotein
Description
High density lipoprotein HDL (mg/dL) will be measured at baseline and after 20 weeks of the intervention
Time Frame
20 weeks
Title
Blood lipid profile: low density lipoprotein
Description
Low density lipoprotein LDL (mg/dL) will be measured at baseline and after 20 weeks of the intervention
Time Frame
20 weeks
Secondary Outcome Measure Information:
Title
Assessment of qualitative and quantitative of the microbiome
Description
Qualitative and quantitative determination of the composition of gut microbiota will be assessment at baseline and after 20 weeks of the intervention
Time Frame
20 weeks
Title
Assessment of B-glucuronidase and B-glucosiadase activity
Description
B-glucuronidase and B-glucosiadase activity in stoolen sample will be assessment at baseline and after 20 weeks of the intervention
Time Frame
20 weeks
Title
Assessment of short-chain fatty acids
Description
Assessment of short-chain fatty acids will be assessment at baseline and after 20 weeks of the intervention
Time Frame
20 weeks
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Poznan University of Life Sciences
City
Poznan
ZIP/Postal Code
60-624
Country
Poland
12. IPD Sharing Statement
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Lactobacillus Rhamnosus and PCOS Treatment
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