An interventional study of Lactobacillus group and Dietary group in Insulin Resistance, Polycystic Ovary Syndrome and Hyperandrogenism, sponsored by Poznan University of Life Sciences. Completed at 1 site in Poland. Open to female participants aged 18 Years to 40 Years. Per ClinicalTrials.gov, last updated 2022-04-26.
Sponsored by Poznan University of Life Sciences · Not applicable, Interventional, and Treatment
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.
2,969 studies on the registry are indexed under Insulin Resistance; 338 are open to participants now.
This study's enrollment of 80 is above the median of 40 across 2,369 interventional studies indexed under Insulin Resistance.
Browse Insulin Resistance studies →Poznan University of Life Sciences is the lead sponsor of 25 studies on the registry; 5 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Inclusion criteria:
Exlusion criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A diet based on general recommendations for people with insulin resistance for 20 weeks.
Dietary Supplement: Dietary 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).
Nutritional intervention focused on the treatment of insulin resistance (35 subjects).
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.
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 20 weeks
Free androgen index FAI
Results of testosterone level and SHBG level will be combined to report FAI index (index of free androgen).
Time frame: 20 weeks
Body weight
Body weight (kg) will be assessment at baseline and after 20 weeks of the intervention.
Time frame: 20 weeks
Body height
Body height (cm) will be assessment at baseline of the intervention.
Time frame: Baseline
Body composition
Fat mass (%), fat free mass (%) will be assessment at baseline and after 20 weeks of the intervention.
Time frame: 20 weeks
Blood lipid profile: cholesterole
Cholesterole (mg/dL) will be measured at baseline and after 20 weeks of the intervention
Time frame: 20 weeks
Blood lipid profile: triglicerydes
Triglicerydes (mg/dL) will be measured at baseline and after 20 weeks of the intervention
Time frame: 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
Time frame: 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
Time frame: 20 weeks
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
Time frame: 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
Time frame: 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
Time frame: 20 weeks
Ran from Apr 2018 to primary completion in Dec 2020, 32 months.
Of 714 non-industry interventional studies with no phase under Insulin Resistance, half reached primary completion within 22 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 41. This study's 32 months is above that.
Counting every sponsor, half of 754 studies reached it within 21 months; a quarter within 9 and three quarters within 40.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Apr 2022. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Bifidobacterium animalis subsp. lactis
Poznan University of Life Sciences