Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
80 participants
INTERVENTIONAL
2018-04-01
2020-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Dietary group
A diet based on general recommendations for people with insulin resistance for 20 weeks.
Dietary group
Nutritional intervention focused on the treatment of insulin resistance (35 subjects).
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.
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).
Interventions
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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).
Eligibility Criteria
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Inclusion Criteria
* 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.
18 Years
40 Years
FEMALE
No
Sponsors
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Poznan University of Life Sciences
OTHER
Responsible Party
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Karolina Łagowska
Principal Investigator (dr inż)
Locations
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Poznan University of Life Sciences
Poznan, , Poland
Countries
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Other Identifiers
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Project PCOS
Identifier Type: -
Identifier Source: org_study_id
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