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Completed

NCT Number: NCT03902301

Lactobacillus Rhamnosus and PCOS 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.

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Key information

Conditions

Insulin Resistance 46, XX Disorders of Sex Development Adnexal Diseases Adrenogenital Syndrome Body Weight Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Cysts Disorders of Sex Development Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Glucose Metabolism Disorders Gonadal Disorders Hyperandrogenism Hyperinsulinism Male Urogenital Diseases Metabolic Diseases Neoplasms Nutrition Disorders Nutritional and Metabolic Diseases Obesity Ovarian Cysts Ovarian Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Polycystic Ovary Syndrome Signs and Symptoms Urogenital Abnormalities Urogenital Diseases

Age range

18 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Poznan University of Life Sciences

Poznan, 60-624, Poland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Lactobacillus group

Dietary Supplement

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

Dietary Supplement

Nutritional intervention focused on the treatment of insulin resistance (35 subjects).

Primary outcomes

  1. 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.

  2. 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).

  3. 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).

  4. 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).

  5. 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).

  6. 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).

  7. Body weight

    Time frame: 20 weeks

    Body weight (kg) will be assessment at baseline and after 20 weeks of the intervention.

  8. Body height

    Time frame: Baseline

    Body height (cm) will be assessment at baseline of the intervention.

  9. Body composition

    Time frame: 20 weeks

    Fat mass (%), fat free mass (%) will be assessment at baseline and after 20 weeks of the intervention.

  10. Blood lipid profile: cholesterole

    Time frame: 20 weeks

    Cholesterole (mg/dL) will be measured at baseline and after 20 weeks of the intervention

  11. Blood lipid profile: triglicerydes

    Time frame: 20 weeks

    Triglicerydes (mg/dL) will be measured at baseline and after 20 weeks of the intervention

  12. 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

  13. 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

Secondary outcomes

  1. Assessment of qualitative and quantitative of the microbiome

    Time frame: 20 weeks

    Qualitative and quantitative determination of the composition of gut microbiota will be assessment at baseline and after 20 weeks of the intervention

  2. Assessment of B-glucuronidase and B-glucosiadase activity

    Time frame: 20 weeks

    B-glucuronidase and B-glucosiadase activity in stoolen sample will be assessment at baseline and after 20 weeks of the intervention

  3. Assessment of short-chain fatty acids

    Time frame: 20 weeks

    Assessment of short-chain fatty acids will be assessment at baseline and after 20 weeks of the intervention

Sponsors and collaborators

Lead sponsor

Poznan University of Life Sciences

Other

Registry information

Official study 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

Acronym: ProjectPCOS

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Apr 4, 2019
Registry last updated
Apr 26, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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