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Lactobacillus Rhamnosus and PCOS Treatment (ProjectPCOS)

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ClinicalTrials.gov Identifier: NCT03902301
Recruitment Status : Recruiting
First Posted : April 4, 2019
Last Update Posted : April 4, 2019
Sponsor:
Information provided by (Responsible Party):
Karolina Łagowska, Poznan University of Life Sciences

Study Description
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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.

Condition or disease Intervention/treatment Phase
Insulin Resistance Polycystic Ovary Syndrome Hyperandrogenism Obesity Dietary Supplement: Lactobacillus group Dietary Supplement: Dietary group Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
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
Actual Study Start Date : February 1, 2019
Estimated Primary Completion Date : December 30, 2020
Estimated Study Completion Date : June 30, 2021

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Dietary group
A diet based on general recommendations for people with insulin resistance for 20 weeks.
 Dietary Supplement: Dietary group
Nutritional intervention focused on the treatment of insulin resistance (35 subjects).
Experimental: 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.
 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).


Outcome Measures
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Primary Outcome Measures :
  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.


Secondary Outcome Measures :
  1. Blood lipid profile: cholesterole [ Time Frame: 20 weeks ]
    Cholesterole (mg/dL) will be measured at baseline and after 20 weeks of the intervention

  2. Blood lipid profile: triglicerydes [ Time Frame: 20 weeks ]
    Triglicerydes (mg/dL) will be measured at baseline and after 20 weeks of the intervention

  3. 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

  4. 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

  5. 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


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03902301


Locations
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Poland
Poznan University of Life Sciences Recruiting
Poznan, Poland, 60-624
Contact: Karolina Łagowska, PhD    +48618487335    karolina.lagowska@up.poznan.pl   
Sponsors and Collaborators
Poznan University of Life Sciences
More Information
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Responsible Party: Karolina Łagowska, Principal Investigator (dr inż), Poznan University of Life Sciences
ClinicalTrials.gov Identifier: NCT03902301    
Other Study ID Numbers: Project PCOS
First Posted: April 4, 2019    Key Record Dates
Last Update Posted: April 4, 2019
Last Verified: April 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Karolina Łagowska, Poznan University of Life Sciences:
Lactobacillus rhamnosus
Polycystic Ovary Syndrome
insulin resistance
nutrition intervention
probiotic
Additional relevant MeSH terms:
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Polycystic Ovary Syndrome
Hyperandrogenism
Insulin Resistance
Syndrome
Disease
Pathologic Processes
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Ovarian Cysts
Cysts
 Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Gonadal Disorders
Endocrine System Diseases
46, XX Disorders of Sex Development
Disorders of Sex Development
Urogenital Abnormalities
Adrenogenital Syndrome
Congenital Abnormalities