NCT03902301

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2018

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2018

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

March 11, 2019

Completed
24 days until next milestone

First Posted

Study publicly available on registry

April 4, 2019

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2020

Completed
Last Updated

April 26, 2022

Status Verified

April 1, 2022

Enrollment Period

2.8 years

First QC Date

March 11, 2019

Last Update Submit

April 19, 2022

Conditions

Insulin ResistancePolycystic Ovary SyndromeHyperandrogenismObesity

Keywords

Lactobacillus rhamnosusPolycystic Ovary Syndromeinsulin resistancenutrition interventionprobiotic

Outcome Measures

Primary Outcomes (13)

  • 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.

    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).

    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).

    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).

    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).

    20 weeks

  • Free androgen index FAI

    Results of testosterone level and SHBG level will be combined to report FAI index (index of free androgen).

    20 weeks

  • Body weight

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

    20 weeks

  • Body height

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

    Baseline

  • Body composition

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

    20 weeks

  • Blood lipid profile: cholesterole

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

    20 weeks

  • Blood lipid profile: triglicerydes

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

    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

    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

    20 weeks

Secondary Outcomes (3)

  • Assessment of qualitative and quantitative of the microbiome

    20 weeks

  • Assessment of B-glucuronidase and B-glucosiadase activity

    20 weeks

  • Assessment of short-chain fatty acids

    20 weeks

Study Arms (2)

Dietary group

ACTIVE COMPARATOR

A diet based on general recommendations for people with insulin resistance for 20 weeks.

Dietary Supplement: Dietary group

Lactobacillus rhamnosus group

EXPERIMENTAL

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

Interventions

Lactobacillus groupDIETARY_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).

Lactobacillus rhamnosus group
Dietary groupDIETARY_SUPPLEMENT

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

Dietary group

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Poznan University of Life Sciences

Poznan, 60-624, Poland

Location

MeSH Terms

Conditions

Insulin ResistancePolycystic Ovary SyndromeHyperandrogenismObesity

Condition Hierarchy (Ancestors)

HyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesOvarian CystsCystsNeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesGonadal DisordersEndocrine System Diseases46, XX Disorders of Sex DevelopmentDisorders of Sex DevelopmentUrogenital AbnormalitiesAdrenogenital SyndromeMale Urogenital DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesOverweightOvernutritionNutrition DisordersBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator (dr inż)

Study Record Dates

First Submitted

March 11, 2019

First Posted

April 4, 2019

Study Start

April 1, 2018

Primary Completion

December 31, 2020

Study Completion

December 31, 2020

Last Updated

April 26, 2022

Record last verified: 2022-04

Locations

PL(1)