Insulin ResistanceProjectPCOSNCT03902301
Lactobacillus Rhamnosus and PCOS Treatment
A study testing Lactobacillus group and Dietary group in people with Insulin Resistance and Polycystic Ovary Syndrome, run by Poznan University of Life Sciences at 1 site in Poland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Insulin Resistance, Polycystic Ovary Syndrome, Hyperandrogenism
- What is being tested?
- Lactobacillus group and Dietary group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 sitePoland
- Study dates
- 1 Apr 2018to 31 Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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:
Show all 13Show fewer
- 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.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
- Being tested
- Lactobacillus group, Dietary group
- Keywords
- Lactobacillus rhamnosus, Polycystic Ovary Syndrome, insulin resistance, nutrition intervention, probiotic
- Medical subject headings
- Insulin Resistance, Polycystic Ovary Syndrome, Hyperandrogenism, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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).
Dietary groupDietary supplement
Nutritional intervention focused on the treatment of insulin resistance (35 subjects).
| Study group | Role | What they receive |
|---|---|---|
| Dietary group | Active comparator | A diet based on general recommendations for people with insulin resistance for 20 weeks. Receives: 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. Receives: Dietary Supplement: Lactobacillus group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 20 weeks
Free androgen index FAI
Results of testosterone level and SHBG level will be combined to report FAI index (index of free androgen).
Measured: 20 weeks
Body weight
Body weight (kg) will be assessment at baseline and after 20 weeks of the intervention.
Measured: 20 weeks
Body height
Body height (cm) will be assessment at baseline of the intervention.
Measured: Baseline
Body composition
Fat mass (%), fat free mass (%) will be assessment at baseline and after 20 weeks of the intervention.
Measured: 20 weeks
Blood lipid profile: cholesterole
Cholesterole (mg/dL) will be measured at baseline and after 20 weeks of the intervention
Measured: 20 weeks
Blood lipid profile: triglicerydes
Triglicerydes (mg/dL) will be measured at baseline and after 20 weeks of the intervention
Measured: 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
Measured: 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
Measured: 20 weeks
Secondary outcomes (3)
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
Measured: 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
Measured: 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
Measured: 20 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2019
- Study start1 Apr 2018
- Primary completion31 Dec 2020
- Study completion31 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Insulin ResistanceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Poznan University of Life Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Karolina Łagowska, Poznan University of Life Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03902301
- Sponsor's protocol ID
- Project PCOS
- Acronym
- ProjectPCOS
- Status last verified
- Apr 2022
- First submitted
- 11 Mar 2019
- Last updated
- 26 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03902301
- Acronym / sponsor ID
- ProjectPCOS / Project PCOS
- Keywords
- Lactobacillus rhamnosus, Polycystic Ovary Syndrome, insulin resistance, nutrition intervention, probiotic
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Poznan University of Life SciencesUniversity, hospital or other
- Study start
- 1 Apr 2018 (actual)
- Primary completion
- 31 Dec 2020 (actual)
- Study completion
- 31 Dec 2020 (actual)
- First posted
- 4 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dietary group | Active comparator | Dietary Supplement: Dietary groupA diet based on general recommendations for people with insulin resistance for 20 weeks. |
| Lactobacillus rhamnosus group | Experimental | Dietary Supplement: Lactobacillus groupLactobacillus rhamnosus for 20 weeks, (2x 6×10 9 CFU/per capsulex); A diet based on general recommendations for people with insulin resistance. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (13 listed)
- 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.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lactobacillus groupNutrition intervention focused on the treatment of insulin resistance + Lactobacillus rhamnosus supplementation (6x10 9 of lactobacillus rhamnosus x 2 times a day) (35 people). | Dietary supplement | Lactobacillus rhamnosus group |
| Dietary groupNutritional intervention focused on the treatment of insulin resistance (35 subjects). | Dietary supplement | Dietary group |
Primary outcome
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.
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).
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).
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).
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).
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).
Body weight
Time frame: 20 weeks
Body weight (kg) will be assessment at baseline and after 20 weeks of the intervention.
Body height
Time frame: Baseline
Body height (cm) will be assessment at baseline of the intervention.
Body composition
Time frame: 20 weeks
Fat mass (%), fat free mass (%) will be assessment at baseline and after 20 weeks of the intervention.
Blood lipid profile: cholesterole
Time frame: 20 weeks
Cholesterole (mg/dL) will be measured at baseline and after 20 weeks of the intervention
Blood lipid profile: triglicerydes
Time frame: 20 weeks
Triglicerydes (mg/dL) will be measured at baseline and after 20 weeks of the intervention
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
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
3 secondary outcomes
Assessment of qualitative and quantitative of the microbiome
Time frame: 20 weeks
Assessment of B-glucuronidase and B-glucosiadase activity
Time frame: 20 weeks
Assessment of short-chain fatty acids
Time frame: 20 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lactobacillus group and Dietary group in people with Insulin Resistance and Polycystic Ovary Syndrome, run by Poznan University of Life Sciences at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Insulin Resistance (time frame: 20 weeks). The study lists 13 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Apr 2022.