Insulin Resistance, Polycystic Ovarian Syndrome
Conditions
Keywords
Polycystic ovarian syndrome, Extract plant, Probiotics, Insulin resistance
Brief summary
The aim of the present study is to evaluate the effect of the combination of a plant extract (BSL\_EP044) and Lactobacillus BSL\_PS6 on parameters of the glucidic metabolism, anthropometric parameters, hormonal levels and the menstrual cycle in women with polycystic ovary syndrome and high insulin levels.
Detailed description
Polycystic ovary syndrome (PCOS) is the most prevalent endocrinopathy in women, affecting 4-15% of those who are of childbearing age. It is a complex and heterogeneous disease in which the gynecological disorder coexist with metabolic problems such as insulin resistance. The beneficial effect of the extract plant BSL-EP044 on glycemic metabolism in women with PCOS is widely studied and demonstrated and Lactobacillus BSL\_PS6 appears to exert a synergistic effect by supplementing the effect of BSL-EP044. The hypothesis of our study is that the addition of the probiotic strain Lactobacillus BSL\_PS6 to extract plant BSL-EP044 treatment may improve the beneficial effect of this one on insulin resistance and other metabolic alterations related to PCOS. The main objective of the present study is to evaluate the effect of the combination of a Plant Extract (BSL\_EP044) and Lactobacillus BSL\_PS6 on parameters related to glycemic metabolism in women with polycystic ovary syndrome and high insulin levels.
Interventions
COMBINATION_PRODUCTCombination of a plant extract (BSL_EP044) and Lactobacillus BSL_PS6
Each participant will consume 2 capsules daily, in the morning and at night without any restriction in the diet nor in their habits of life.
COMBINATION_PRODUCTPlacebo
Each participant will consume 2 capsules daily, in the morning and at night without any restriction in the diet nor in their habits of life.
Sponsors
Biosearch S.A.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Being diagnosed with polycystic ovarian syndrome according to the Rotterdam criteria. * HOMA values between 2.5 and 3. * Body mass index of less than 35 kg/m2. * Accept freely to participate in the study and sign the informed consent document.
Exclusion criteria
* Women in treatment with oral antidiabetics. * Being pregnant or intending to get pregnant. * Be in fertility treatment. * To suffer from other diseases that affect the hormonal response or that could interfere with the glucidic metabolism.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Plasma insulin | 12 weeks | Levels of plasma insulin |
| HOMA | 12 weeks | Insulin sensitivity |
| Plasma glucose | 12 weeks | Levels of plasma glucose |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Total testosterone | 12 weeks | Total testosterone |
| Free testosterone | 12 weeks | Free testosterone |
Other
| Measure | Time frame | Description |
|---|---|---|
| BMI | 12 weeks | Body mass index |
| Ovarian cycle | 12 weeks | Duration of the ovarian cycle |
| Blood pressure | 12 weeks | Systolic and diastolic pressure during the study |
| Weight | 12 weeks | Weight variation throughout the study |
Countries
Spain
Contacts
Primary ContactJuristo Fonollá, PhD
Outcome results
None listed