Inositol, Testosterone, Insulin, Ovulation, Asprosin
Conditions
Brief summary
Healthy women will take tablets containing 600 mg D-chiro-inositol twice per day for one month. We will evaluate metabolic and hormonal.parameters, as insulienmia, glycemia, estradiol, testosterone.
Interventions
DIETARY_SUPPLEMENTD-chiro-inositol
D-chiro-inositol 600 mg twice per day on an empty stomach for one month
Sponsors
Lo.Li.Pharma s.r.l
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Intervention model description
Human healthy women
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 50 Years
Healthy volunteers
Yes
Inclusion criteria
* Good state of health; * Regular menstrual cycle.
Exclusion criteria
* pregnancy; * delivery in the previous 6 months; * currently breastfeeding; * menopause; * alcohol or drug abuse; * insulin resistance defined as HOMA-IR index greater than or equal to 2.5; * other medical morbidities, such as hypertension, PCOS, or diabetes; * oligomenorrhea or amenorrhea; * current treatment with corticosteroids or hormones (oral contraceptives, estrogensic, progestogensin); * use of GnRH analogues, SERMs, or SPRMs within the previous 6 months.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Testosterone | 30 days | Serum values of testosterone |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Glycemia | 30 days | Serum values of glucose |
| Insulinemia | 30 days | Serum values of insulin |
| HOMA-IR index | 30 days | Model of assessment for insulin resistance |
| FSH | 30 days | Serum values of FSH |
| BMI | 30 days | body-mass index |
| Estradiol | 30 days | Serum values of estradiol |
| DHEAS | 30 days | Serum values of DHEAS |
| Asprosin | 30 days | Serum values of asprosin |
| LH | 30 days | Serum values of LH |
Countries
Italy
Outcome results
None listed