Menopause, hot flashes, urogenital atrophy
Conditions
Interventions
Each of the three treatment groups consists of 20 participants to be followed over 16 weeks. The participants have been randomized according to the following therapies:
- Soy isoflavone group (n=20):
- Soy isoflavones + probiotics group (n=20): ingestion of one capsule containing 60mg of isoflavone (SoyFemme®, Aché Pharmaceuticals) plus one pack of probiotic (SimFort - Vitafor Nutrientes). SimFort
Drug
Dietary supplement
E02.190.755
G07.203.300.456
Sponsors
Universidade Estadual de Campinas
Universidade Estadual de Campinas
Eligibility
Sex/Gender
Female
Age
40 Years to 60 Years
Inclusion criteria
Inclusion criteria: Women between 40 and 60 years of age; latest menstrual period has occurred at least 12 months previously; follicle-stimulating hormone (FSH) levels are higher than 40mIU/mL; estradiol levels are lower than 20 pg/ml;currently present symptoms of estrogen deprivation.
Exclusion criteria
Exclusion criteria: History of chronic conditions such as Type 2 diabetes mellitus; cardiovascular or gastro-intestinal disorders; contraindications to hormone replacement therapy; soy-intolerant; vegetarians; undergone bariatric surgery; undergone hysterectomy; undergone hormone replacement therapy; oral contraceptives; antibiotics or lipid-lowering drugs in the previous 6 months.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The effects of the use of phytoestrogens associated to probiotics on the relief of climacteric symptoms at the end of the treatment may be superior to those of the use of phytoestrogens in isolation and similar to the effects seen in users of HT. To that end, the intensity of climacteric symptoms will be evaluated in a period of four months through the use of MRS (Menopause Rating Scale) questionnaires. The MRS is composed of 11 items assessing menopausal symptoms and is divided into three subscales: somatic symptoms, psychological symptoms, and urogenital symptoms. Each item is graded by the participant, with scores ranging from 0 (absent) to 4 (1, mild; 2, moderate; 3, severe; 4, very severe). The urinary symptoms will be evaluated through the International Consultation on Incontinence Questionnaire – Short Form (ICIQ-SF). Vaginal tropism will be evaluated through the Vaginal Health Score Index, vaginal cytology, vaginal pH, and vaginal microbiota. The Vaginal Health Score Index is composed of 5 items (elasticity, fluid volume, pH, epithelial integrity, and moisture) graded from 1 to 5 and evaluated during gynecological examination. A score lower than 15 will indicate vaginal atrophy. The maturation index of vaginal cytology will be evaluated and vaginal pH will be measured using pH paper in contact with the vaginal epithelium. Vaginal microbiota will be evaluated through Gram staining and classified into: type 1 (85% or more of Lactobacillus), type 2 (the same proportion of Lactobacillus and coccoid microbiota), and type 3 (nearly complete absence of Lactobacillus with the presence of coccoid microbiota). | — |
Secondary
| Measure | Time frame |
|---|---|
| The women who use isoflavone associated to probiotics will produce (S)-equol, (R)-equol, and O-DMA. The measurement of equol and O-DMA will be performed through urine by stable-isotope dilution mass spectrometry. The subjects will be classified as equol-producing when blood concentrations are 83 nmol/L. When O-DMA is detected by the test, the subject will be classified as O-DMA-producing. ;The equol-producing women will have benefits to their metabolic profiles which the non-equol-producing women will not. Equol production may be maximized through the administration of probiotics. To that end, blood glucose and lipid profiles will be measured after 12-hour fasting. Blood glucose will be classified as normal if between 70 mg/dL and 110 mg/dL, and as high if above 110 mg/dL. Total cholesterol will be classified as normal if below 240 mg/dl, and as high if 240 mg/dl or above. LDL-C: normal if below 160 mg/dL, and high if 160 mg/dL or above. HDL-C: normal if 40 mg/dL or above, and low if below 40 mg/dL. Triglycerides: normal if below 200 mg/dL, and high if 200 mg/dL or above.;The equol-producing women will have a wider diversity of strains in their intestinal microbiota than non-equol producing women. The analysis of the intestinal microbiota will be performed through stool analysis in order to identify the predominant phyla present in the microbiota of equol-producing individuals. | — |
Countries
Brazil
Contacts
Public ContactAdriana;Gabriela Pedro Campana;Alves Macedo
Universidade Estadual de Campinas;Universidade Estadual de Campinas
Outcome results
None listed