This is a prospective non-randomized unicentric clinical trial, characterized by the inclusion of obese (BMI\> 35) male with subfertility (sperm count showing low sperm counts and / or motility and / or morphology and / or DNA fragmentation). Patients selected at the endocrinology obesity HC-FMUSP outpatient will be submitted to very low calorie diet (VLCK) for 6 months, being reassessed clinically and laboratorially monthly.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
20
Patients will be submitted to very low-calorie ketogenic dietary intervention (VLCK) according to the recommendations of the Pronokal® Method program including lifestyle and physical activity guidelines. The ketogenic stage (phase 1-3) consists of a VLCD diet (600-800 kcal / d), with low carbohydrate intake and lipids. The amount of high biological value proteins ranges from 0.8 to 1.2 g / kg of body weight / day. This first stage (ketogenic) is maintained until the patient reaches the goal of reducing the target weight by 80% to be reduced, being variable in time, according to the response of each patient. After this period, it evolved to a non-ketogenic stage, initiating the hypocaloric diet (800 to 1500 Kcal), with progressive introduction of other food groups, reducing weight more slowly. The maintenance stage consists of a balanced diet, ranging from 1500 to 2000 Kcal.
Hospital das Clinicas da Faculdade de Medicina da USP
São Paulo, São Paulo, Brazil
Seminal evaluation
Spermatic counting will be combined to report
Time frame: Six months
Seminal evaluation
Spermatic motility will be combined to report
Time frame: Six months
Seminal evaluation
DNA fragmentation will be combined to report
Time frame: Six months
Metabolic response
To evaluate the metabolic parameters lipid and glycemic profiles before and after intervention.
Time frame: Six months
Hormonal measurements
To evaluate hormonal parameters total testosterone, LH, FSH, insulin before and after intervention.
Time frame: Six months
Inflamatory response
To evaluate cytokines TNFa and IL-6 response before and after intervention.
Time frame: Six months
Adipose tissue evaluation
To evaluate adipokines: leptin, adiponectin, UCP-1, FGF21, irisin and PGC1a measures before and after intervention.
Time frame: Six months
Microbiota evaluation
Evaluate the whole intestinal metagenomics before and after the intervention
Time frame: Six months
Epigenetic evaluation
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To evaluate the epigenetic methylation profile of spermatozoa before and after the intervention
Time frame: Six months
Body composition changes
Apply body composition digital analyser pre and post intervention.
Time frame: Six months
Brow tissue study
Thermodynamic evaluation of brown adipose tissue using infrared thermography.
Time frame: Six months
Adipose tissue toxins study
Persistent organic pollutants measure: 2,3,7,8- tetrachlorodibenzo-p-dioxin (TCDD)
Time frame: Six months