Metabolic Syndrome, Obesity, Sub Fertility, Male
Conditions
Brief summary
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.
Interventions
DIETARY_SUPPLEMENTVery Low Carb Ketogenic Diet
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.
Sponsors
University of Sao Paulo
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Prospective, unicentre, single group
Eligibility
Sex/Gender
MALE
Age
18 Years to 55 Years
Healthy volunteers
No
Inclusion criteria
Obesity in male patients * Metabolic Syndrome (NCEP-ATP III) * Alteration of some of the seminal parameters evaluated in conventional seminal analysis
Exclusion criteria
* Other causes of hypogonadotrophic hypogonadism * Hypergonadotrophic hypogonadism * Contraindications for performance of ketogenic diet: * Type 1 or type 2 diabetes mellitus in insulin use * Food drive * Alcoholism or drug addiction * Severe psychiatric illness * Use of coumarin anticoagulants * Hepatic insufficiency * Severe renal impairment * Hematologic diseases * Cancer in activity, * Cardiovascular or cerebrovascular diseases (arrhythmias, recent myocardial infarction, unstable angina, decompensated heart failure, recent stroke) * Gout * Renal or biliary lithiasis * Major depression or other serious psychiatric illness.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Seminal evaluation | Six months | Spermatic counting will be combined to report |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Hormonal measurements | Six months | To evaluate hormonal parameters total testosterone, LH, FSH, insulin before and after intervention. |
| Inflamatory response | Six months | To evaluate cytokines TNFa and IL-6 response before and after intervention. |
| Adipose tissue evaluation | Six months | To evaluate adipokines: leptin, adiponectin, UCP-1, FGF21, irisin and PGC1a measures before and after intervention. |
| Microbiota evaluation | Six months | Evaluate the whole intestinal metagenomics before and after the intervention |
| Metabolic response | Six months | To evaluate the metabolic parameters lipid and glycemic profiles before and after intervention. |
| Body composition changes | Six months | Apply body composition digital analyser pre and post intervention. |
| Brow tissue study | Six months | Thermodynamic evaluation of brown adipose tissue using infrared thermography. |
| Adipose tissue toxins study | Six months | Persistent organic pollutants measure: 2,3,7,8- tetrachlorodibenzo-p-dioxin (TCDD) |
| Epigenetic evaluation | Six months | To evaluate the epigenetic methylation profile of spermatozoa before and after the intervention |
Countries
Brazil
Outcome results
None listed