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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Weight loss | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Very Low Carb Ketogenic Diet | Dietary Supplement | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Seminal evaluation | Spermatic counting will be combined to report | Six months |
| Seminal evaluation | Spermatic motility will be combined to report | Six months |
| Seminal evaluation | DNA fragmentation will be combined to report | Six months |
| Measure | Description | Time Frame |
|---|---|---|
| Metabolic response | To evaluate the metabolic parameters lipid and glycemic profiles before and after intervention. | Six months |
| Hormonal measurements | To evaluate hormonal parameters total testosterone, LH, FSH, insulin before and after intervention. |
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Inclusion Criteria:
Obesity in male patients
Exclusion Criteria:
Other causes of hypogonadotrophic hypogonadism
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital das Clinicas da Faculdade de Medicina da USP | São Paulo | São Paulo | 05403000 | Brazil |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| D007248 | Infertility, Male |
| D024821 | Metabolic Syndrome |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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Prospective, unicentre, single group
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|
| Six months |
| Inflamatory response | To evaluate cytokines TNFa and IL-6 response before and after intervention. | Six months |
| Adipose tissue evaluation | To evaluate adipokines: leptin, adiponectin, UCP-1, FGF21, irisin and PGC1a measures before and after intervention. | Six months |
| Microbiota evaluation | Evaluate the whole intestinal metagenomics before and after the intervention | Six months |
| Epigenetic evaluation | To evaluate the epigenetic methylation profile of spermatozoa before and after the intervention | Six months |
| Body composition changes | Apply body composition digital analyser pre and post intervention. | Six months |
| Brow tissue study | Thermodynamic evaluation of brown adipose tissue using infrared thermography. | Six months |
| Adipose tissue toxins study | Persistent organic pollutants measure: 2,3,7,8- tetrachlorodibenzo-p-dioxin (TCDD) | Six months |
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007246 | Infertility |
| D052801 | Male Urogenital Diseases |
| D007333 | Insulin Resistance |
| D006946 | Hyperinsulinism |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |