Weight Loss Impact on Male Fertility

Study Overview
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Brief Summary
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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.

Official Title
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Significative Weight Loss Impact on Oxidative Stress, Metabolic, Hormonal, Inflammatory and Seminal Parameters of Obese Men.

Conditions
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Obesity, Sub Fertility, Male, Metabolic Syndrome

Intervention / Treatment
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* Dietary Supplement: Very Low Carb Ketogenic Diet


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: Prospective, unicentre, single group
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Weight loss<br> | Dietary Supplement: Very Low Carb Ketogenic Diet<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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. | 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 |