Weight Loss Impact on Male Fertility

NCT ID: NCT04186767

Last Updated: 2023-02-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-01-10
• Study Completion Date: 2023-01-22

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.

Conditions

Obesity; Sub Fertility, Male; Metabolic Syndrome

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Weight loss

Group Type: EXPERIMENTAL

Very Low Carb Ketogenic Diet

Intervention Type: 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.

Interventions

Very 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.

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

University of Sao Paulo

OTHER

Sponsor Role: lead

Responsible Party

Alessandra Renck

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Hospital das Clinicas da Faculdade de Medicina da USP

São Paulo, São Paulo, Brazil

Countries

Brazil

Other Identifiers

86158918.4.0000.0068

Identifier Type: -

Identifier Source: org_study_id