Weight Loss Impact on Male Fertility

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

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 Overview

• Status: Completed
• Conditions: Obesity; Metabolic Syndrome; Sub Fertility, Male
• Intervention / Treatment: Dietary supplement: Very Low Carb Ketogenic Diet

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • Sao Paulo
    • São Paulo, Sao Paulo, Brazil, 05403000
      • Hospital das Clinicas da Faculdade de Medicina da USP

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Weight loss

Dietary supplement: 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Sao Paulo

Study record dates

Study Major Dates

• Study Start (Actual): January 10, 2019
• Primary Completion (Actual): August 20, 2020
• Study Completion (Actual): January 22, 2023

Study Registration Dates

• First Submitted: April 21, 2019
• First Submitted That Met QC Criteria: December 2, 2019
• First Posted (Actual): December 5, 2019

Study Record Updates

• Last Update Posted (Estimate): February 28, 2023
• Last Update Submitted That Met QC Criteria: February 26, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Body Weight; Insulin Resistance; Hyperinsulinism; Body Weight Changes; Infertility; Metabolic Syndrome; Weight Loss; Infertility, Male
• Other Study ID Numbers: 86158918.4.0000.0068

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No