Weight Loss Impact on Male Fertility

Not Applicable

Completed

• Conditions: Metabolic Syndrome; Obesity; Sub Fertility, Male
• Interventions: Dietary Supplement: Very Low Carb Ketogenic Diet

• Registration Number: NCT04186767
• Lead Sponsor: University of Sao Paulo

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-01-10
• Study First Submitted: 2019-04-21
• Study First Submitted QC: 2019-12-02
• Study First Posted: 2019-12-05
• Primary Completion: 2020-08-20
• Study Completion: 2023-01-22
• Status Verified: 2023-02
• Last Update Submitted: 2023-02-26
• Last Update Posted: 2023-02-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 20

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Weight loss	Very Low Carb Ketogenic Diet	-

Primary Outcome Measures

Name	Time	Method
Seminal evaluation	Six months	DNA fragmentation will be combined to report

Secondary Outcome Measures

Name	Time	Method
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)
Microbiota evaluation	Six months	Evaluate the whole intestinal metagenomics before and after the intervention
Body composition changes	Six months	Apply body composition digital analyser pre and post intervention.
Metabolic response	Six months	To evaluate the metabolic parameters lipid and glycemic profiles before and after intervention.
Inflamatory response	Six months	To evaluate cytokines TNFa and IL-6 response before and after intervention.
Epigenetic evaluation	Six months	To evaluate the epigenetic methylation profile of spermatozoa before and after the intervention
Hormonal measurements	Six months	To evaluate hormonal parameters total testosterone, LH, FSH, insulin 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.

Trial Locations

Locations (1)

Hospital das Clinicas da Faculdade de Medicina da USP; 🇧🇷 São Paulo, Sao Paulo, Brazil