Weight Loss Impact on Male Fertility

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04186767
• Other study ID #: 86158918.4.0000.0068
• Status: Completed
• Phase: N/A
• Start date: January 10, 2019
• Est. completion date: January 22, 2023

Study information

• Verified date: February 2023
• Source: University of Sao Paulo
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: January 22, 2023
• Est. primary completion date: August 20, 2020
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Infertility
• Infertility, Male
• Metabolic Syndrome
• Obesity
• Sub Fertility, Male
• Weight Loss

Intervention

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.

Locations

Country	Name	City	State
Brazil	Hospital das Clinicas da Faculdade de Medicina da USP	São Paulo	Sao Paulo

Sponsors (1)

Lead Sponsor	Collaborator
University of Sao Paulo

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Seminal evaluation	Spermatic counting will be combined to report	Six months
Primary	Seminal evaluation	Spermatic motility will be combined to report	Six months
Primary	Seminal evaluation	DNA fragmentation will be combined to report	Six months
Secondary	Metabolic response	To evaluate the metabolic parameters lipid and glycemic profiles before and after intervention.	Six months
Secondary	Hormonal measurements	To evaluate hormonal parameters total testosterone, LH, FSH, insulin before and after intervention.	Six months
Secondary	Inflamatory response	To evaluate cytokines TNFa and IL-6 response before and after intervention.	Six months
Secondary	Adipose tissue evaluation	To evaluate adipokines: leptin, adiponectin, UCP-1, FGF21, irisin and PGC1a measures before and after intervention.	Six months
Secondary	Microbiota evaluation	Evaluate the whole intestinal metagenomics before and after the intervention	Six months
Secondary	Epigenetic evaluation	To evaluate the epigenetic methylation profile of spermatozoa before and after the intervention	Six months
Secondary	Body composition changes	Apply body composition digital analyser pre and post intervention.	Six months
Secondary	Brow tissue study	Thermodynamic evaluation of brown adipose tissue using infrared thermography.	Six months
Secondary	Adipose tissue toxins study	Persistent organic pollutants measure: 2,3,7,8- tetrachlorodibenzo-p-dioxin (TCDD)	Six months