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OpenTrials
Completed

NCT Number: NCT04186767

Weight Loss Impact on Male Fertility

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.

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Key information

Conditions

Obesity Body Weight Genital Diseases Genital Diseases, Male Glucose Metabolism Disorders Hyperinsulinism Infertility Infertility, Male Insulin Resistance Male Urogenital Diseases Metabolic Diseases Metabolic Syndrome Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms Sub Fertility, Male Urogenital Diseases

Age range

18 year–55 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Hospital das Clinicas da Faculdade de Medicina da USP

São Paulo, 05403000, Brazil

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Very Low Carb Ketogenic Diet

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.

Primary outcomes

  1. Seminal evaluation

    Time frame: Six months

    Spermatic counting will be combined to report

  2. Seminal evaluation

    Time frame: Six months

    Spermatic motility will be combined to report

  3. Seminal evaluation

    Time frame: Six months

    DNA fragmentation will be combined to report

Secondary outcomes

  1. Metabolic response

    Time frame: Six months

    To evaluate the metabolic parameters lipid and glycemic profiles before and after intervention.

  2. Hormonal measurements

    Time frame: Six months

    To evaluate hormonal parameters total testosterone, LH, FSH, insulin before and after intervention.

  3. Inflamatory response

    Time frame: Six months

    To evaluate cytokines TNFa and IL-6 response before and after intervention.

  4. Adipose tissue evaluation

    Time frame: Six months

    To evaluate adipokines: leptin, adiponectin, UCP-1, FGF21, irisin and PGC1a measures before and after intervention.

  5. Microbiota evaluation

    Time frame: Six months

    Evaluate the whole intestinal metagenomics before and after the intervention

  6. Epigenetic evaluation

    Time frame: Six months

    To evaluate the epigenetic methylation profile of spermatozoa before and after the intervention

  7. Body composition changes

    Time frame: Six months

    Apply body composition digital analyser pre and post intervention.

  8. Brow tissue study

    Time frame: Six months

    Thermodynamic evaluation of brown adipose tissue using infrared thermography.

  9. Adipose tissue toxins study

    Time frame: Six months

    Persistent organic pollutants measure: 2,3,7,8- tetrachlorodibenzo-p-dioxin (TCDD)

Sponsors and collaborators

Lead sponsor

University of Sao Paulo

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2020
Study completion
2023
First posted
Dec 5, 2019
Registry last updated
Feb 28, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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