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Weight Loss Impact on Male Fertility

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04186767
Recruitment Status : Recruiting
First Posted : December 5, 2019
Last Update Posted : December 5, 2019
Sponsor:
Information provided by (Responsible Party):
Alessandra Renck, 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.

Condition or disease Intervention/treatment Phase
Obesity Sub Fertility, Male Metabolic Syndrome Dietary Supplement: Very Low Carb Ketogenic Diet Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Intervention Model: Single Group Assignment
Intervention Model Description: Prospective, unicentre, single group
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Significative Weight Loss Impact on Oxidative Stress, Metabolic, Hormonal, Inflammatory and Seminal Parameters of Obese Men.
Actual Study Start Date : January 10, 2019
Estimated Primary Completion Date : January 2020
Estimated Study Completion Date : January 2020

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  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 Outcome Measures :
  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)



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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04186767


Contacts
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Contact: Alessandra C Renck, MD +5511981211114 alerenck@usp.br

Locations
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Brazil
Hospital das Clinicas da Faculdade de Medicina da USP Recruiting
São Paulo, Sao Paulo, Brazil, 05403000
Contact: Alessandra C Renck, MD    +5511981211114    alerenck@usp.br   
Sponsors and Collaborators
University of Sao Paulo

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Responsible Party: Alessandra Renck, Principal Investigator, University of Sao Paulo
ClinicalTrials.gov Identifier: NCT04186767    
Other Study ID Numbers: 86158918.4.0000.0068
First Posted: December 5, 2019    Key Record Dates
Last Update Posted: December 5, 2019
Last Verified: December 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Infertility
Infertility, Male
Metabolic Syndrome
Weight Loss
Body Weight Changes
Body Weight
Signs and Symptoms
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Genital Diseases, Male
Genital Diseases, Female