Weight Loss Impact on Male Fertility
Primary Purpose
Obesity, Sub Fertility, Male, Metabolic Syndrome
Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Very Low Carb Ketogenic Diet
Sponsored by
About this trial
This is an interventional treatment trial for Obesity
Eligibility 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.
Sites / Locations
- Hospital das Clinicas da Faculdade de Medicina da USP
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Weight loss
Arm Description
Outcomes
Primary Outcome Measures
Seminal evaluation
Spermatic counting will be combined to report
Seminal evaluation
Spermatic motility will be combined to report
Seminal evaluation
DNA fragmentation will be combined to report
Secondary Outcome Measures
Metabolic response
To evaluate the metabolic parameters lipid and glycemic profiles before and after intervention.
Hormonal measurements
To evaluate hormonal parameters total testosterone, LH, FSH, insulin before and after intervention.
Inflamatory response
To evaluate cytokines TNFa and IL-6 response before and after intervention.
Adipose tissue evaluation
To evaluate adipokines: leptin, adiponectin, UCP-1, FGF21, irisin and PGC1a measures before and after intervention.
Microbiota evaluation
Evaluate the whole intestinal metagenomics before and after the intervention
Epigenetic evaluation
To evaluate the epigenetic methylation profile of spermatozoa before and after the intervention
Body composition changes
Apply body composition digital analyser pre and post intervention.
Brow tissue study
Thermodynamic evaluation of brown adipose tissue using infrared thermography.
Adipose tissue toxins study
Persistent organic pollutants measure: 2,3,7,8- tetrachlorodibenzo-p-dioxin (TCDD)
Full Information
NCT ID
NCT04186767
First Posted
April 21, 2019
Last Updated
February 26, 2023
Sponsor
University of Sao Paulo
1. Study Identification
Unique Protocol Identification Number
NCT04186767
Brief Title
Weight Loss Impact on Male Fertility
Official Title
Significative Weight Loss Impact on Oxidative Stress, Metabolic, Hormonal, Inflammatory and Seminal Parameters of Obese Men.
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
January 10, 2019 (Actual)
Primary Completion Date
August 20, 2020 (Actual)
Study Completion Date
January 22, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Sao Paulo
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Sub Fertility, Male, Metabolic Syndrome
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Prospective, unicentre, single group
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Weight loss
Arm Type
Experimental
Intervention Type
Dietary Supplement
Intervention Name(s)
Very Low Carb Ketogenic Diet
Intervention Description
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 Measure Information:
Title
Seminal evaluation
Description
Spermatic counting will be combined to report
Time Frame
Six months
Title
Seminal evaluation
Description
Spermatic motility will be combined to report
Time Frame
Six months
Title
Seminal evaluation
Description
DNA fragmentation will be combined to report
Time Frame
Six months
Secondary Outcome Measure Information:
Title
Metabolic response
Description
To evaluate the metabolic parameters lipid and glycemic profiles before and after intervention.
Time Frame
Six months
Title
Hormonal measurements
Description
To evaluate hormonal parameters total testosterone, LH, FSH, insulin before and after intervention.
Time Frame
Six months
Title
Inflamatory response
Description
To evaluate cytokines TNFa and IL-6 response before and after intervention.
Time Frame
Six months
Title
Adipose tissue evaluation
Description
To evaluate adipokines: leptin, adiponectin, UCP-1, FGF21, irisin and PGC1a measures before and after intervention.
Time Frame
Six months
Title
Microbiota evaluation
Description
Evaluate the whole intestinal metagenomics before and after the intervention
Time Frame
Six months
Title
Epigenetic evaluation
Description
To evaluate the epigenetic methylation profile of spermatozoa before and after the intervention
Time Frame
Six months
Title
Body composition changes
Description
Apply body composition digital analyser pre and post intervention.
Time Frame
Six months
Title
Brow tissue study
Description
Thermodynamic evaluation of brown adipose tissue using infrared thermography.
Time Frame
Six months
Title
Adipose tissue toxins study
Description
Persistent organic pollutants measure: 2,3,7,8- tetrachlorodibenzo-p-dioxin (TCDD)
Time Frame
Six months
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Facility Information:
Facility Name
Hospital das Clinicas da Faculdade de Medicina da USP
City
São Paulo
State/Province
Sao Paulo
ZIP/Postal Code
05403000
Country
Brazil
12. IPD Sharing Statement
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Weight Loss Impact on Male Fertility
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