NCT04186767

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable obesity

Timeline
Completed

Started Jan 2019

Longer than P75 for not_applicable obesity

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 10, 2019

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

April 21, 2019

Completed
8 months until next milestone

First Posted

Study publicly available on registry

December 5, 2019

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 20, 2020

Completed
2.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 22, 2023

Completed
Last Updated

February 28, 2023

Status Verified

February 1, 2023

Enrollment Period

1.6 years

First QC Date

April 21, 2019

Last Update Submit

February 26, 2023

Conditions

ObesitySub Fertility, MaleMetabolic Syndrome

Outcome Measures

Primary Outcomes (3)

  • Seminal evaluation

    Spermatic counting will be combined to report

    Six months

  • Seminal evaluation

    Spermatic motility will be combined to report

    Six months

  • Seminal evaluation

    DNA fragmentation will be combined to report

    Six months

Secondary Outcomes (9)

  • Metabolic response

    Six months

  • Hormonal measurements

    Six months

  • Inflamatory response

    Six months

  • Adipose tissue evaluation

    Six months

  • Microbiota evaluation

    Six months

  • +4 more secondary outcomes

Study Arms (1)

Weight loss

EXPERIMENTAL
Dietary Supplement: Very Low Carb Ketogenic Diet

Interventions

Very Low Carb Ketogenic DietDIETARY_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.

Weight loss

Eligibility Criteria

Age18 Years - 55 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Obesity in male patients
  • Metabolic Syndrome (NCEP-ATP III)
  • Alteration of some of the seminal parameters evaluated in conventional seminal analysis

You may not qualify if:

  • 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
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital das Clinicas da Faculdade de Medicina da USP

São Paulo, São Paulo, 05403000, Brazil

Location

MeSH Terms

Conditions

ObesityInfertility, MaleMetabolic Syndrome

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesInfertilityMale Urogenital DiseasesInsulin ResistanceHyperinsulinismGlucose Metabolism DisordersMetabolic Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: Prospective, unicentre, single group
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

April 21, 2019

First Posted

December 5, 2019

Study Start

January 10, 2019

Primary Completion

August 20, 2020

Study Completion

January 22, 2023

Last Updated

February 28, 2023

Record last verified: 2023-02

Locations

BR(1)