Effects of a Low Carb Diet on Erectile Function and Serem Testosterone in Men With Metabolic Syndrome

May 27, 2022 updated by: Hospital Moinhos de Vento
Investigate if low carb diet could increase serum testosterone level in hypogonadic men

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Randomized controlled trial to evaluate the effect of low carb diet in men with metabolic syndrome and low testosterone level. The inclusion criteria is men with metabolic syndrome and serum total testosterone below 300 ng/dL. They will randomized to perform a low carb diet or a traditional low fat diet for metabolic syndrome. The follow up will be of three months with a once a month visit. Even though these men will be looked at their sexuality and life style. They will be monitoring by urologists and nutritionists during the study.

Study Type

Interventional

Enrollment (Actual)

24

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • RS
      • Porto Alegre, RS, Brazil, 90035-903
        • Hospital de Clínicas Porto Alegre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • metabolic syndrome, serum testosterone level below 300 ng/dL

Exclusion Criteria:

  • active cancer, diet allergies, psychological incapability

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Intervention
low carb diet
Behavioral: low carb diet
low carb diet
NO_INTERVENTION: Control
traditional low fat diet

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
testosterone
Time Frame: three months
serum total testosterone level
three months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
IIEF 5
Time Frame: three months
International Index of Erectile Function 5
three months
AMS
Time Frame: three months
Age male Symptom score
three months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital Moinhos de Vento

Collaborators

Hospital de Clinicas de Porto Alegre

Investigators

  • Study Chair: Brasil S Neto, MD, PhD, Hospital de Clínicas Porto Alegre
  • Principal Investigator: Caio S Schmitt, MD, Hospital Moinhos de Vento and Hospital de Clínicas Porto Alegre

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

October 1, 2017

Primary Completion (ACTUAL)

August 1, 2021

Study Completion (ACTUAL)

December 1, 2021

Study Registration Dates

First Submitted

August 18, 2021

First Submitted That Met QC Criteria

August 18, 2021

First Posted (ACTUAL)

August 25, 2021

Study Record Updates

Last Update Posted (ACTUAL)

June 2, 2022

Last Update Submitted That Met QC Criteria

May 27, 2022

Last Verified

July 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HMoinhosVento

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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