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

NCT ID: NCT05019859

Last Updated: 2022-06-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-10-01

Study Completion Date

2021-12-01

Brief Summary

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Investigate if low carb diet could increase serum testosterone level in hypogonadic men

Detailed Description

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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.

Conditions

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Testosterone Deficiency Metabolic Syndrome Diet Modification

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized Controlled Trial
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Intervention

low carb diet

Group Type ACTIVE_COMPARATOR

low carb diet

Intervention Type BEHAVIORAL

low carb diet

Control

traditional low fat diet

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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low carb diet

low carb diet

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* active cancer, diet allergies, psychological incapability
Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Hospital de Clinicas de Porto Alegre

OTHER

Sponsor Role collaborator

Hospital Moinhos de Vento

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Brasil S Neto, MD, PhD

Role: STUDY_CHAIR

Hospital de Clínicas Porto Alegre

Caio S Schmitt, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital Moinhos de Vento and Hospital de Clínicas Porto Alegre

Locations

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Hospital de Clínicas Porto Alegre

Porto Alegre, Rio Grande do Sul, Brazil

Site Status

Countries

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Brazil

Other Identifiers

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HMoinhosVento

Identifier Type: -

Identifier Source: org_study_id

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