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NCT05019859 Clinical Trial

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

Metabolic Syndrome Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05019859
Other study ID # HMoinhosVento
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date October 1, 2017
Est. completion date December 1, 2021

Study information
Verified date July 2021
Source Hospital Moinhos de Vento
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility
Status Completed
Enrollment 24
Est. completion date December 1, 2021
Est. primary completion date August 1, 2021
Accepts healthy volunteers No
Gender Male
Age group 18 Years and older
Eligibility Inclusion Criteria: - metabolic syndrome, serum testosterone level below 300 ng/dL Exclusion Criteria: - active cancer, diet allergies, psychological incapability

Study Design

Related Conditions & MeSH terms

Intervention

Behavioral:
• low carb diet
low carb diet

Locations
Country Name City State
Brazil Hospital de Clínicas Porto Alegre Porto Alegre RS

Sponsors (2)
Lead Sponsor Collaborator
Hospital Moinhos de Vento Hospital de Clinicas de Porto Alegre

Country where clinical trial is conducted

Brazil, 

Outcome
Type Measure Description Time frame Safety issue
Primary testosterone serum total testosterone level three months
Secondary IIEF 5 International Index of Erectile Function 5 three months
Secondary AMS Age male Symptom score three months
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