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

Not Applicable

Completed

• Conditions: Metabolic Syndrome; Diet Modification; Testosterone Deficiency
• Interventions: Behavioral: low carb diet

• Registration Number: NCT05019859
• Lead Sponsor: Hospital Moinhos de Vento

Brief Summary

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

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 Timeline

• Study Start: 2017-10-01
• Status Verified: 2021-07
• Primary Completion: 2021-08-01
• Study First Submitted: 2021-08-18
• Study First Submitted QC: 2021-08-18
• Study First Posted: 2021-08-25
• Study Completion: 2021-12-01
• Last Update Submitted: 2022-05-27
• Last Update Posted: 2022-06-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 24

Inclusion Criteria

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

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Exclusion Criteria

• active cancer, diet allergies, psychological incapability

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention	low carb diet	low carb diet

Primary Outcome Measures

Name	Time	Method
testosterone	three months	serum total testosterone level

Secondary Outcome Measures

Name	Time	Method
IIEF 5	three months	International Index of Erectile Function 5
AMS	three months	Age male Symptom score

Trial Locations

Locations (1)

Hospital de Clínicas Porto Alegre; 🇧🇷 Porto Alegre, RS, Brazil