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OpenTrials
Completed

NCT Number: NCT05019859

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

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

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Key information

Conditions

Testosterone Deficiency Diet Modification Endocrine System Diseases Glucose Metabolism Disorders Gonadal Disorders Hyperinsulinism Hypogonadism Insulin Resistance Metabolic Diseases Metabolic Syndrome Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Hospital de Clínicas Porto Alegre

Porto Alegre, Rio Grande do Sul, 90035-903, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • active cancer, diet allergies, psychological incapability

Treatment and study plan

low carb diet

Behavioral

low carb diet

Primary outcomes

  1. testosterone

    Time frame: three months

    serum total testosterone level

Secondary outcomes

  1. IIEF 5

    Time frame: three months

    International Index of Erectile Function 5

  2. AMS

    Time frame: three months

    Age male Symptom score

Sponsors and collaborators

Lead sponsor

Hospital Moinhos de Vento

Other

Collaborators

  • Hospital de Clinicas de Porto Alegre

Registry information

Important dates

Study start
2017
Primary completion
2021
Study completion
2021
First posted
Aug 25, 2021
Registry last updated
Jun 2, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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