Back to resultsEffects of a Low Carb Diet on Erectile Function and Serem Testosterone in Men With Metabolic Syndrome
Primary Purpose
Testosterone Deficiency, Metabolic Syndrome, Diet Modification
Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
low carb diet
Sponsored by
About this trial
This is an interventional treatment trial for Testosterone Deficiency focused on measuring low carb diet, hypogonadism, metabolic syndrome
Eligibility Criteria
Inclusion Criteria:
- metabolic syndrome, serum testosterone level below 300 ng/dL
Exclusion Criteria:
- active cancer, diet allergies, psychological incapability
Sites / Locations
- Hospital de Clínicas Porto Alegre
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
No Intervention
Arm Label
Intervention
Control
Arm Description
low carb diet
traditional low fat diet
Outcomes
Primary Outcome Measures
testosterone
serum total testosterone level
Secondary Outcome Measures
IIEF 5
International Index of Erectile Function 5
AMS
Age male Symptom score
Full Information
NCT ID
NCT05019859
First Posted
August 18, 2021
Last Updated
May 27, 2022
Sponsor
Hospital Moinhos de Vento
Collaborators
Hospital de Clinicas de Porto Alegre
1. Study Identification
Unique Protocol Identification Number
NCT05019859
Brief Title
Effects of a Low Carb Diet on Erectile Function and Serem Testosterone in Men With Metabolic Syndrome
Official Title
Effects of a Low Carb Diet on Erectile Function and Serem Testosterone in Men With Metabolic Syndrome
Study Type
Interventional
2. Study Status
Record Verification Date
July 2021
Overall Recruitment Status
Completed
Study Start Date
October 1, 2017 (Actual)
Primary Completion Date
August 1, 2021 (Actual)
Study Completion Date
December 1, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospital Moinhos de Vento
Collaborators
Hospital de Clinicas de Porto Alegre
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Testosterone Deficiency, Metabolic Syndrome, Diet Modification
Keywords
low carb diet, hypogonadism, metabolic syndrome
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized Controlled Trial
Masking
None (Open Label)
Allocation
Randomized
Enrollment
24 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intervention
Arm Type
Active Comparator
Arm Description
low carb diet
Arm Title
Control
Arm Type
No Intervention
Arm Description
traditional low fat diet
Intervention Type
Behavioral
Intervention Name(s)
low carb diet
Intervention Description
low carb diet
Primary Outcome Measure Information:
Title
testosterone
Description
serum total testosterone level
Time Frame
three months
Secondary Outcome Measure Information:
Title
IIEF 5
Description
International Index of Erectile Function 5
Time Frame
three months
Title
AMS
Description
Age male Symptom score
Time Frame
three months
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
metabolic syndrome, serum testosterone level below 300 ng/dL
Exclusion Criteria:
active cancer, diet allergies, psychological incapability
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Brasil S Neto, MD, PhD
Organizational Affiliation
Hospital de Clínicas Porto Alegre
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Caio S Schmitt, MD
Organizational Affiliation
Hospital Moinhos de Vento and Hospital de Clínicas Porto Alegre
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital de Clínicas Porto Alegre
City
Porto Alegre
State/Province
RS
ZIP/Postal Code
90035-903
Country
Brazil
12. IPD Sharing Statement
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Effects of a Low Carb Diet on Erectile Function and Serem Testosterone in Men With Metabolic Syndrome
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