Effects of a Low Carb Diet on Erectile Function and Serem... | NCT05019859

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

NCT05019859

Sponsor

Hospital Moinhos de Vento

Status

Completed

Last Update Posted

Jun 2, 2022Actual

Enrollment

24Actual

Phase

Not Applicable

Conditions

Testosterone Deficiency
Metabolic Syndrome
Diet Modification

Interventions

low carb diet

Countries

Brazil

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2021

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 1, 2017Actual

Primary Completion Date

Aug 1, 2021Actual

Completion Date

Dec 1, 2021Actual

First Submitted Date

Aug 18, 2021

First Submission Date that Met QC Criteria

Aug 18, 2021

First Posted Date

Aug 25, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 27, 2022

Last Update Posted Date

Jun 2, 2022Actual

Name	Class
Hospital de Clinicas de Porto Alegre	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

24Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Intervention	Active Comparator	low carb diet	Behavioral: low carb diet
Control	No Intervention	traditional low fat diet

Interventions

Name	Type	Description	Arm Group Labels	Other Names
low carb diet	Behavioral	low carb diet	Intervention

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
testosterone	serum total testosterone level	three months

Secondary Outcomes

Measure	Description	Time Frame
IIEF 5	International Index of Erectile Function 5	three months
AMS	Age male Symptom score	three months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

metabolic syndrome, serum testosterone level below 300 ng/dL

Exclusion Criteria:

active cancer, diet allergies, psychological incapability

Accepts Healthy Volunteers

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Brasil S Neto, MD, PhD	Hospital de Clínicas Porto Alegre	Study Chair
Caio S Schmitt, MD	Hospital Moinhos de Vento and Hospital de Clínicas Porto Alegre	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hospital de Clínicas Porto Alegre		Porto Alegre	Rio Grande do Sul	90035-903	Brazil

Condition Browse Module

MeSH Terms

ID	Term
D024821	Metabolic Syndrome
D007006	Hypogonadism

Ancestor Terms

ID	Term
D007333	Insulin Resistance
D006946	Hyperinsulinism
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided