NCT05019859

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2017

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2021

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

August 18, 2021

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 25, 2021

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2021

Completed
Last Updated

June 2, 2022

Status Verified

July 1, 2021

Enrollment Period

3.8 years

First QC Date

August 18, 2021

Last Update Submit

May 27, 2022

Conditions

Testosterone DeficiencyMetabolic SyndromeDiet Modification

Keywords

low carb diethypogonadismmetabolic syndrome

Outcome Measures

Primary Outcomes (1)

  • testosterone

    serum total testosterone level

    three months

Secondary Outcomes (2)

  • IIEF 5

    three months

  • AMS

    three months

Study Arms (2)

Intervention

ACTIVE COMPARATOR

low carb diet

Behavioral: low carb diet

Control

NO INTERVENTION

traditional low fat diet

Interventions

low carb dietBEHAVIORAL

low carb diet

Intervention

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • active cancer, diet allergies, psychological incapability

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital de Clínicas Porto Alegre

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

Location

MeSH Terms

Conditions

Metabolic SyndromeHypogonadism

Condition Hierarchy (Ancestors)

Insulin ResistanceHyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesGonadal DisordersEndocrine System Diseases

Study Officials

  • 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

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Randomized Controlled Trial
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 18, 2021

First Posted

August 25, 2021

Study Start

October 1, 2017

Primary Completion

August 1, 2021

Study Completion

December 1, 2021

Last Updated

June 2, 2022

Record last verified: 2021-07

Locations

BR(1)