Testosterone DeficiencyNCT05019859
Effects of a Low Carb Diet on Erectile Function and Serem Testosterone in Men With Metabolic Syndrome
A study testing low carb diet in people with Testosterone Deficiency and Metabolic Syndrome, run by Hospital Moinhos de Vento at 1 site in Brazil.
Trial summary
Investigate if low carb diet could increase serum testosterone level in hypogonadic men Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Testosterone Deficiency, Metabolic Syndrome, Diet Modification
- What is being tested?
- low carb diet
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Oct 2017to 1 Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- metabolic syndrome, serum testosterone level below 300 ng/dL
Who cannot join
- active cancer, diet allergies, psychological incapability
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Hospital de Clínicas Porto Alegre
Porto Alegre, Rio Grande do Sul, 90035-903
About this study
Investigate if low carb diet could increase serum testosterone level in hypogonadic men
Read the 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.
- Being tested
- low carb diet
- Keywords
- low carb diet, hypogonadism, metabolic syndrome
- Medical subject headings
- Metabolic Syndrome, Hypogonadism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
low carb dietBehavioural
low carb diet
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Active comparator | low carb diet Receives: Behavioral: low carb diet |
| Control | No intervention | traditional low fat diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
testosterone
serum total testosterone level
Measured: three months
Secondary outcomes (2)
IIEF 5
International Index of Erectile Function 5
Measured: three months
AMS
Age male Symptom score
Measured: three months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2021
- Study start1 Oct 2017
- Primary completion1 Aug 2021
- Study completion1 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Testosterone DeficiencyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized Controlled Trial
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Moinhos de Vento
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital de Clinicas de Porto Alegre
- Responsible party
- Sponsor
- Investigators
- Brasil S Neto, MD, PhD, Study chair, Hospital de Clínicas Porto AlegreCaio S Schmitt, MD, Principal investigator, Hospital Moinhos de Vento and Hospital de Clínicas Porto Alegre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05019859
- Sponsor's protocol ID
- HMoinhosVento
- Status last verified
- Jul 2021
- First submitted
- 18 Aug 2021
- Last updated
- 2 Jun 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of a Low Carb Diet on Erectile Function and Serem Testosterone in Men With Metabolic Syndrome
- ClinicalTrials.gov ID
- NCT05019859
- Acronym / sponsor ID
- HMoinhosVento
- Keywords
- low carb diet, hypogonadism, metabolic syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Hospital Moinhos de VentoUniversity, hospital or other
- Collaborators
- Hospital de Clinicas de Porto Alegre
- Study start
- 1 Oct 2017 (actual)
- Primary completion
- 1 Aug 2021 (actual)
- Study completion
- 1 Dec 2021 (actual)
- First posted
- 25 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized Controlled Trial
| Arm | Type | Receives |
|---|---|---|
| Intervention | Active comparator | Behavioral: low carb dietlow carb diet |
| Control | No intervention | –traditional low fat diet |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- metabolic syndrome, serum testosterone level below 300 ng/dL
Key exclusion criteria (1 listed)
- active cancer, diet allergies, psychological incapability
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| low carb dietlow carb diet | Behavioural | Intervention |
Primary outcome
testosterone
Time frame: three months
serum total testosterone level
2 secondary outcomes
IIEF 5
Time frame: three months
AMS
Time frame: three months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Brasil S Neto, MD, PhD study chair
Hospital de Clínicas Porto Alegre
Caio S Schmitt, MD principal investigator
Hospital Moinhos de Vento and Hospital de Clínicas Porto Alegre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing low carb diet in people with Testosterone Deficiency and Metabolic Syndrome, run by Hospital Moinhos de Vento at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
testosterone (time frame: three months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jun 2022.