ObesityNCT04186767
Weight Loss Impact on Male Fertility
A study testing Very Low Carb Ketogenic Diet in people with Obesity and Sub Fertility, Male, run by University of Sao Paulo at 1 site in Brazil.
Trial summary
This is a prospective non-randomized unicentric clinical trial, characterized by the inclusion of obese (BMI> 35) male with subfertility (sperm count showing low sperm counts and / or motility and / or morphology and / or DNA fragmentation). Read more about this study
- Who is it for?
- Ages 18 to 55 years, men only
- Conditions the study is for
- Obesity, Sub Fertility, Male, Metabolic Syndrome
- What is being tested?
- Very Low Carb Ketogenic Diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteBrazil
- Study dates
- 10 Jan 2019to 22 Jan 2023
- 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 to 55 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- Obesity in male patients
- Metabolic Syndrome (NCEP-ATP III)
- Alteration of some of the seminal parameters evaluated in conventional seminal analysis
Who cannot join
- Other causes of hypogonadotrophic hypogonadism
- Hypergonadotrophic hypogonadism
- Contraindications for performance of ketogenic diet:
- Type 1 or type 2 diabetes mellitus in insulin use
- Food drive
- Alcoholism or drug addiction
Show all 16Show fewer
- Severe psychiatric illness
- Use of coumarin anticoagulants
- Hepatic insufficiency
- Severe renal impairment
- Hematologic diseases
- Cancer in activity,
- Cardiovascular or cerebrovascular diseases (arrhythmias, recent myocardial infarction, unstable angina, decompensated heart failure, recent stroke)
- Gout
- Renal or biliary lithiasis
- Major depression or other serious psychiatric illness.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Hospital das Clinicas da Faculdade de Medicina da USP
São Paulo, São Paulo, 05403000
About this study
Official title: Significative Weight Loss Impact on Oxidative Stress, Metabolic, Hormonal, Inflammatory and Seminal Parameters of Obese Men.
This is a prospective non-randomized unicentric clinical trial, characterized by the inclusion of obese (BMI> 35) male with subfertility (sperm count showing low sperm counts and / or motility and / or morphology and / or DNA fragmentation). Patients selected at the endocrinology obesity HC-FMUSP outpatient will be submitted to very low calorie diet (VLCK) for 6 months, being reassessed clinically and laboratorially monthly.
- Conditions
- Obesity, Sub Fertility, Male, Metabolic Syndrome
- Being tested
- Very Low Carb Ketogenic Diet
- Medical subject headings
- Obesity, Infertility, Male, Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Very Low Carb Ketogenic DietDietary supplement
Patients will be submitted to very low-calorie ketogenic dietary intervention (VLCK) according to the recommendations of the Pronokal® Method program including lifestyle and physical activity guidelines. The ketogenic stage (phase 1-3) consists of a VLCD diet (600-800 kcal / d), with low carbohydrate intake and lipids. The amount of high biological value proteins ranges from 0.8 to 1.2 g / kg of body weight / day. This first stage (ketogenic) is maintained until the patient reaches the goal of reducing the target weight by 80% to be reduced, being variable in time, according to the response of each patient. After this period, it evolved to a non-ketogenic stage, initiating the hypocaloric diet (800 to 1500 Kcal), with progressive introduction of other food groups, reducing weight more slowly. The maintenance stage consists of a balanced diet, ranging from 1500 to 2000 Kcal.
| Study group | Role | What they receive |
|---|---|---|
| Weight loss | Experimental | Not described Receives: Dietary Supplement: Very Low Carb Ketogenic Diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Seminal evaluation
Spermatic counting will be combined to report
Measured: Six months
Seminal evaluation
Spermatic motility will be combined to report
Measured: Six months
Seminal evaluation
DNA fragmentation will be combined to report
Measured: Six months
Secondary outcomes (9)
Metabolic response
To evaluate the metabolic parameters lipid and glycemic profiles before and after intervention.
Measured: Six months
Hormonal measurements
To evaluate hormonal parameters total testosterone, LH, FSH, insulin before and after intervention.
Measured: Six months
Inflamatory response
To evaluate cytokines TNFa and IL-6 response before and after intervention.
Measured: Six months
Adipose tissue evaluation
To evaluate adipokines: leptin, adiponectin, UCP-1, FGF21, irisin and PGC1a measures before and after intervention.
Measured: Six months
Microbiota evaluation
Evaluate the whole intestinal metagenomics before and after the intervention
Measured: Six months
Epigenetic evaluation
To evaluate the epigenetic methylation profile of spermatozoa before and after the intervention
Measured: Six months
Body composition changes
Apply body composition digital analyser pre and post intervention.
Measured: Six months
Brow tissue study
Thermodynamic evaluation of brown adipose tissue using infrared thermography.
Measured: Six months
Adipose tissue toxins study
Persistent organic pollutants measure: 2,3,7,8- tetrachlorodibenzo-p-dioxin (TCDD)
Measured: Six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2019
- Study start10 Jan 2019
- Primary completion20 Aug 2020
- Study completion22 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by University of Sao PauloThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Model description
- Prospective, unicentre, single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alessandra Renck, University of Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04186767
- Sponsor's protocol ID
- 86158918.4.0000.0068
- Status last verified
- Feb 2023
- First submitted
- 21 Apr 2019
- Last updated
- 28 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Significative Weight Loss Impact on Oxidative Stress, Metabolic, Hormonal, Inflammatory and Seminal Parameters of Obese Men.
- ClinicalTrials.gov ID
- NCT04186767
- Acronym / sponsor ID
- 86158918.4.0000.0068
- Conditions
- Obesity, Sub Fertility, Male, Metabolic Syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Study start
- 10 Jan 2019 (actual)
- Primary completion
- 20 Aug 2020 (actual)
- Study completion
- 22 Jan 2023 (actual)
- First posted
- 5 Dec 2019 (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.
This is a prospective non-randomized unicentric clinical trial, characterized by the inclusion of obese (BMI> 35) male with subfertility (sperm count showing low sperm counts and / or motility and / or morphology and / or DNA fragmentation). Patients selected at the endocrinology obesity HC-FMUSP outpatient will be submitted to very low calorie diet (VLCK) for 6 months, being reassessed clinically and laboratorially monthly.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Prospective, unicentre, single group
| Arm | Type | Receives |
|---|---|---|
| Weight loss | Experimental | Dietary Supplement: Very Low Carb Ketogenic Diet |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Obesity in male patients
- Metabolic Syndrome (NCEP-ATP III)
- Alteration of some of the seminal parameters evaluated in conventional seminal analysis
Key exclusion criteria (16 listed)
- Other causes of hypogonadotrophic hypogonadism
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 |
|---|---|---|
| Very Low Carb Ketogenic DietPatients will be submitted to very low-calorie ketogenic dietary intervention (VLCK) according to the recommendations of the Pronokal® Method program including lifestyle and physical activity guidelines. The ketogenic stage (phase 1-3) consists of a VLCD diet (600-800 kcal / d), with low carbohydrate intake and lipids. The amount of high biological value proteins ranges from 0.8 to 1.2 g / kg of body weight / day. This first stage (ketogenic) is maintained until the patient reaches the goal of reducing the target weight by 80% to be reduced, being variable in time, according to the response of each patient. After this period, it evolved to a non-ketogenic stage, initiating the hypocaloric diet (800 to 1500 Kcal), with progressive introduction of other food groups, reducing weight more slowly. The maintenance stage consists of a balanced diet, ranging from 1500 to 2000 Kcal. | Dietary supplement | Weight loss |
Primary outcome
Seminal evaluation
Time frame: Six months
Spermatic counting will be combined to report
Seminal evaluation
Time frame: Six months
Spermatic motility will be combined to report
Seminal evaluation
Time frame: Six months
DNA fragmentation will be combined to report
9 secondary outcomes
Metabolic response
Time frame: Six months
Hormonal measurements
Time frame: Six months
Inflamatory response
Time frame: Six months
Adipose tissue evaluation
Time frame: Six months
Microbiota evaluation
Time frame: Six months
Epigenetic evaluation
Time frame: Six months
Body composition changes
Time frame: Six months
Brow tissue study
Time frame: Six months
Adipose tissue toxins study
Time frame: Six 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 28 Feb 2023.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Very Low Carb Ketogenic Diet in people with Obesity and Sub Fertility, Male, run by University of Sao Paulo 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 3 inclusion and 16 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 28 Feb 2023. 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?
Seminal evaluation (time frame: Six months). The study lists 3 primary outcomes in all. 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 28 Feb 2023.