Weight Loss Impact on Male Fertility
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|ClinicalTrials.gov Identifier: NCT04186767|
Recruitment Status : Recruiting
First Posted : December 5, 2019
Last Update Posted : December 5, 2019
|Condition or disease||Intervention/treatment||Phase|
|Obesity Sub Fertility, Male Metabolic Syndrome||Dietary Supplement: Very Low Carb Ketogenic Diet||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||Prospective, unicentre, single group|
|Masking:||None (Open Label)|
|Official Title:||Significative Weight Loss Impact on Oxidative Stress, Metabolic, Hormonal, Inflammatory and Seminal Parameters of Obese Men.|
|Actual Study Start Date :||January 10, 2019|
|Estimated Primary Completion Date :||January 2020|
|Estimated Study Completion Date :||January 2020|
|Experimental: Weight loss||
Dietary Supplement: Very Low Carb Ketogenic Diet
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.
- 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
- Metabolic response [ Time Frame: Six months ]To evaluate the metabolic parameters lipid and glycemic profiles before and after intervention.
- Hormonal measurements [ Time Frame: Six months ]To evaluate hormonal parameters total testosterone, LH, FSH, insulin before and after intervention.
- Inflamatory response [ Time Frame: Six months ]To evaluate cytokines TNFa and IL-6 response before and after intervention.
- Adipose tissue evaluation [ Time Frame: Six months ]To evaluate adipokines: leptin, adiponectin, UCP-1, FGF21, irisin and PGC1a measures before and after intervention.
- Microbiota evaluation [ Time Frame: Six months ]Evaluate the whole intestinal metagenomics before and after the intervention
- Epigenetic evaluation [ Time Frame: Six months ]To evaluate the epigenetic methylation profile of spermatozoa before and after the intervention
- Body composition changes [ Time Frame: Six months ]Apply body composition digital analyser pre and post intervention.
- Brow tissue study [ Time Frame: Six months ]Thermodynamic evaluation of brown adipose tissue using infrared thermography.
- Adipose tissue toxins study [ Time Frame: Six months ]Persistent organic pollutants measure: 2,3,7,8- tetrachlorodibenzo-p-dioxin (TCDD)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04186767
|Contact: Alessandra C Renck, MDfirstname.lastname@example.org|
|Hospital das Clinicas da Faculdade de Medicina da USP||Recruiting|
|São Paulo, Sao Paulo, Brazil, 05403000|
|Contact: Alessandra C Renck, MD +5511981211114 email@example.com|