Healthy volunteers
Conditions
Interventions
Group I ADIPONEXIN (Experimental): 2 capsules of ADIPONEXIN will be administered every 12 hours, by oral route, for 90 days with meals containing oil or fats (4 capsules in total). The capsule is a pr
Sponsors
"Hermanos Ameijeiras" Surgical Clinical Hospital
Eligibility
Sex/Gender
All
Age
19 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. A healthy adult between 19 and 75 years old. 2. Have a Body Mass Index (BMI) equal to or greater than 25. 3. Have a waist circumference equal to or greater than 37 inches for men and 31.5 inches for women. 4. Not be undergoing weight-loss treatments, such as medications, diets, exercise, bariatric surgery, or GLP-1 analogues
Exclusion criteria
Exclusion criteria: 1. Inability to provide informed consent. 2. Changes in diet or exercise during the study. 3. Consumption of functional foods enriched with nutritional supplements or probiotics in the six months prior to the study. 4. Shellfish allergy. 5. Use of antibiotics in the 15 days prior to the study or probiotic supplements during the study. 6. Presence of kidney failure, cardiovascular disease, uncontrolled hypertension, diabetes, smoking, or any precluding medical condition. 7. History of bariatric surgery or weight loss greater than 3 kg in the past two months. 8. Excessive alcohol consumption, according to the criteria established by DSM-5 or ICD-10
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Bioimpedance Measurements (Using the TANITA TANITARD-545 InnerScan PRO Segmental instrument will be measured the Subcutaneous fat vs. abdominal visceral fat, Body Mass Index (BMI), Waist circumference and Lean muscle mass). Mesurement time: At baseline, 45 days and, 90 days | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Clinical chemistry parameters (A Cobas 600 modular immunoassay autoanalyzer (Roche Diagnostics) will be used. The analysis will be performed on serum samples in Fasting glucose (mmol/L), Creatinine (umol/L), Cholesterol (mmol/L), Triglycerides (mmol/L), C-Reactive Protein-hs-CRP-(mg/L), IL-6 (pg/mL), Insulin (U/ml), TSH (mIU/L), Hb A1C(%), Testosterone (nmol/L), Estradiol F (pg/ML)). Measurement time: At baseline and, 90 days 2. Leptin (It will be determined by an ELISA test Human Leptin ELISA Kit (abcam ab108879)). Measurement time: At baseline and, 90 days 3. Adiponectin (It will be determined using the Human Adiponectin ELISA Kit (abcam ab314604)). Measurement time: At baseline and, 90 days 4. Oxytocin (It will be determined using the Oxytocin ELISA Kit (abcamab133050)). Measurement time: At baseline and, 90 days 5. Serum LPS levels (It will be determined using the ELISA test using the commercial ToxinSensorTM Endotoxin Detection System Version 11242021 kit). Measurement time: At baseline and, 90 days 6. Fecal Calprotectin levels (It will be determined using the fCAL test, 200T, cobas c 501/502, PCh 200 tests). Measurement time: At baseline and, 90 days 7. Hemodynamic parameters (Heart rate (beats per minute), Blood pressure (mmHg)). Measurement time: At baseline and, 90 days 8. Bacterial composition of the specific fecal microbiome (It will be determined by sequence studies of the 16S ribosome subunit (16S rRNA V3-V4) in stool samples. Taxonomic Profile and compositional analysis will be used. The taxonomic profile analysis will be performed using PICRUSt to determine the Inflammation Index, Alpha Diversity and Beta Diversity. The compositional analysis will be performed using the prediction analysis of functional markers (orthologous genes) from the study of the microbiome using LEfSe (Linear discriminant analysis Effect Size)). Measurement time: At baseline and, 90 days 9. Quality of Life (SF-36 Health Survey in Spanish). Measurement time: At baseline and, | — |
Countries
Cuba
Contacts
Public ContactGissel Garcia Menendez
"Hermanos Ameijeiras" Surgical Clinical Hospital
Outcome results
None listed