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Effect of Ancestry Supplementation in Subjects With Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD)
Bu çalışma, Ancestry adlı bir takviyenin, metabolik disfonksiyonla ilişkili steatotik karaciğer hastalığı (metabolic dysfunction-associated steatotic liver disease, MASLD) olan kişilerdeki etkisini plasebo ile karşılaştırarak değerlendirmektedir. Çalışmaya, 18-60 yaş arası, MASLD tanısı ve obezite bulunan Meksikalı mestizo yetişkinler katılabilmektedir. Çalışma faz uygulanmayan bir çalışmadır ve davetle katılım almaktadır.
Yukarıdaki özet, resmî kaydın sade dile aktarılmış halidir. Orijinal İngilizce başlık referans için gösterilir.
Kriterler ClinicalTrials.gov kaydından orijinal İngilizce haliyle alınmıştır. Uygunluk kararını yalnızca deneyi yürüten ekip verebilir.
Inclusion Criteria: * Mexican mestizo adults of both sexes between 18 to 60 years old * Diagnosis of MASLD according to the criteria established by the American Association for the Study of Liver Diseases * Controlled Attenuation Parameter (CAP) score \>248 dB/m, liver stiffness \<14 kPa according to FibroScan Expert 630 (Echosens, Paris, France) * Obesity diagnosed by body fat percentage * Bristol stool scale type 3-4 * Physical inactivity according to the International Physical Activity Questionnaire (IPAQ) * Alcohol consumption \<20 grams/day for women and \<30 grams/day for men * Signed informed consent Exclusion Criteria: * Severe gastrointestinal diseases (e.g., chronic constipation, Crohn's disease, celiac disease, ulcerative colitis, irritable bowel syndrome, diverticulosis, etc.), autoimmune diseases, and malignant neoplasms * Current or prior 6 weeks consumption of probiotic formulations * Current or prior 2 months consumption of antibiotics or antiparasitic drugs before the start of the study * Current consumption of dietary supplements (omega-3 fatty acids, thermogenics, protein, teas, etc.) * Frequent consumption (greater than or equal to twice a week) of anti-inflammatory drugs, analgesics, or medications that alter normal intestinal function (e.g., laxatives, enemas, antidiarrheal agents, etc.) * Pregnant women, women planning pregnancy, or breastfeeding women * Weight loss greater than three kilograms in the last month * Tobacco consumption * Allergy or intolerance to cacao, nopal, or crickets * Previous malabsorptive bariatric surgery (gastric bypass, sleeve gastrectomy), restrictive bariatric surgery (adjustable gastric band), or cosmetic surgical procedures (liposuction, lipo-sculpture, abdominoplasty, etc.) in the last 2 years