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Clinical Trial to Evaluate the Effect of a Probiotic Product on Weight
Bu çalışma, bir probiyotik ürünün kilo üzerindeki etkisini incelemiştir. Çalışmaya, beden kitle indeksi 25,0-34,9 arasında (fazla kilolu ya da tip I obezite) olan, 18 yaş ve üzeri erkek ve kadınlar alınmış; katılımcılara probiyotik ya da plasebo verilmiştir. Çalışma faz uygulanmayan bir çalışmadır ve tamamlanmıştır.
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: * Men and women aged ≥ 18 years. * Body Mass Index (BMI) between 25.0 and 34.9 (overweight or obesity type I). * Commitment to maintaining a lifestyle, including diet and sports habits, constant throughout the study. * Signing of informed consent. Exclusion Criteria: * Subjects with diabetes (type I or II), hypothyroidism or other diseases that may promote weight gain. * Presence of other serious pathologies, including cancer or autoimmune diseases, or any other that, at the medical discretion of the investigator, may influence the results of the study. * Subjects who have participated in a weight loss program or who have substantially modified their lifestyle habits (diet, physical exercise) during the previous 3 months. * Treatment with antibiotics in the previous 4 weeks. * Consumption of products or drugs intended for weight loss or satiety control, or that may influence weight in the previous 4 weeks. * Consumption of products containing probiotics in the previous 2 months. * Contraindication to taking the product under investigation, or allergy or intolerance to any of its ingredients. * In the case of women: pregnancy or breastfeeding, or plans to become pregnant during the course of the study.