nctId: NCT06275347 id: 19CI 30 087 041 id: 1/1142021 type: OTHER domain: Comite del Centro de alta especialidad del Estado de Veracruz briefTitle: Very Low Calorie Ketogenic Low-fat Diet (VLCKLFD) acronym: Zelé2021 overallStatus: COMPLETED date: 2021-01-15 date: 2021-12-30 date: 2023-05-25 date: 2024-02-23 date: 2024-02-23 name: Universidad Veracruzana class: OTHER briefSummary: This study aimed to assess the efficacy and safety of the Zélé program, a controlled ketogenic diet, for weight loss and maintenance. It involved a randomized clinical trial with participants aged 18-60, BMI between 30-34.9 kg/m², and no severe health issues conditions: Obesity studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: A Randomized Clinical Trial was conducted in patients with obesity type I patients primaryPurpose: TREATMENT masking: DOUBLE maskingDescription: Eligible patients were assigned to a one of the four VIME Weight Loss and Wellness Center for management and follow up according to their preference, a sequential number in inclusion order was given, with all the patients coded with a 4-digit number. This code was sent to the people in the food production plant where the patients were randomized in a double blinded study, with a 2:1 allocation for low-fat, normo-protein, controlled ketogenic diet (Zélé method) or low calories diet whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER count: 88 type: ACTUAL name: Low-fat normoprotein Controlled Ketogenic Diet. name: Hypocaloric Balanced Diet measure: Evaluate the efficacy of this nutritional intervention measure: Volume of total body tissue corresponding to muscle measure: Percentage of body weight made up of adipose tissue measure: Visceral Fat measure: Bone mass measure: Total body water measure: Waist circumference measure: Hip circumference measure: Muscular strenght measure: Weight measure: Height measure: BMI Body index mass measure: Hemoglobin measure: Hematocrit measure: Leukocytes measure: Fasting Blood Glucose measure: Glycated hemoglobin (HbA1c) measure: Insulin measure: Creatinine measure: Urea measure: Uric acid measure: Sodium measure: Potassium measure: Calcium measure: Phosphorus measure: Magnesium measure: Albumin measure: Direct bilirubin measure: Indirect bilirubin measure: Total bilirubin measure: Alanine aminotransferase measure: Aspartate Amino Transferase measure: Total cholesterol measure: Triglycerides measure: High Density Lipoproteins measure: Low Density lipoproteins measure: Protein C Reactive measure: Thyroid stimulating hormone measure: Triiodothyronine measure: Thyroxine measure: Cholecalciferol measure: Gasometric variables, Partial pressure of oxygen (PaO2) measure: HCO3 (Bicarbonate ion plasma concentration) measure: Arterial pH measure: Lactic acid measure: Adherence to this nutritional intervention measure: Satisfaction survey sex: ALL minimumAge: 18 Years maximumAge: 61 Years stdAges: ADULT facility: Francisco J Nachón García city: Ciudad de Mexico country: Mexico lat: 19.42847 lon: -99.12766 typeAbbrev: Prot_SAP hasProtocol: True hasSap: True hasIcf: False label: Study Protocol and Statistical Analysis Plan date: 2021-04-23 uploadDate: 2024-02-16T19:37 filename: Prot_SAP_000.pdf size: 549651 typeAbbrev: ICF hasProtocol: False hasSap: False hasIcf: True label: Informed Consent Form date: 2021-04-23 uploadDate: 2024-01-14T23:04 filename: ICF_001.pdf size: 249137 hasResults: False