protocolSection identificationModule nctId: NCT06275347, orgStudyIdInfo id: 19CI 30 087 041, secondaryIdInfos 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, statusModule overallStatus: COMPLETED, startDateStruct date: 2021-01-15, primaryCompletionDateStruct date: 2021-12-30, completionDateStruct date: 2023-05-25, studyFirstPostDateStruct date: 2024-02-23, lastUpdatePostDateStruct date: 2024-02-23, sponsorCollaboratorsModule leadSponsor name: Universidad Veracruzana, class: OTHER, descriptionModule 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, conditionsModule conditions: Obesity, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: A Randomized Clinical Trial was conducted in patients with obesity type I patients, primaryPurpose: TREATMENT, maskingInfo 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, enrollmentInfo count: 88, type: ACTUAL, armsInterventionsModule interventions name: Low-fat normoprotein Controlled Ketogenic Diet., interventions name: Hypocaloric Balanced Diet, outcomesModule primaryOutcomes measure: Evaluate the efficacy of this nutritional intervention, primaryOutcomes measure: Volume of total body tissue corresponding to muscle, primaryOutcomes measure: Percentage of body weight made up of adipose tissue, primaryOutcomes measure: Visceral Fat, primaryOutcomes measure: Bone mass, primaryOutcomes measure: Total body water, primaryOutcomes measure: Waist circumference, primaryOutcomes measure: Hip circumference, primaryOutcomes measure: Muscular strenght, primaryOutcomes measure: Weight, primaryOutcomes measure: Height, primaryOutcomes measure: BMI Body index mass, secondaryOutcomes measure: Hemoglobin, secondaryOutcomes measure: Hematocrit, secondaryOutcomes measure: Leukocytes, secondaryOutcomes measure: Fasting Blood Glucose, secondaryOutcomes measure: Glycated hemoglobin (HbA1c), secondaryOutcomes measure: Insulin, secondaryOutcomes measure: Creatinine, secondaryOutcomes measure: Urea, secondaryOutcomes measure: Uric acid, secondaryOutcomes measure: Sodium, secondaryOutcomes measure: Potassium, secondaryOutcomes measure: Calcium, secondaryOutcomes measure: Phosphorus, secondaryOutcomes measure: Magnesium, secondaryOutcomes measure: Albumin, secondaryOutcomes measure: Direct bilirubin, secondaryOutcomes measure: Indirect bilirubin, secondaryOutcomes measure: Total bilirubin, secondaryOutcomes measure: Alanine aminotransferase, secondaryOutcomes measure: Aspartate Amino Transferase, secondaryOutcomes measure: Total cholesterol, secondaryOutcomes measure: Triglycerides, secondaryOutcomes measure: High Density Lipoproteins, secondaryOutcomes measure: Low Density lipoproteins, secondaryOutcomes measure: Protein C Reactive, secondaryOutcomes measure: Thyroid stimulating hormone, secondaryOutcomes measure: Triiodothyronine, secondaryOutcomes measure: Thyroxine, secondaryOutcomes measure: Cholecalciferol, secondaryOutcomes measure: Gasometric variables, Partial pressure of oxygen (PaO2), secondaryOutcomes measure: HCO3 (Bicarbonate ion plasma concentration), secondaryOutcomes measure: Arterial pH, secondaryOutcomes measure: Lactic acid, otherOutcomes measure: Adherence to this nutritional intervention, otherOutcomes measure: Satisfaction survey, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 61 Years, stdAges: ADULT, contactsLocationsModule locations facility: Francisco J Nachón García, city: Ciudad de Mexico, country: Mexico, geoPoint lat: 19.42847, lon: -99.12766, documentSection largeDocumentModule largeDocs 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, largeDocs 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