protocolSection identificationModule nctId: NCT06278701, orgStudyIdInfo id: 2024-003-01, briefTitle: The Effect of Late-evening Snacks on Patients With Primary Hepatocellular Carcinoma After Hepatectomy, statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2023-11-01, primaryCompletionDateStruct date: 2025-01-31, completionDateStruct date: 2025-07-30, studyFirstPostDateStruct date: 2024-02-26, lastUpdatePostDateStruct date: 2024-02-26, sponsorCollaboratorsModule leadSponsor name: DU Yao, class: OTHER, descriptionModule briefSummary: Late-evening snacks, in which a portion of food is moved to bedtime while the total amount of food eaten per day remains unchanged, can effectively improve the metabolic state of accelerated catabolism.The goal of this clinical trial is to learn about the effects of late-evening snacks on health conditions of hepatocellular carcinoma patients who underwent hepatectomy, and to further explore the effects of late-evening snacks on patients' metabolic patterns. The main question it aims to answer are: • the effect of late-evening snacks on the nutritional status of hepatic resection patients with hepatocellular carcinoma;* the effect of late-evening snacks on the recovery of liver function in liver cancer hepatectomy patients;* the effect of late-evening snacks on the complication rate of hepatic resection patients with hepatocellular carcinoma;* the effect of late-evening snacks on long-term quality of life of hepatic resection patients with hepatocellular carcinoma;* the effect of late-evening snacks on the metabolic pattern of hepatic resection patients with hepatocellular carcinoma.After learning about the 2 dietary modalities of the late-evening snacks and regular diet, patients will be placed in the different groups according to your preference. Patients who enter the test group will have additional meal 1h before bedtime every day, while patients in the control group will have normal diet. Patients will be asked to :* eat 1h before bedtime;* follow the doctor's instructions during their stay in the hospital;* have follow-up examinations at 1 month, 3 months and 6 months after the operation, after which blood samples will be collected for metabolite testing., conditionsModule conditions: Liver Neoplasms, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NON_RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: This study utilizes a grouping method based on patient preference. You will learn about the 2 dietary modalities, the late-evening snacks and the regular diet, and then you will be placed in the different groups according to your preference. Patients who volunteer for the 1h bedtime meal will be in the test group and those who volunteer for the regular diet will be in the control group. Dietary counseling and follow-up visits will be conducted in both groups, the difference being the presence or absence of the 1h bedtime meal pattern., primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: NONE, enrollmentInfo count: 106, type: ESTIMATED, armsInterventionsModule interventions name: late-evening snacks, outcomesModule primaryOutcomes measure: Albumin rising, secondaryOutcomes measure: Prealbumin rising, secondaryOutcomes measure: Decrease in Alanine Aminotransferase, secondaryOutcomes measure: Decrease in Aspartate Aminotransferase, secondaryOutcomes measure: Decrease in Cholinesterase, secondaryOutcomes measure: Decrease in Total bilirubin, secondaryOutcomes measure: Lower total hospitalization costs, secondaryOutcomes measure: Relapse-Free Survival, secondaryOutcomes measure: Improved quality of life, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Drum Tower Hospital, Medical School of Nanjing University, city: Nanjing, state: Jiangsu, zip: 210008, country: China, geoPoint lat: 32.06167, lon: 118.77778, documentSection largeDocumentModule largeDocs typeAbbrev: Prot_SAP, hasProtocol: True, hasSap: True, hasIcf: False, label: Study Protocol and Statistical Analysis Plan, date: 2023-12-22, uploadDate: 2024-02-02T09:22, filename: Prot_SAP_000.pdf, size: 743937, largeDocs typeAbbrev: ICF, hasProtocol: False, hasSap: False, hasIcf: True, label: Informed Consent Form, date: 2023-12-22, uploadDate: 2024-02-04T04:41, filename: ICF_001.pdf, size: 292546, hasResults: False