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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;
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 :
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| the control group | No Intervention | Patients who voluntarily accept a regular diet and do not eat again 1h before bedtime | |
| the test group | Experimental | Patients who voluntarily accepted to have an additional meal 1h before bedtime (total calories 200-275kcal, protein 11.5g-18g, complex carbohydrates 25-55g). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| late-evening snacks | Other | have an additional meal 1h before bedtime (total calories 200-275kcal, protein 11.5g-18g, complex carbohydrates 25-55g). |
|
| Measure | Description | Time Frame |
|---|---|---|
| Albumin rising | Serum albumin levels in patients at each time point | Day 1 of admission/Post-operative day 6/1 month postoperative/3 months postoperative/6 months postoperative |
| Measure | Description | Time Frame |
|---|---|---|
| Prealbumin rising | Serum levels of prealbumin in patients at each time point | Day 1 of admission/Post-operative day 6/1 month postoperative/3 months postoperative/6 months postoperative |
| Decrease in Alanine Aminotransferase |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Yao Du, Master | Drum Tower Hospital, Medical School of Nanjing University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Drum Tower Hospital, Medical School of Nanjing University | Nanjing | Jiangsu | 210008 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33538338 | Background | Sung H, Ferlay J, Siegel RL, Laversanne M, Soerjomataram I, Jemal A, Bray F. Global Cancer Statistics 2020: GLOBOCAN Estimates of Incidence and Mortality Worldwide for 36 Cancers in 185 Countries. CA Cancer J Clin. 2021 May;71(3):209-249. doi: 10.3322/caac.21660. Epub 2021 Feb 4. | |
| 29395269 | Background | Allemani C, Matsuda T, Di Carlo V, Harewood R, Matz M, Niksic M, Bonaventure A, Valkov M, Johnson CJ, Esteve J, Ogunbiyi OJ, Azevedo E Silva G, Chen WQ, Eser S, Engholm G, Stiller CA, Monnereau A, Woods RR, Visser O, Lim GH, Aitken J, Weir HK, Coleman MP; CONCORD Working Group. Global surveillance of trends in cancer survival 2000-14 (CONCORD-3): analysis of individual records for 37 513 025 patients diagnosed with one of 18 cancers from 322 population-based registries in 71 countries. Lancet. 2018 Mar 17;391(10125):1023-1075. doi: 10.1016/S0140-6736(17)33326-3. Epub 2018 Jan 31. |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 22, 2023 | Feb 2, 2024 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Dec 22, 2023 | Feb 4, 2024 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D008113 | Liver Neoplasms |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
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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.
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Serum levels of alanine aminotransferase in patients at each time point
| Day 1 of admission/Post-operative day 6/1 month postoperative/3 months postoperative/6 months postoperative |
| Decrease in Aspartate Aminotransferase | Serum levels of aspartate aminotransferase in patients at each time point | Day 1 of admission/Post-operative day 6/1 month postoperative/3 months postoperative/6 months postoperative |
| Decrease in Cholinesterase | Serum levels of cholinesterase in patients at each time point | Day 1 of admission/Post-operative day 6/1 month postoperative/3 months postoperative/6 months postoperative |
| Decrease in Total bilirubin | Serum levels of total bilirubin in patients at each time point | Day 1 of admission/Post-operative day 6/1 month postoperative/3 months postoperative/6 months postoperative |
| Lower total hospitalization costs | Total cost from patient hospitalization to discharge | From admission to dischargeļ¼an average of 1 month |
| Relapse-Free Survival | Time from when the patient achieved complete remission after hepatectomy to the time of recurrence or cutoff for follow-up | From the time the patient underwent hepatectomy until the date of first recording to the date of progression or death from any cause, whichever comes first, assessed up to 2 years |
| Improved quality of life | Patients completed EORTC QLQ-C30 at various time points | 1 month postoperative/3 months postoperative/6 months postoperative |
| 31267302 | Background | Tsilimigras DI, Bagante F, Sahara K, Moris D, Hyer JM, Wu L, Ratti F, Marques HP, Soubrane O, Paredes AZ, Lam V, Poultsides GA, Popescu I, Alexandrescu S, Martel G, Workneh A, Guglielmi A, Hugh T, Aldrighetti L, Endo I, Pawlik TM. Prognosis After Resection of Barcelona Clinic Liver Cancer (BCLC) Stage 0, A, and B Hepatocellular Carcinoma: A Comprehensive Assessment of the Current BCLC Classification. Ann Surg Oncol. 2019 Oct;26(11):3693-3700. doi: 10.1245/s10434-019-07580-9. Epub 2019 Jul 2. |
| 32716739 | Background | Finn RS, Ikeda M, Zhu AX, Sung MW, Baron AD, Kudo M, Okusaka T, Kobayashi M, Kumada H, Kaneko S, Pracht M, Mamontov K, Meyer T, Kubota T, Dutcus CE, Saito K, Siegel AB, Dubrovsky L, Mody K, Llovet JM. Phase Ib Study of Lenvatinib Plus Pembrolizumab in Patients With Unresectable Hepatocellular Carcinoma. J Clin Oncol. 2020 Sep 10;38(26):2960-2970. doi: 10.1200/JCO.20.00808. Epub 2020 Jul 27. |
| 25775062 | Background | Liu PH, Hsu CY, Hsia CY, Lee YH, Huang YH, Chiou YY, Lin HC, Huo TI. Surgical Resection Versus Radiofrequency Ablation for Single Hepatocellular Carcinoma </= 2 cm in a Propensity Score Model. Ann Surg. 2016 Mar;263(3):538-45. doi: 10.1097/SLA.0000000000001178. |
| 26725059 | Background | Borhofen SM, Gerner C, Lehmann J, Fimmers R, Gortzen J, Hey B, Geiser F, Strassburg CP, Trebicka J. The Royal Free Hospital-Nutritional Prioritizing Tool Is an Independent Predictor of Deterioration of Liver Function and Survival in Cirrhosis. Dig Dis Sci. 2016 Jun;61(6):1735-43. doi: 10.1007/s10620-015-4015-z. Epub 2016 Jan 2. |
| 36523946 | Background | Rong W, Xia H, Zhang K, Zhang Y, Tao C, Wu F, Wang L, Zhang H, Sun G, Wu J. Serum metabolic effects of corn oligopeptides with 7-day supplementation on early post-surgery primary liver cancer patients: a double-blind randomized controlled trial. Hepatobiliary Surg Nutr. 2022 Dec;11(6):834-847. doi: 10.21037/hbsn-21-116. |
| 34242915 | Background | Weimann A, Braga M, Carli F, Higashiguchi T, Hubner M, Klek S, Laviano A, Ljungqvist O, Lobo DN, Martindale RG, Waitzberg D, Bischoff SC, Singer P. ESPEN practical guideline: Clinical nutrition in surgery. Clin Nutr. 2021 Jul;40(7):4745-4761. doi: 10.1016/j.clnu.2021.03.031. Epub 2021 Apr 19. |
| 30765200 | Result | Huang TH, Hsieh CC, Kuo LM, Chang CC, Chen CH, Chi CC, Liu CH. Malnutrition associated with an increased risk of postoperative complications following hepatectomy in patients with hepatocellular carcinoma. HPB (Oxford). 2019 Sep;21(9):1150-1155. doi: 10.1016/j.hpb.2019.01.003. Epub 2019 Feb 11. |
| 33679050 | Result | Puri P, Dhiman RK, Taneja S, Tandon P, Merli M, Anand AC, Arora A, Acharya SK, Benjamin J, Chawla YK, Dadhich S, Duseja A, Eapan CE, Goel A, Kalra N, Kapoor D, Kumar A, Madan K, Nagral A, Pandey G, Rao PN, Saigal S, Saraf N, Saraswat VA, Saraya A, Sarin SK, Sharma P, Shalimar, Shukla A, Sidhu SS, Singh N, Singh SP, Srivastava A, Wadhawan M. Nutrition in Chronic Liver Disease: Consensus Statement of the Indian National Association for Study of the Liver. J Clin Exp Hepatol. 2021 Jan-Feb;11(1):97-143. doi: 10.1016/j.jceh.2020.09.003. Epub 2020 Oct 1. |
| 36310325 | Result | Joliat GR, Kobayashi K, Hasegawa K, Thomson JE, Padbury R, Scott M, Brustia R, Scatton O, Tran Cao HS, Vauthey JN, Dincler S, Clavien PA, Wigmore SJ, Demartines N, Melloul E. Guidelines for Perioperative Care for Liver Surgery: Enhanced Recovery After Surgery (ERAS) Society Recommendations 2022. World J Surg. 2023 Jan;47(1):11-34. doi: 10.1007/s00268-022-06732-5. Epub 2022 Oct 30. |
| 30712783 | Result | Plauth M, Bernal W, Dasarathy S, Merli M, Plank LD, Schutz T, Bischoff SC. ESPEN guideline on clinical nutrition in liver disease. Clin Nutr. 2019 Apr;38(2):485-521. doi: 10.1016/j.clnu.2018.12.022. Epub 2019 Jan 16. |
| 23471642 | Result | Amodio P, Bemeur C, Butterworth R, Cordoba J, Kato A, Montagnese S, Uribe M, Vilstrup H, Morgan MY. The nutritional management of hepatic encephalopathy in patients with cirrhosis: International Society for Hepatic Encephalopathy and Nitrogen Metabolism Consensus. Hepatology. 2013 Jul;58(1):325-36. doi: 10.1002/hep.26370. Epub 2013 May 31. |
| 37571408 | Result | Leoni L, Valoriani F, Barbieri R, Pambianco M, Vinciguerra M, Sicuro C, Colecchia A, Menozzi R, Ravaioli F. Unlocking the Power of Late-Evening Snacks: Practical Ready-to-Prescribe Chart Menu for Patients with Cirrhosis. Nutrients. 2023 Aug 5;15(15):3471. doi: 10.3390/nu15153471. |
| 29805447 | Result | Guo YJ, Tian ZB, Jiang N, Ding XL, Mao T, Jing X. Effects of Late Evening Snack on Cirrhotic Patients: A Systematic Review and Meta-Analysis. Gastroenterol Res Pract. 2018 Apr 1;2018:9189062. doi: 10.1155/2018/9189062. eCollection 2018. |
| 30883904 | Result | Chen CJ, Wang LC, Kuo HT, Fang YC, Lee HF. Significant effects of late evening snack on liver functions in patients with liver cirrhosis: A meta-analysis of randomized controlled trials. J Gastroenterol Hepatol. 2019 Jul;34(7):1143-1152. doi: 10.1111/jgh.14665. Epub 2019 May 7. |
| 17234504 | Result | Nakaya Y, Okita K, Suzuki K, Moriwaki H, Kato A, Miwa Y, Shiraishi K, Okuda H, Onji M, Kanazawa H, Tsubouchi H, Kato S, Kaito M, Watanabe A, Habu D, Ito S, Ishikawa T, Kawamura N, Arakawa Y; Hepatic Nutritional Therapy (HNT) Study Group. BCAA-enriched snack improves nutritional state of cirrhosis. Nutrition. 2007 Feb;23(2):113-20. doi: 10.1016/j.nut.2006.10.008. |
| 19285598 | Result | Takeshita S, Ichikawa T, Nakao K, Miyaaki H, Shibata H, Matsuzaki T, Muraoka T, Honda T, Otani M, Akiyama M, Miuma S, Ozawa E, Fujimito M, Eguchi K. A snack enriched with oral branched-chain amino acids prevents a fall in albumin in patients with liver cirrhosis undergoing chemoembolization for hepatocellular carcinoma. Nutr Res. 2009 Feb;29(2):89-93. doi: 10.1016/j.nutres.2008.12.005. |
| 20618455 | Result | Harima Y, Yamasaki T, Hamabe S, Saeki I, Okita K, Terai S, Sakaida I. Effect of a late evening snack using branched-chain amino acid-enriched nutrients in patients undergoing hepatic arterial infusion chemotherapy for advanced hepatocellular carcinoma. Hepatol Res. 2010 Jun;40(6):574-84. doi: 10.1111/j.1872-034X.2010.00665.x. |
| 22380706 | Result | Morihara D, Iwata K, Hanano T, Kunimoto H, Kuno S, Fukunaga A, Yotsumoto K, Takata K, Tanaka T, Sakurai K, Iwashita H, Ueda S, Hirano G, Yokoyama K, Nakane H, Nishizawa S, Yoshikane M, Anan A, Takeyama Y, Kakumitsu S, Kitamura Y, Sakamoto M, Irie M, Shakado S, Sohda T, Watanabe H, Sakisaka S. Late-evening snack with branched-chain amino acids improves liver function after radiofrequency ablation for hepatocellular carcinoma. Hepatol Res. 2012 Jul;42(7):658-67. doi: 10.1111/j.1872-034X.2012.00969.x. Epub 2012 Mar 2. |
| 33207837 | Result | Tripodi F, Badone B, Vescovi M, Milanesi R, Nonnis S, Maffioli E, Bonanomi M, Gaglio D, Tedeschi G, Coccetti P. Methionine Supplementation Affects Metabolism and Reduces Tumor Aggressiveness in Liver Cancer Cells. Cells. 2020 Nov 16;9(11):2491. doi: 10.3390/cells9112491. |
| 21518402 | Result | Koreeda C, Seki T, Okazaki K, Ha-Kawa SK, Sawada S. Effects of late evening snack including branched-chain amino acid on the function of hepatic parenchymal cells in patients with liver cirrhosis. Hepatol Res. 2011 May;41(5):417-22. doi: 10.1111/j.1872-034X.2011.00795.x. |
| D008107 |
| Liver Diseases |