Clinical trial · Interventional
Safety and Efficacy of Leucine-Restricted Diet in Gastric Cancer
A Study on the Safety of Leucine-Restricted Diet in Patients With Gastric Cancer
NCT07488312CI-TRIAL-00108805LUCENT-GC-01enrolling by invitationPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The primary objectives of this study is o evaluate the safety of a leucine-restricted diet in patients with gastric cancer and determine the impact of a leucine-restricted diet on serum amino acid concentrations in patients with gastric cancer.Besides,we can assess changes in the immune microenvironment of gastric cancer patients following administration of a leucine-restricted diet and observe alterations in body composition of gastric cancer patients after the application of a leucine-restricted diet.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Gastric Cancer | Malignant Gastric Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Leucine-restricted diet. | Dietary Supplement | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Experimental Group
- description
- During the preoperative waiting period after hospital admission, study participants received a leucine-restricted diet for three days prior to surgery. Surgical intervention was performed immediately following the 3-day dietary intervention. Postoperatively, patients gradually resumed a regular diet according to standard surgical protocols.
- interventionNames
- Dietary Supplement: Leucine-restricted diet.
Primary outcomes (2)
- measure
- Amino acid concentration
- timeFrame
- Measurements were performed prior to the initiation of the amino acid-restricted diet and on the day of surgery before the operation
- description
- Following leucine-restricted diet intervention, peripheral venous blood was collected from gastric cancer patients to measure serum concentrations of various amino acids, including leucine
- measure
- The adverse event of leucine-restricted diet in patients with gastric cancer
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: * Pathologically confirmed gastric carcinoma requiring preoperative endoscopic localization marking or delineation of the lesion extent. * Aged between 18 and 70 years, regardless of gender. * Ability to consume oral or nasogastric tube feeding of a liquid diet. * Provision of signed informed consent and voluntary participation in this study. * No evidence of distant metastasis on preoperative imaging studies (e.g., CT, PET-CT), and deemed suitable for surgical resection. * No concurrent diagnosis of other active malignancies. Exclusion Criteria: * Presence of cognitive impairment or psychological disorders that may compromise the understanding of the research content. * Diagnosis of Type I or Type II Diabetes Mellitus. * Severe diarrhea, intractable vomiting, severe malabsorption syndromes, paralytic or mechanical intestinal obstruction, or active gastrointestinal bleeding. * Known allergy to the primary components of the leucine-deficient nutritional formula. * Concurrent use of other nutritional supplements that may interfere with the trial's efficacy. * Postoperative pathological diagnosis confirming non-primary gastric cancer.
References
Publications (15)
- BACKGROUNDLordick F, Carneiro F, Cascinu S, Fleitas T, Haustermans K, Piessen G, Vogel A, Smyth EC; ESMO Guidelines Committee. Electronic address: clinicalguidelines@esmo.org. Gastric cancer: ESMO Clinical Practice Guideline for diagnosis, treatment and follow-up. Ann Oncol. 2022 Oct;33(10):1005-1020. doi: 10.1016/j.annonc.2022.07.004. Epub 2022 Jul 29. No abstract available. PMID 35914639
- BACKGROUNDMuscaritoli M, Arends J, Bachmann P, Baracos V, Barthelemy N, Bertz H, Bozzetti F, Hutterer E, Isenring E, Kaasa S, Krznaric Z, Laird B, Larsson M, Laviano A, Muhlebach S, Oldervoll L, Ravasco P, Solheim TS, Strasser F, de van der Schueren M, Preiser JC, Bischoff SC. ESPEN practical guideline: Clinical Nutrition in cancer. Clin Nutr. 2021 May;40(5):2898-2913. doi: 10.1016/j.clnu.2021.02.005. Epub 2021 Mar 15. PMID 33946039
- BACKGROUNDPowell JD, Pollizzi KN, Heikamp EB, Horton MR. Regulation of immune responses by mTOR. Annu Rev Immunol. 2012;30:39-68. doi: 10.1146/annurev-immunol-020711-075024. Epub 2011 Nov 29. PMID 22136167
- BACKGROUNDDelgoffe GM, Powell JD. mTOR: taking cues from the immune microenvironment. Immunology. 2009 Aug;127(4):459-65. doi: 10.1111/j.1365-2567.2009.03125.x. PMID 19604300
- BACKGROUNDAraki K, Ellebedy AH, Ahmed R. TOR in the immune system. Curr Opin Cell Biol. 2011 Dec;23(6):707-15. doi: 10.1016/j.ceb.2011.08.006. Epub 2011 Sep 16. PMID 21925855
- BACKGROUNDPassarelli MC, Pinzaru AM, Asgharian H, Liberti MV, Heissel S, Molina H, Goodarzi H, Tavazoie SF. Leucyl-tRNA synthetase is a tumour suppressor in breast cancer and regulates codon-dependent translation dynamics. Nat Cell Biol. 2022 Mar;24(3):307-315. doi: 10.1038/s41556-022-00856-5. Epub 2022 Mar 14. PMID 35288656
- BACKGROUNDSaito Y, Li L, Coyaud E, Luna A, Sander C, Raught B, Asara JM, Brown M, Muthuswamy SK. LLGL2 rescues nutrient stress by promoting leucine uptake in ER+ breast cancer. Nature. 2019 May;569(7755):275-279. doi: 10.1038/s41586-019-1126-2. Epub 2019 Apr 17.