Safety and Efficacy of Leucine-Restricted Diet in Gastric Cancer (LUCENT-GC-01)

April 15, 2026 updated by: Qilu Hospital of Shandong University

A Study on the Safety of Leucine-Restricted Diet in Patients With Gastric Cancer

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.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

37

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Shandong
      • Jinan, Shandong, China, 250012
        • Qilu Hospital of Shandong University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental Group
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.
Dietary supplement: Leucine-restricted diet.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Amino acid concentration
Time Frame: Measurements were performed prior to the initiation of the amino acid-restricted diet and on the day of surgery before the operation
Following leucine-restricted diet intervention, peripheral venous blood was collected from gastric cancer patients to measure serum concentrations of various amino acids, including leucine
Measurements were performed prior to the initiation of the amino acid-restricted diet and on the day of surgery before the operation
The adverse event of leucine-restricted diet in patients with gastric cancer
Time Frame: 6 months after surgery
This indicator was assessed using the Common Terminology Criteria for Adverse Event(CTCAE) grading system, which comprises five grades (1-5). Grade 1 represents no or mild symptoms, while Grade 5 indicates death
6 months after surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
CD8+ T cell percentage
Time Frame: Measurements were performed prior to the initiation of the amino acid-restricted diet and on the day of surgery before the operation.
Following leucine-restricted diet intervention, peripheral venous blood was collected from gastric cancer patients to measure serum concentrations of CD8+ T cell percentage.
Measurements were performed prior to the initiation of the amino acid-restricted diet and on the day of surgery before the operation.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Qilu Hospital of Shandong University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2025

Primary Completion (Estimated)

October 1, 2026

Study Completion (Estimated)

December 1, 2026

Study Registration Dates

First Submitted

March 17, 2026

First Submitted That Met QC Criteria

March 17, 2026

First Posted (Actual)

March 23, 2026

Study Record Updates

Last Update Posted (Actual)

April 20, 2026

Last Update Submitted That Met QC Criteria

April 15, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KYLL-2025-07-007-1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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