Safety and Efficacy of Leucine-Restricted Diet in Gastric Cancer

NCT07488312 | Enrolling By Invitation Phase 1 DMC

• 1 other identifier: KYLL-2025-07-007-1
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 1

Brief Summary

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

Gastric Cancer

Keywords

Leucine-Restricted Diet; Gastric cancer

Outcome Measures

Primary Outcomes (2)

• Amino acid concentration

  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

  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 Outcomes (1)

• 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.

Study Arms (1)

Experimental Group

EXPERIMENTAL

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.

Interventions

Leucine-restricted diet. DIETARY_SUPPLEMENT

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.

Experimental Group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Qilu Hospital of Shandong University: lead

Study Sites (1)

Qilu Hospital of Shandong University

Jinan, Shandong, 250012, China

Location

Related Publications (15)

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MeSH Terms

Conditions

Stomach Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 17, 2026
• First Posted: March 23, 2026
• Study Start: October 1, 2025
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: April 20, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)