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Enrolling by Invitation

NCT Number: NCT07488312

Safety and Efficacy of Leucine-Restricted Diet in 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.

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Qilu Hospital of Shandong University

Jinan, Shandong, 250012, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. 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

  2. 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

Secondary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Qilu Hospital of Shandong University

Other

Registry information

Official study title

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

Acronym: LUCENT-GC-01

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Mar 23, 2026
Registry last updated
Apr 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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