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By invitation only Phase 1 NCT07488312

Safety and Efficacy of Leucine-Restricted Diet in Gastric Cancer

Phase 1 – testing safety in a small group of people
Conditions: Gastric Cancer

Sponsor: Qilu Hospital of Shandong University

trial.available_in: БГ
Overview
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.
Who can participate
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.
Interventions
Leucine-restricted diet.
DIETARY_SUPPLEMENT
Locations 1
China (1)
Qilu Hospital of Shandong University
Jinan , Shandong
Technical details
Status
By invitation only
Phase
Phase 1
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
18 Years
Maximum age
70 Years
Healthy volunteers
No
Start date
01.10.2025
Completion date
01.12.2026
Registry ID
NCT07488312
Source
clinicaltrials.gov
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