Qilu Hospital of Shandong University
Jinan, Shandong, 250012, China
NCT Number: NCT07488312
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.
Interested in participating?
Request Info18 year–70 year
All sexes
Interventional
Phase 1
Jinan, Shandong, 250012, China
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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
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
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.
Qilu Hospital of Shandong University
Other
A Study on the Safety of Leucine-Restricted Diet in Patients With Gastric Cancer
Acronym: LUCENT-GC-01
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