NCT07488312Enrolling by invitationPhase 1
Safety and Efficacy of Leucine-Restricted Diet in Gastric Cancer
A Study on the Safety of Leucine-Restricted Diet in Patients With Gastric Cancer
Source: ClinicalTrials.gov · Last updated 20 Apr 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Enrolling by invitation
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 37 (estimated)
- First submitted
- 17 Mar 2026
- Start date
- Oct 2025
- Primary completion date
- Oct 2026
- Lead sponsor
- Qilu Hospital of Shandong University
- Diseases
- Gastric and esophageal cancer
- NCT number
- NCT07488312
What you commit to
- Study type: Interventional · Phase 1
- Planned participants: 37
- From Oct 2025 to the primary completion date, Oct 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Concurrent use of other nutritional supplements that may interfere with the trial's efficacy.
Other illness
- 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.
- Postoperative pathological diagnosis confirming non-primary gastric cancer.
Who the study is looking for
- 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.
Age in the registry: 18 years to 70 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Qilu Hospital of Shandong University Coordinator of this site? Confirm its status | Jinan | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.