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Personalized Pharmaconutrition Therapy for Myosteatosis, Sarcopenia, and Prognosis in Gastric Cancer Patients

NCT07466758 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2026-03-12

No results posted yet for this study

Summary

This randomized controlled trial aims to evaluate the effect of personalized pharmaconutrition therapy on myosteatosis, sarcopenia, and disease prognosis in patients undergoing surgery due to gastric cancer. Myosteatosis refers to the accumulation of fat within skeletal muscle and is an important indicator of muscle quality and may be associated with postoperative recovery and disease outcomes.

A total of 40 patients will be included in the study (20 controls, 20 intervention). In addition to standard nutritional care, the intervention group will receive an amino acid-based pharmaconutrition protocol containing glutamine, arginine, and beta-hydroxy-beta-methylbutyrate. The pharmaconutritional intervention will be dosed according to individual requirements so that the total protein intake from the diet is 1-1.5 g/kg, based on the analysis of weekly food consumption records taken from the start to the end of the study. The control group will receive only standard nutritional care.

Myosteatosis, an indicator of muscle quality, will be assessed using computed tomography (CT) images obtained at the level of the third lumbar vertebra (L3). For the evaluation of myosteatosis, the mean radiodensity of skeletal muscle within the range of -29 to +150 Hounsfield Units (HU) will be used. Sarcopenia will be determined using the skeletal muscle index (SMI), which is calculated by dividing skeletal muscle area (SMA) by the square of height (cm²/m²). In addition, clinical and nutritional parameters will also be evaluated.

Measurements will be performed at one week before surgery and at postoperative week 4. Disease prognosis will be evaluated using the Glasgow Prognostic Score and the Prognostic Nutritional Index. The aim of this study is to determine the effects of personalized pharmaconutrition therapy on myosteatosis, sarcopenia, disease prognosis, and clinical outcomes in patients with gastric cancer.

Research Question: Does personalized pharmaconutrition therapy affect myosteatosis and sarcopenia in patients undergoing gastric cancer surgery?

Conditions

Interventions

DRUG

Pharmaconutrition

The intervention includes a personalised pharmaconutrition formula containing arginine, glutamine, and beta-hydroxy-beta-methylbutyrate (HMB). It is administered orally as a powder dissolved in water. The intervention is applied for one week before surgery and four weeks after surgery. The dosage is individually adjusted every week based on retrospective 24-hour dietary recall data to ensure total daily protein intake reaches 1.0-1.5 g/kg/day. The product is used as a dietary supplement and does not replace meals.

Sponsors & Collaborators

  • Halic University

    collaborator OTHER

  • Biruni University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-10-16
Primary Completion
2026-03-04
Completion
2026-03-04

Countries

  • Turkey (Türkiye)

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07466758 on ClinicalTrials.gov