NCT06027242

Brief Summary

Glutamine has the potentials of immunomodulation and adjustment of protein metabolism. The primary objective of this study is to evaluate the efficacy of glutamine on sarcopenia in gastric adenocarcinoma patients undergoing gastrectomy. The secondary endpoints, including the physical activity, weight loss, and nutritional profiles, will be evaluated among these patients.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable gastric-cancer

Timeline
4mo left

Started Feb 2023

Typical duration for not_applicable gastric-cancer

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress91%
Feb 2023Aug 2026

Study Start

First participant enrolled

February 21, 2023

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

August 17, 2023

Completed
21 days until next milestone

First Posted

Study publicly available on registry

September 7, 2023

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2026

Last Updated

December 23, 2025

Status Verified

December 1, 2025

Enrollment Period

3.5 years

First QC Date

August 17, 2023

Last Update Submit

December 16, 2025

Conditions

Gastric CancerImmunonutritionGastrostomy

Keywords

Gastric cancerGastrectomysarcopenia

Outcome Measures

Primary Outcomes (1)

  • Change of area of psoas muscle

    area od psoas muscle on the CT scan

    84 days after gastrectomy

Secondary Outcomes (6)

  • Walking steps

    28,56, and 84 days after gastrectomy

  • body weight

    84 days after gastrectomy

  • Change of serum albumin value

    84 days after gastrectomy

  • Change in white blood cells counts

    84 days after gastrectomy

  • Change in lymphocyte cells counts

    84 days after gastrectomy

  • +1 more secondary outcomes

Study Arms (2)

Without oral glutamine supplementation

PLACEBO COMPARATOR

15 g Maltodextrin for 28 days after surgery with tolerable oral intake or enteral feeding

Dietary Supplement: Maltodextrin

With oral glutamine supplementation

ACTIVE COMPARATOR

10 g glutamine +5 g Maltodextrin for 28 days after surgery with tolerable oral intake or enteral feeding

Dietary Supplement: oral glutamineDietary Supplement: Maltodextrin

Interventions

oral glutamineDIETARY_SUPPLEMENT

10 g glutamine +5 g Maltodextrin for 28 days after surgery with tolerable oral intake or enteral feeding

With oral glutamine supplementation
MaltodextrinDIETARY_SUPPLEMENT

Maltodextrin

With oral glutamine supplementationWithout oral glutamine supplementation

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • adult gastric cancer receiving gastrectomy

You may not qualify if:

  • Hepatic insufficiency
  • Renal insufficiency
  • can not tolerate oral or enteral feeding 7 days after gastrectomy
  • can not receive computed tomograph
  • can not waer the wearable devices

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Taiwan University Hospital

Taipei, 100, Taiwan

RECRUITING

MeSH Terms

Conditions

Stomach NeoplasmsSarcopenia

Interventions

Glutaminemaltodextrin

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesStomach DiseasesMuscular AtrophyNeuromuscular ManifestationsNeurologic ManifestationsNervous System DiseasesAtrophyPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsSigns and Symptoms

Intervention Hierarchy (Ancestors)

Amino Acids, BasicAmino AcidsAmino Acids, Peptides, and ProteinsAmino Acids, DiaminoAmino Acids, Neutral

Study Officials

  • Jin-Ming Wu, MD

    National Taiwan University Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jin-Ming Wu, MD

CONTACT

886+223123456wujm0531@gmail.com

Ming-Tsan Lin, MD

CONTACT

wujm0531@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Jin-Ming Wu, Clinical Associate Professor & PhD

Study Record Dates

First Submitted

August 17, 2023

First Posted

September 7, 2023

Study Start

February 21, 2023

Primary Completion (Estimated)

August 30, 2026

Study Completion (Estimated)

August 30, 2026

Last Updated

December 23, 2025

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will not share

Locations

TW(1)