MyosteatosisPhase 2NCT07466758
Personalized Pharmaconutrition Therapy for Myosteatosis, Sarcopenia, and Prognosis in Gastric Cancer Patients
A Phase 2 study testing Pharmaconutrition in people with Myosteatosis and Sarcopenia, run by Biruni University at 2 sites in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years, men only
- Conditions the study is for
- Myosteatosis, Sarcopenia
- What is being tested?
- Pharmaconutrition
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 16 Oct 2024to 4 Mar 2026
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male adults aged between 18 and 64 years
- Diagnosed with primary or recurrent gastric cancer and eligible for surgery
- Body Mass Index (BMI) within the normal range (18.5-24.9 kg/m²)
- Capable of oral or enteral feeding
- Provided written informed consent
Who cannot join
- Absence of written informed consent
- Female sex
- Diagnosis of a benign tumor or a tumor located outside the stomach
- Not requiring surgical intervention
- Presence of renal failure or hepatic failure
- Presence of overt ascites or edema within the past month
- Prior use of the pharmaconutrition product planned for this study
Trial locations and contacts
2 sites in 1 country.
Turkey (Türkiye)2 sites
Basaksehir Cam and Sakura City Hospital
Istanbul
Istanbul Haseki Training and Research Hospital
Istanbul
About this study
Official title: The Effect of Personalised Pharmaconutrition Therapy on Myosteatosis, Sarcopenia and Prognosis in Patients With Gastric Cancer
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.
Read more
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
- Myosteatosis, Sarcopenia
- Being tested
- Pharmaconutrition
- Medical subject headings
- Sarcopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PharmaconutritionDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Personalised Pharmaconutrition Group | Experimental | Not described Receives: Drug: Pharmaconutrition |
| Control Group | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Skeletal Muscle Myosteatosis at the L3 Level Assessed by Computed Tomography
Myosteatosis will be assessed using computed tomography images at the L3 vertebral level. Skeletal muscle radiodensity (Hounsfield Units) will be used to evaluate myosteatosis. Changes between baseline and week 5 will be assessed in both the intervention and control groups.
Measured: Baseline and Postoperative week 4
Secondary outcomes (1)
Change in Skeletal Muscle Index (SMI)
Skeletal muscle index (SMI) will be calculated from skeletal muscle area measured on computed tomography images at the L3 vertebral level. SMI will be calculated as skeletal muscle area divided by height squared (cm²/m²). Changes between baseline and week 5 will be evaluated in both the intervention and control groups.
Measured: Baseline and Postoperative week 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2026
- Study start16 Oct 2024
- Primary completion4 Mar 2026
- Study completion4 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MyosteatosisStudies of the same condition, open and under way.
- More trials run by Biruni UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biruni University
- Sponsor type
- University, hospital or other
- Collaborators
- Halic University
- Responsible party
- Principal investigator, Ezgi ERTAL AKGÖZ, Biruni University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07466758
- Sponsor's protocol ID
- BİRUNİ-BAP-12-2025-01-51
- Status last verified
- Mar 2026
- First submitted
- 4 Mar 2026
- Last updated
- 12 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Personalised Pharmaconutrition Therapy on Myosteatosis, Sarcopenia and Prognosis in Patients With Gastric Cancer
- ClinicalTrials.gov ID
- NCT07466758
- Acronym / sponsor ID
- BİRUNİ-BAP-12-2025-01-51
- Conditions
- Myosteatosis, Sarcopenia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Biruni UniversityUniversity, hospital or other
- Collaborators
- Halic University
- Study start
- 16 Oct 2024 (actual)
- Primary completion
- 4 Mar 2026 (actual)
- Study completion
- 4 Mar 2026 (actual)
- First posted
- 12 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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?
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Personalised Pharmaconutrition Group | Experimental | Drug: Pharmaconutrition |
| Control Group | No intervention | – |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male adults aged between 18 and 64 years
- Diagnosed with primary or recurrent gastric cancer and eligible for surgery
- Body Mass Index (BMI) within the normal range (18.5-24.9 kg/m²)
- Capable of oral or enteral feeding
- Provided written informed consent
Key exclusion criteria (7 listed)
- Absence of written informed consent
- Female sex
- Diagnosis of a benign tumor or a tumor located outside the stomach
- Not requiring surgical intervention
- Presence of renal failure or hepatic failure
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PharmaconutritionThe 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. | Drug | Personalised Pharmaconutrition Group |
Primary outcome
Change in Skeletal Muscle Myosteatosis at the L3 Level Assessed by Computed Tomography
Time frame: Baseline and Postoperative week 4
Myosteatosis will be assessed using computed tomography images at the L3 vertebral level. Skeletal muscle radiodensity (Hounsfield Units) will be used to evaluate myosteatosis. Changes between baseline and week 5 will be assessed in both the intervention and control groups.
1 secondary outcome
Change in Skeletal Muscle Index (SMI)
Time frame: Baseline and Postoperative week 4
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Pharmaconutrition in people with Myosteatosis and Sarcopenia, run by Biruni University at 2 sites in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Skeletal Muscle Myosteatosis at the L3 Level Assessed by Computed Tomography (time frame: Baseline and Postoperative week 4). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Mar 2026.