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Valine

Clinical trials investigating Valine are studying nutrition support in patients with serious illness or surgery. These studies look at outcomes such as muscle protein synthesis, muscle size, and infection risk. The target groups include chronic hemodialysis patients and people recovering from major abdominal surgery or oesophagectomy.

Table of contents

Trial overview

The clinical trials listed for Valine are studying nutrition support in patients with serious medical conditions and recovery needs.[1][2][3] All three studies are interventional, which means the researchers are giving a treatment and watching what happens.[1][2][3] Each trial is in Phase 3 and is currently authorised.[1][2][3]

Hemodialysis and muscle protein turnover

The LOTUS trial (NCT 2025-522111-42-02) is studying chronic hemodialysis patients and the effect of intradiialytic parenteral nutrition (IDPN), which is nutrition given during dialysis.[1] The study aims to see whether IDPN changes muscle protein synthesis and to describe its hemodynamic effects, meaning its effects on blood flow and circulation.[1]

The main outcome is the difference in myofibrillar fractional synthetic rate, a measure of how fast new muscle protein is made, during one week of IDPN compared with control treatment.[1] The trial plans to enroll 20 participants.[1]

Nutrition route after oesophagectomy

The trial titled “Route of nutrition and muscle wasting after oesophagectomy” (NCT 2023-507649-27-00) is studying patients after oesophagectomy, which is surgery to remove part or all of the esophagus.[2] Researchers want to understand how the route of nutrition affects cachexia, a term for severe muscle and weight loss during illness.[2]

This study uses SmofKabiven emulsion for infusion and is measuring the mean difference in muscle size on CT scan from before the operation to 10 days after oesophagostomy, as listed in the source data.[2] The planned enrollment is 38 patients.[2]

Supplementary parenteral nutrition after emergency abdominal surgery

The trial “Early versus postponed supplementary parenteral nutrition after major emergency abdominal surgery” (NCT 2023-505378-14-00) is comparing two timing strategies for extra nutrition given through a vein after surgery.[3] The study includes patients recovering from major emergency abdominal surgery.[3]

The intervention uses SmofKabiven Perifer and SmofKabiven, both given by infusion.[3] The main outcome is whether early or delayed supplementary parenteral nutrition reduces infectious complications during the hospital stay.[3] The trial plans to enroll 342 participants.[3]

Main outcomes being measured

The trials focus on practical outcomes that matter in hospital care, such as muscle building, muscle loss, and infection risk.[1][2][3] In the hemodialysis study, the key outcome is muscle protein synthesis measured over one week.[1] In the oesophagectomy study, the key outcome is muscle size on CT scan over time.[2] In the abdominal surgery study, the key outcome is the rate of infections during admission.[3]

Who the trials are for

These studies are not for one single disease group.[1][2][3] One trial is for chronic hemodialysis patients, one is for patients after oesophagectomy, and one is for patients after major emergency abdominal surgery.[1][2][3] The source data does not give full eligibility rules, so the exact entry criteria are not listed here.[1][2][3]

Trial phase and status

All listed Valine trials are in Phase 3, which is a later stage of clinical testing.[1][2][3] The status of each study is Authorised, meaning the trial has been approved to proceed in the source registry data.[1][2][3]

Trial ID Phase Condition studied Status Enrollment
2025-522111-42-02 Phase 3 Muscle protein turnover, hemodialysis Authorised 20
2023-507649-27-00 Phase 3 Oesophagectomy Authorised 38
2023-505378-14-00 Phase 3 Major emergency abdominal surgery Authorised 342

FAQ

  • What are the Valine clinical trials studying? The trials are studying nutrition support in different hospital settings. They focus on muscle protein turnover, muscle wasting, and infection risk after major surgery.
  • Who can take part in these studies? The target groups include chronic hemodialysis patients and patients after oesophagectomy or major emergency abdominal surgery. Each trial has its own eligibility rules.
  • What phase are the Valine trials in? All of the listed studies are Phase 3 trials. This means they are testing the intervention in larger patient groups to measure effects and safety in real clinical care.
  • What results are the trials measuring? The trials measure outcomes such as myofibrillar fractional synthetic rate, muscle size on CT scan, and the rate of infectious complications during hospital admission.
  • Are these trials about the same condition? No. They cover different clinical situations, including hemodialysis, oesophagectomy, and emergency abdominal surgery. The common theme is nutrition support and recovery in patients at risk of muscle loss or complications.

Ongoing Clinical Trials on Valine

  • Study of Intradialytic Parenteral Nutrition for Muscle Protein Production in Patients on Long-term Hemodialysis Treatment

    Not yet recruiting

    1 1 1 1
    Investigated diseases:
    Investigated drugs:
    The Netherlands

  • Study on Nutrition Methods and Muscle Loss After Esophagectomy Using SmofKabiven and Drug Combination for Patients Recovering from Esophageal Surgery

    Not yet recruiting

    1 1 1 1
    Investigated diseases:
    Investigated drugs:
    Denmark

  • Study on Early vs. Delayed Supplementary Parenteral Nutrition with SmofKabiven for Patients After Major Emergency Abdominal Surgery

    Not recruiting

    1 1 1 1
    Investigated diseases:
    Investigated drugs:
    Denmark

Glossary

  • Interventional study: A study where researchers give a treatment or nutrition plan and compare the results with another group.
  • Phase 3: A later stage of testing in a larger group of patients to see how well a treatment works and to collect more safety information.
  • Hemodialysis: A treatment that cleans the blood when the kidneys do not work well enough.
  • Muscle protein turnover: The process of breaking down and building muscle protein. It helps show whether the body is keeping or losing muscle.
  • Myofibrillar fractional synthetic rate: A measure of how fast the body is making new muscle protein.
  • Cachexia: Severe weight and muscle loss that can happen with serious illness.
  • CT-scan: An imaging test that uses X-rays to create detailed pictures inside the body.
  • Parenteral nutrition: Nutrition given through a vein instead of by mouth or through the stomach.
  • Supplementary parenteral nutrition: Extra nutrition given through a vein when eating by mouth is not enough.
  • Infectious complications: Infections or infection-related problems that happen during a hospital stay.

References

  1. https://clinicaltrials.gov/study/2025-522111-42-02
  2. https://clinicaltrials.gov/study/2023-507649-27-00
  3. https://clinicaltrials.gov/study/2023-505378-14-00