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Completed

NCT Number: NCT05080816

Effects of Parenteral and Enteral Nutrition on Skeletal Muscle Genomics

The study investigates effects related to muscle protein metabolism at provision of Parenteral or enteral nutrition

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Key information

Conditions

Muscle Loss Atrophy Muscular Atrophy Nervous System Diseases Neurologic Manifestations Neuromuscular Manifestations Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sahlgrenska University Hospital

Gothenburg, Region Västra Götaland, 41345, Sweden

About this study

Randomized study investigation alterations in muscle protein metabolism at provision of parenteral or enteral (oral drink) nutrition. The study uses a genomic/transcriptomic/proteomic approach to evaluate factors related to activation of skeletal muscle protein synthesis and protein degradation. Patients scheduled for major gastrointestinal surgery are included. Muscle specimens are collected during surgery.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Major gastrointestinal surgery.
  • Assumed need of post-operative nutrition support.

Exclusion criteria

  • Insulin dependent diabetes.
  • Steroid medication.

Treatment and study plan

Parenteral nutrition (PN)

Dietary Supplement

Overnight infusion of parenteral nutrition. Supplied as all-in-one-bag format. Infusion rate of 0.2 g N/kg/day.

Other names: Total parenteral nutrition (TPN)

Enteral Nutrition

Dietary Supplement

Oral nutrition drink. 2 * 200 ml on the night before operation. 1* 200 ml on the morning of operation day.

Other names: nutrition drink

Control

Other

Overnight infusion of crystalloid fluid (Ringer acetate) infused at the same rate (ml/kg) as intervention PN

Primary outcomes

  1. Muscle protein metabolism

    Time frame: ~12-14 hours.

    Alterations in skeletal muscle gene expression quantified by microarray

Sponsors and collaborators

Lead sponsor

Göteborg University

Other

Registry information

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Oct 18, 2021
Registry last updated
Oct 18, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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