Effects of Parenteral and Enteral Nutrition on Skeletal Muscle Genomics

Not Applicable

Completed

• Conditions: Muscle Loss
• Interventions: Dietary Supplement: Enteral nutrition; Dietary Supplement: Parenteral nutrition (PN); Other: Control

• Registration Number: NCT05080816
• Lead Sponsor: Göteborg University

Brief Summary

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

Detailed Description

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.

Study Timeline

• Study Start: 2017-02-01
• Primary Completion: 2018-10-18
• Study Completion: 2018-10-18
• Study First Submitted: 2021-06-10
• Status Verified: 2021-10
• Study First Submitted QC: 2021-10-04
• Last Update Submitted: 2021-10-04
• Study First Posted: 2021-10-18
• Last Update Posted: 2021-10-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 39

Inclusion Criteria

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

Exclusion Criteria

• Insulin dependent diabetes.
• Steroid medication.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Enteral nutrition	Enteral nutrition	Oral nutrition drink. 2 \* 200 ml on the night before operation. 1\* 200 ml on the morning of operation day.
Parenteral nutrition	Parenteral nutrition (PN)	Overnight infusion of parenteral nutrition. Supplied as all-in-one-bag format. Infusion rate of 0.2 g N/kg/day.
control	Control	Overnight infusion of crystalloid fluid (Ringer acetate) infused at the same rate (ml/kg) as intervention PN

Primary Outcome Measures

Name	Time	Method
Muscle protein metabolism	~12-14 hours.	Alterations in skeletal muscle gene expression quantified by microarray

Trial Locations

Locations (1)

Sahlgrenska University Hospital; 🇸🇪 Gothenburg, Region Västra Götaland, Sweden