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NCT05080816 Clinical Trial

Effects of Parenteral and Enteral Nutrition on Skeletal Muscle Genomics

Muscle Loss Clinical Trial

Official title:
Effects of Parenteral and Enteral Nutrition on Skeletal Muscle Genomics

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05080816
Other study ID # MB3
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date February 1, 2017
Est. completion date October 18, 2018

Study information
Verified date October 2021
Source Göteborg University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility
Status Completed
Enrollment 39
Est. completion date October 18, 2018
Est. primary completion date October 18, 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years to 85 Years
Eligibility Inclusion Criteria: - Major gastrointestinal surgery. - Assumed need of post-operative nutrition support. Exclusion Criteria: - Insulin dependent diabetes. - Steroid medication.

Study Design

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
Sweden Sahlgrenska University Hospital Gothenburg Region Västra Götaland

Sponsors (1)
Lead Sponsor Collaborator
Göteborg University

Country where clinical trial is conducted

Sweden, 

Outcome
Type Measure Description Time frame Safety issue
Primary Muscle protein metabolism Alterations in skeletal muscle gene expression quantified by microarray ~12-14 hours.
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