Effects of Parenteral and Enteral Nutrition on Skeletal Muscle Genomics

October 4, 2021 updated by: Göteborg University
The study investigates effects related to muscle protein metabolism at provision of Parenteral or enteral nutrition

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

39

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
    • Region Västra Götaland
      • Gothenburg, Region Västra Götaland, Sweden, 41345
        • Sahlgrenska University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • Insulin dependent diabetes.
  • Steroid medication.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Parenteral nutrition
Overnight infusion of parenteral nutrition. Supplied as all-in-one-bag format. Infusion rate of 0.2 g N/kg/day.
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.
Other Names:
  • Total parenteral nutrition (TPN)
Active Comparator: Enteral nutrition
Oral nutrition drink. 2 * 200 ml on the night before operation. 1* 200 ml on the morning of operation day.
Dietary supplement: Enteral nutrition
Oral nutrition drink. 2 * 200 ml on the night before operation. 1* 200 ml on the morning of operation day.
Other Names:
  • nutrition drink
Placebo Comparator: control
Overnight infusion of crystalloid fluid (Ringer acetate) infused at the same rate (ml/kg) as intervention PN
Other: Control
Overnight infusion of crystalloid fluid (Ringer acetate) infused at the same rate (ml/kg) as intervention PN

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Muscle protein metabolism
Time Frame: ~12-14 hours.
Alterations in skeletal muscle gene expression quantified by microarray
~12-14 hours.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Göteborg University

Investigators

  • Principal Investigator: Britt-Marie Iresjö, Ph.D, Göteborg University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2017

Primary Completion (Actual)

October 18, 2018

Study Completion (Actual)

October 18, 2018

Study Registration Dates

First Submitted

June 10, 2021

First Submitted That Met QC Criteria

October 4, 2021

First Posted (Actual)

October 18, 2021

Study Record Updates

Last Update Posted (Actual)

October 18, 2021

Last Update Submitted That Met QC Criteria

October 4, 2021

Last Verified

October 1, 2021

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • MB3

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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