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Effects of Parenteral and Enteral Nutrition on Skeletal Muscle Genomics

Sponsor
Göteborg University (Other)
Overall Status
Completed
CT.gov ID
NCT05080816
Collaborator
(none)
39
Enrollment
1
Location
3
Arms
20.5
Actual Duration (Months)
1.9
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Dietary Supplement: Parenteral nutrition (PN)
  • Dietary Supplement: Enteral nutrition
  • Other: Control
 N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
39 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Masking Description:
Persons responsible for genomic/transcriptomic/proteomics analyses are blinded. All samples are coded.
Primary Purpose:
Basic Science
Official Title:
Effects of Parenteral and Enteral Nutrition on Skeletal Muscle Genomics
Actual Study Start Date :
Feb 1, 2017
Actual Primary Completion Date :
Oct 18, 2018
Actual Study Completion Date :
Oct 18, 2018

Arms and Interventions

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

    Outcome Measures

    Primary Outcome Measures

    1. Muscle protein metabolism [~12-14 hours.]

      Alterations in skeletal muscle gene expression quantified by microarray

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 85 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Major gastrointestinal surgery.

    • Assumed need of post-operative nutrition support.

    Exclusion Criteria:

    • Insulin dependent diabetes.

    • Steroid medication.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Sahlgrenska University Hospital Gothenburg Region Västra Götaland Sweden 41345

    Sponsors and Collaborators

    • Göteborg University

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Göteborg University
    ClinicalTrials.gov Identifier:
    NCT05080816
    Other Study ID Numbers:
    • MB3
    First Posted:
    Oct 18, 2021
    Last Update Posted:
    Oct 18, 2021
    Last Verified:
    Oct 1, 2021
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Göteborg University
    Skeletal muscle

    Study Results

    No Results Posted as of Oct 18, 2021