Effects of Parenteral and Enteral Nutrition on Skeletal Muscle Genomics
1 other identifier
interventional
39
1 country
1
Brief Summary
The study investigates effects related to muscle protein metabolism at provision of Parenteral or enteral nutrition
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Feb 2017
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 18, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
October 18, 2018
CompletedFirst Submitted
Initial submission to the registry
June 10, 2021
CompletedFirst Posted
Study publicly available on registry
October 18, 2021
CompletedOctober 18, 2021
October 1, 2021
1.7 years
June 10, 2021
October 4, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Muscle protein metabolism
Alterations in skeletal muscle gene expression quantified by microarray
~12-14 hours.
Study Arms (3)
Parenteral nutrition
ACTIVE COMPARATOROvernight infusion of parenteral nutrition. Supplied as all-in-one-bag format. Infusion rate of 0.2 g N/kg/day.
Enteral nutrition
ACTIVE COMPARATOROral nutrition drink. 2 \* 200 ml on the night before operation. 1\* 200 ml on the morning of operation day.
control
PLACEBO COMPARATOROvernight infusion of crystalloid fluid (Ringer acetate) infused at the same rate (ml/kg) as intervention PN
Interventions
Overnight infusion of parenteral nutrition. Supplied as all-in-one-bag format. Infusion rate of 0.2 g N/kg/day.
Oral nutrition drink. 2 \* 200 ml on the night before operation. 1\* 200 ml on the morning of operation day.
Overnight infusion of crystalloid fluid (Ringer acetate) infused at the same rate (ml/kg) as intervention PN
Eligibility Criteria
You may qualify if:
- Major gastrointestinal surgery.
- Assumed need of post-operative nutrition support.
You may not qualify if:
- Insulin dependent diabetes.
- Steroid medication.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Sahlgrenska University Hospital
Gothenburg, Region Västra Götaland, 41345, Sweden
Related Publications (1)
Iresjo BM, Smedh U, Engstrom C, Persson J, Martensson C, Lundholm K. A randomized translational study on protein- and glucose metabolism in skeletal muscles evaluated by gene-ontology, following preoperative oral carbohydrate loading compared to overnight peripheral parenteral nutrition (PPN) before major cancer surgery. J Transl Med. 2024 Jul 22;22(1):675. doi: 10.1186/s12967-024-05484-1.
PMID: 39039509DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Britt-Marie Iresjö, Ph.D
Göteborg University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Masking Details
- Persons responsible for genomic/transcriptomic/proteomics analyses are blinded. All samples are coded.
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 10, 2021
First Posted
October 18, 2021
Study Start
February 1, 2017
Primary Completion
October 18, 2018
Study Completion
October 18, 2018
Last Updated
October 18, 2021
Record last verified: 2021-10