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Effects of Parenteral and Enteral Nutrition on Skeletal Muscle Genomics

NCT ID: NCT05080816

Last Updated: 2021-10-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

39 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-02-01

Study Completion Date

2018-10-18

Brief Summary

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

Detailed Description

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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.

Conditions

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Muscle Loss

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

SINGLE

Outcome Assessors
Persons responsible for genomic/transcriptomic/proteomics analyses are blinded. All samples are coded.

Study Groups

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Parenteral nutrition

Overnight infusion of parenteral nutrition. Supplied as all-in-one-bag format. Infusion rate of 0.2 g N/kg/day.

Group Type ACTIVE_COMPARATOR

Parenteral nutrition (PN)

Intervention Type DIETARY_SUPPLEMENT

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.

Group Type ACTIVE_COMPARATOR

Enteral nutrition

Intervention Type DIETARY_SUPPLEMENT

Oral nutrition drink. 2 \* 200 ml on the night before operation. 1\* 200 ml on the morning of operation day.

control

Overnight infusion of crystalloid fluid (Ringer acetate) infused at the same rate (ml/kg) as intervention PN

Group Type PLACEBO_COMPARATOR

Control

Intervention Type OTHER

Overnight infusion of crystalloid fluid (Ringer acetate) infused at the same rate (ml/kg) as intervention PN

Interventions

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Parenteral nutrition (PN)

Overnight infusion of parenteral nutrition. Supplied as all-in-one-bag format. Infusion rate of 0.2 g N/kg/day.

Intervention Type DIETARY_SUPPLEMENT

Enteral nutrition

Oral nutrition drink. 2 \* 200 ml on the night before operation. 1\* 200 ml on the morning of operation day.

Intervention Type DIETARY_SUPPLEMENT

Control

Overnight infusion of crystalloid fluid (Ringer acetate) infused at the same rate (ml/kg) as intervention PN

Intervention Type OTHER

Other Intervention Names

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Total parenteral nutrition (TPN) nutrition drink

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* Insulin dependent diabetes.
* Steroid medication.
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Göteborg University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Britt-Marie Iresjö, Ph.D

Role: PRINCIPAL_INVESTIGATOR

Göteborg University

Locations

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Sahlgrenska University Hospital

Gothenburg, Region Västra Götaland, Sweden

Site Status

Countries

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Sweden

References

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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.

Reference Type DERIVED
PMID: 39039509 (View on PubMed)

Other Identifiers

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MB3

Identifier Type: -

Identifier Source: org_study_id