Muscle LossNCT05080816
Effects of Parenteral and Enteral Nutrition on Skeletal Muscle Genomics
A study testing Parenteral nutrition (PN) and Enteral nutrition in people with Muscle Loss, run by Göteborg University at 1 site in Sweden.
Trial summary
The study investigates effects related to muscle protein metabolism at provision of Parenteral or enteral nutrition Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Muscle Loss
- What is being tested?
- Parenteral nutrition (PN) and Enteral nutrition
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 39 participants
- Where
- 1 siteSweden
- Study dates
- 1 Feb 2017to 18 Oct 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Major gastrointestinal surgery.
- Assumed need of post-operative nutrition support.
Who cannot join
- Insulin dependent diabetes.
- Steroid medication.
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Sahlgrenska University Hospital
Gothenburg, Region Västra Götaland, 41345
About this study
The study investigates effects related to muscle protein metabolism at provision of Parenteral or enteral nutrition
Read the 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.
- Conditions
- Muscle Loss
- Being tested
- Parenteral nutrition (PN), Enteral nutrition, Control
- Keywords
- Skeletal muscle
- Medical subject headings
- Muscular Atrophy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Parenteral nutrition (PN)Dietary supplement
Also called Total parenteral nutrition (TPN)
Overnight infusion of parenteral nutrition. Supplied as all-in-one-bag format. Infusion rate of 0.2 g N/kg/day.
Enteral nutritionDietary supplement
Also called nutrition drink
Oral nutrition drink. 2 * 200 ml on the night before operation. 1* 200 ml on the morning of operation day.
ControlOther
Overnight infusion of crystalloid fluid (Ringer acetate) infused at the same rate (ml/kg) as intervention PN
| Study group | Role | What they receive |
|---|---|---|
| Parenteral nutrition | Active comparator | Overnight infusion of parenteral nutrition. Supplied as all-in-one-bag format. Infusion rate of 0.2 g N/kg/day. Receives: Dietary Supplement: Parenteral nutrition (PN) |
| Enteral nutrition | Active comparator | Oral nutrition drink. 2 * 200 ml on the night before operation. 1* 200 ml on the morning of operation day. Receives: Dietary Supplement: Enteral nutrition |
| control | Placebo comparator | Overnight infusion of crystalloid fluid (Ringer acetate) infused at the same rate (ml/kg) as intervention PN Receives: Other: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Muscle protein metabolism
Alterations in skeletal muscle gene expression quantified by microarray
Measured: ~12-14 hours.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2021
- Study start1 Feb 2017
- Primary completion18 Oct 2018
- Study completion18 Oct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Muscle LossStudies of the same condition, open and under way.
- More trials run by Göteborg UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- Göteborg University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Britt-Marie Iresjö, Ph.D, Principal investigator, Göteborg University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05080816
- Sponsor's protocol ID
- MB3
- Status last verified
- Oct 2021
- First submitted
- 10 Jun 2021
- Last updated
- 18 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 39039509
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Parenteral and Enteral Nutrition on Skeletal Muscle Genomics
- ClinicalTrials.gov ID
- NCT05080816
- Acronym / sponsor ID
- MB3
- Conditions
- Muscle Loss
- Keywords
- Skeletal muscle
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- Göteborg UniversityUniversity, hospital or other
- Study start
- 1 Feb 2017 (actual)
- Primary completion
- 18 Oct 2018 (actual)
- Study completion
- 18 Oct 2018 (actual)
- First posted
- 18 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study investigates effects related to muscle protein metabolism at provision of Parenteral or enteral nutrition
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
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Parenteral nutrition | Active comparator | 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 | Active comparator | Dietary Supplement: Enteral nutritionOral nutrition drink. 2 * 200 ml on the night before operation. 1* 200 ml on the morning of operation day. |
| control | Placebo comparator | Other: ControlOvernight infusion of crystalloid fluid (Ringer acetate) infused at the same rate (ml/kg) as intervention PN |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Major gastrointestinal surgery.
- Assumed need of post-operative nutrition support.
Key exclusion criteria (2 listed)
- Insulin dependent diabetes.
- Steroid medication.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Parenteral nutrition (PN)Also: Total parenteral nutrition (TPN)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 |
| Enteral nutritionAlso: nutrition drinkOral nutrition drink. 2 * 200 ml on the night before operation. 1* 200 ml on the morning of operation day. | Dietary supplement | Enteral nutrition |
| ControlOvernight infusion of crystalloid fluid (Ringer acetate) infused at the same rate (ml/kg) as intervention PN | Other | control |
Primary outcome
Muscle protein metabolism
Time frame: ~12-14 hours.
Alterations in skeletal muscle gene expression quantified by microarray
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Oct 2021.
- Derived from this study: PubMed 39039509Iresjo 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Britt-Marie Iresjö, Ph.D principal investigator
Göteborg University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Parenteral nutrition (PN) and Enteral nutrition in people with Muscle Loss, run by Göteborg University at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Muscle protein metabolism (time frame: ~12-14 hours.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05080816, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Oct 2021.