Enteral Nutrition Regimen Prior to SurgeryNCT00662376
Study on Safety, Tolerance and Metabolic Effects of a Nutritional Supplement, Given as a Drink Before Gallbladder Surgery
A study testing PreOP Booster (oral nutritional supplement, food for special medical purposes) in people with Enteral Nutrition Regimen Prior to Surgery, run by Fresenius Kabi at 1 site in United Kingdom.
Trial summary
The aim of this pilot study is to obtain data on the safety, tolerance and metabolic effects of the oral nutritional supplement (PreOP Booster) given to patients prior to gastrointestinal surgery. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Enteral Nutrition Regimen Prior to Surgery
- What is being tested?
- PreOP Booster (oral nutritional supplement, food for special medical purposes)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Apr 2008to Oct 2008
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- elective laparoscopic cholecystectomy
Who cannot join
- bile duct stones
- ileus
- conditions affecting gastric emptying
- severe, organ-specific disorders
- HIV
- inherited metabolic disorders
- known intolerance against or allergy to any component of the investigational feeds
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Queen's Medical Centre, Division of Gastrointestinal Surgery, Nottingham University Hospitals;
Nottingham
About this study
Official title: Safety, Tolerance and Metabolic Effects of Using a Preoperative Oral Nutritional Supplement (PreOP Booster) in Gastrointestinal Surgery
The aim of this pilot study is to obtain data on the safety, tolerance and metabolic effects of the oral nutritional supplement (PreOP Booster) given to patients prior to gastrointestinal surgery.
- Being tested
- PreOP Booster (oral nutritional supplement, food for special medical purposes)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PreOP Booster (oral nutritional supplement, food for special medical purposes)Dietary supplement
3 x 1 dosages of oral nutritional supplement / placebo are given prior to surgery: 2 the evening before the day of operation and 1 dosage 3-4 h before initiation of anaesthesia
| Study group | Role | What they receive |
|---|---|---|
| Test | Experimental | oral nutritional supplement (assignment: according to consecutive random numbers) Receives: Dietary Supplement: PreOP Booster (oral nutritional supplement, food for special medical purposes) |
| Control | Placebo comparator | placebo (assignment: according to consecutive random numbers) Receives: Dietary Supplement: PreOP Booster (oral nutritional supplement, food for special medical purposes) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety parameters reflecting pathophysiological functions of the liver
Measured: day -1, 0, 1, and 7
Gastrointestinal tolerance
Measured: day 0 before and 6-8h after surgery
Metabolic parameters in serum, liver and muscle tissue
Measured: on day -1, 0, 1, and 7
Secondary outcomes (1)
Clinical parameters (infectious and non-infectious complications)
Measured: until day 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2008 (estimated)
- Study startApr 2008
- Primary completionOct 2008
- Study completionOct 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Enteral Nutrition Regimen Prior to SurgeryStudies of the same condition, open and under way.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fresenius Kabi
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Dileep N. Lobo, MS, DM, FRCS, Principal investigator, Queen's Medical Centre, Division of Gastrointestinal Surgery, Nottingham University Hospitals;
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00662376
- Sponsor's protocol ID
- N-POB-01-UK
- Status last verified
- Nov 2008
- First submitted
- 17 Apr 2008
- Last updated
- 8 Dec 2008
- Results posted
- No
Publications
Awad S, Stephens F, Shannon C, Lobo DN. Perioperative perturbations in carnitine metabolism are attenuated by preoperative carbohydrate treatment: Another mechanism by which preoperative feeding may attenuate development of postoperative insulin resistance. Clin Nutr. 2012 Oct;31(5):717-20. doi: 10.1016/j.clnu.2012.02.015. Epub 2012 Mar 22.
PubMed 22444237Awad S, Constantin-Teodosiu D, Constantin D, Rowlands BJ, Fearon KC, Macdonald IA, Lobo DN. Cellular mechanisms underlying the protective effects of preoperative feeding: a randomized study investigating muscle and liver glycogen content, mitochondrial function, gene and protein expression. Ann Surg. 2010 Aug;252(2):247-53. doi: 10.1097/SLA.0b013e3181e8fbe6.
PubMed 20622656
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety, Tolerance and Metabolic Effects of Using a Preoperative Oral Nutritional Supplement (PreOP Booster) in Gastrointestinal Surgery
- ClinicalTrials.gov ID
- NCT00662376
- Acronym / sponsor ID
- N-POB-01-UK
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Fresenius KabiIndustry (pharma, biotech, devices)
- Study start
- Apr 2008
- Primary completion
- Oct 2008 (actual)
- Study completion
- Oct 2008 (actual)
- First posted
- 21 Apr 2008 (estimated)
- 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 aim of this pilot study is to obtain data on the safety, tolerance and metabolic effects of the oral nutritional supplement (PreOP Booster) given to patients prior to gastrointestinal surgery.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Test | Experimental | Dietary Supplement: PreOP Booster (oral nutritional supplement, food for special medical purposes)oral nutritional supplement (assignment: according to consecutive random numbers) |
| Control | Placebo comparator | Dietary Supplement: PreOP Booster (oral nutritional supplement, food for special medical purposes)placebo (assignment: according to consecutive random numbers) |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- elective laparoscopic cholecystectomy
Key exclusion criteria (7 listed)
- bile duct stones
- ileus
- conditions affecting gastric emptying
- severe, organ-specific disorders
- HIV
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 |
|---|---|---|
| PreOP Booster (oral nutritional supplement, food for special medical purposes)3 x 1 dosages of oral nutritional supplement / placebo are given prior to surgery: 2 the evening before the day of operation and 1 dosage 3-4 h before initiation of anaesthesia | Dietary supplement | Control, Test |
Primary outcome
Safety parameters reflecting pathophysiological functions of the liver
Time frame: day -1, 0, 1, and 7
Gastrointestinal tolerance
Time frame: day 0 before and 6-8h after surgery
Metabolic parameters in serum, liver and muscle tissue
Time frame: on day -1, 0, 1, and 7
1 secondary outcome
Clinical parameters (infectious and non-infectious complications)
Time frame: until day 7
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 8 Dec 2008.
- Derived from this study: PubMed 22444237Awad S, Stephens F, Shannon C, Lobo DN. Perioperative perturbations in carnitine metabolism are attenuated by preoperative carbohydrate treatment: Another mechanism by which preoperative feeding may attenuate development of postoperative insulin resistance. Clin Nutr. 2012 Oct;31(5):717-20. doi: 10.1016/j.clnu.2012.02.015. Epub 2012 Mar 22.
- Derived from this study: PubMed 20622656Awad S, Constantin-Teodosiu D, Constantin D, Rowlands BJ, Fearon KC, Macdonald IA, Lobo DN. Cellular mechanisms underlying the protective effects of preoperative feeding: a randomized study investigating muscle and liver glycogen content, mitochondrial function, gene and protein expression. Ann Surg. 2010 Aug;252(2):247-53. doi: 10.1097/SLA.0b013e3181e8fbe6.
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.
Dileep N. Lobo, MS, DM, FRCS principal investigator
Queen's Medical Centre, Division of Gastrointestinal Surgery, Nottingham University Hospitals;
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PreOP Booster (oral nutritional supplement, food for special medical purposes) in people with Enteral Nutrition Regimen Prior to Surgery, run by Fresenius Kabi at 1 site in United Kingdom.
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 1 inclusion and 7 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 8 Dec 2008. 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 United Kingdom. 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?
Safety parameters reflecting pathophysiological functions of the liver (time frame: day -1, 0, 1, and 7). The study lists 3 primary outcomes in all. 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 NCT00662376, which also lists 2 linked publications.
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 8 Dec 2008.