Study on Safety, Tolerance and Metabolic Effects of a Nutritional Supplement, Given as a Drink Before Gallbladder Surgery
NCT ID: NCT00662376
Last Updated: 2008-12-08
Study Results
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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COMPLETED
NA
40 participants
INTERVENTIONAL
2008-04-30
2008-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
DOUBLE
Study Groups
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Test
oral nutritional supplement (assignment: according to consecutive random numbers)
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
Control
placebo (assignment: according to consecutive random numbers)
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
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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
18 Years
80 Years
ALL
No
Sponsors
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Fresenius Kabi
INDUSTRY
Responsible Party
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Kabi Innovation Centre, Fresenius Kabi Deutschland GmbH
Principal Investigators
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Dileep N. Lobo, MS, DM, FRCS
Role: PRINCIPAL_INVESTIGATOR
Queen's Medical Centre, Division of Gastrointestinal Surgery, Nottingham University Hospitals;
Locations
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Queen's Medical Centre, Division of Gastrointestinal Surgery, Nottingham University Hospitals;
Nottingham, , United Kingdom
Countries
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References
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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.
Awad 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.
Other Identifiers
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N-POB-01-UK
Identifier Type: -
Identifier Source: org_study_id