Study on Safety, Tolerance and Metabolic Effects of a Nutritional Supplement, Given as a Drink Before Gallbladder Surgery

NCT00662376 | Completed

• 1 other identifier: N-POB-01-UK
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Enteral Nutrition Regimen Prior to Surgery

Outcome Measures

Primary Outcomes (3)

• Safety parameters reflecting pathophysiological functions of the liver

  day -1, 0, 1, and 7

• Gastrointestinal tolerance

  day 0 before and 6-8h after surgery

• Metabolic parameters in serum, liver and muscle tissue

  on day -1, 0, 1, and 7

Secondary Outcomes (1)

• Clinical parameters (infectious and non-infectious complications)

  until day 7

Study Arms (2)

Test

EXPERIMENTAL

oral nutritional supplement (assignment: according to consecutive random numbers)

Dietary Supplement: PreOP Booster (oral nutritional supplement, food for special medical purposes)

Control

PLACEBO COMPARATOR

placebo (assignment: according to consecutive random numbers)

Dietary Supplement: PreOP Booster (oral nutritional supplement, food for special medical purposes)

Interventions

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

Control; Test

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• elective laparoscopic cholecystectomy

You may not qualify if:

• 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

Sponsors & Collaborators

• Fresenius Kabi: lead

Study Sites (1)

Queen's Medical Centre, Division of Gastrointestinal Surgery, Nottingham University Hospitals;

Nottingham, United Kingdom

Location

Related Publications (2)

• 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.

  PMID: 22444237 DERIVED

• 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.

  PMID: 20622656 DERIVED

MeSH Terms

Interventions

Dietary Supplements; Food

Intervention Hierarchy (Ancestors)

Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Dileep N. Lobo, MS, DM, FRCS

  Queen's Medical Centre, Division of Gastrointestinal Surgery, Nottingham University Hospitals;

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: April 17, 2008
• First Posted: April 21, 2008
• Study Start: April 1, 2008
• Primary Completion: October 1, 2008
• Study Completion: October 1, 2008
• Last Updated: December 8, 2008

Record last verified: 2008-11

Locations

GB (1)