Metabolic Response Following Intake of 2 Metabolic Preconditioning Drinks

Not Applicable

Completed

• Conditions: Starvation
• Interventions: Dietary Supplement: PreOP Booster; Dietary Supplement: PreOP (Nutricia Clinical Care, Trowbridge, UK)

• Registration Number: NCT00909701
• Lead Sponsor: University of Nottingham

Brief Summary

Surgical patients are usually starved for 8 to 12 hours before operation in order to reduce the chances of vomiting and other complications during the anaesthetic. Recent studies have suggested that this period of starvation might be harmful as it 'weakens' or 'stresses' the body before the operation. To avoid these harmful effects of starvation, patients are now given carbohydrate drinks (sugar-containing drinks that provide energy for the body) up to 2 hours before the operation. These drinks have been shown to make patients feel better, reduce sickness after the anesthetic/surgery and result in quicker recovery from operation. But the ways in which the sugar drinks have these beneficial effects on the body are unknown. The optimum time of giving these drinks to patients before operation is also unknown. This study will investigate the hormone responses of the body, following intake of 2 different carbohydrate drinks, in order to determine the optimum time of intake of these drinks in order to obtain the maximum benefits for the body.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-05
• Primary Completion: 2009-05
• Study Completion: 2009-05
• Study First Submitted: 2009-05-27
• Study First Submitted QC: 2009-05-27
• Study First Posted: 2009-05-28
• Status Verified: 2009-07
• Last Update Submitted: 2009-07-17
• Last Update Posted: 2009-07-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 15

Inclusion Criteria

• healthy male Caucasian volunteers aged 18-40 years,
• BMI of 20-25 kg/m2,
• able to give voluntary written informed consent to participate in the study, - able to understand the requirements of the study, including anonymous publications, AND
• agree to co-operate with the study procedure.

Exclusion Criteria

• any history of acute or chronic illness, smoking, regular medication or substance abuse, OR
• have taken part in any other clinical study within the previous 3 months.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Test	PreOP Booster	PreOP Booster (Fresenius Kabi, Bad Homburg, Germany)
Comparator	PreOP (Nutricia Clinical Care, Trowbridge, UK)	PreOP (Nutricia Clinical Care, Trowbridge, UK)

Primary Outcome Measures

Name	Time	Method
changes in plasma insulin and glucose levels	For 6 hours after intake of drink (blood samples will be taken at 20 min intervals for a total of 6 hours)

Secondary Outcome Measures

Name	Time	Method
Changes in plasma glucagon, non-esterified fatty acids and beta-hydroxybutyrate concentrations	For 6 hours after intake of drink (blood samples will be taken at 20 min intervals for a total of 6 hours)

Trial Locations

Locations (1)

Nottingham Digestive Diseases Centre Biomedical Research Unit; 🇬🇧 Nottingham, Nottinghamshire, United Kingdom