Metabolic Response Following Intake of 2 Metabolic Preconditioning Drinks

NCT00909701 | Completed

• 1 other identifier: B/12/2008
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Starvation

Keywords

Dietary supplement; healthy volunteers; Anaesthesia for surgery

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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)

Study Arms (2)

Test

EXPERIMENTAL

PreOP Booster (Fresenius Kabi, Bad Homburg, Germany)

Dietary Supplement: PreOP Booster

Comparator

ACTIVE COMPARATOR

PreOP (Nutricia Clinical Care, Trowbridge, UK)

Dietary Supplement: PreOP (Nutricia Clinical Care, Trowbridge, UK)

Interventions

PreOP Booster DIETARY_SUPPLEMENT

1 serving of 400 ml per study arm

Test

PreOP (Nutricia Clinical Care, Trowbridge, UK) DIETARY_SUPPLEMENT

1 serving of 400 ml per study arm

Comparator

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Nottingham: lead
• Enhanced Recovery After Surgery Group (part of ESPEN): collaborator

Study Sites (1)

Nottingham Digestive Diseases Centre Biomedical Research Unit

Nottingham, Nottinghamshire, NG7 2UH, United Kingdom

Location

MeSH Terms

Conditions

Starvation

Condition Hierarchy (Ancestors)

Malnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases

Study Officials

• Dileep Lobo, FRCS

  University of Nottingham

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: May 27, 2009
• First Posted: May 28, 2009
• Study Start: May 1, 2009
• Primary Completion: May 1, 2009
• Study Completion: May 1, 2009
• Last Updated: July 20, 2009

Record last verified: 2009-07

Locations

GB (1)