Metabolic Response Following Intake of 2 Metabolic Preconditioning Drinks

July 17, 2009 updated by: University of Nottingham

Investigating the Metabolic Response Following Intake of 2 Metabolic Preconditioning Drinks: a Randomized Double-blind Crossover Healthy Volunteer Study

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

15

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
    • Nottinghamshire
      • Nottingham, Nottinghamshire, United Kingdom, NG7 2UH
        • Nottingham Digestive Diseases Centre Biomedical Research Unit

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 38 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Test
PreOP Booster (Fresenius Kabi, Bad Homburg, Germany)
Dietary supplement: PreOP Booster
1 serving of 400 ml per study arm
Active Comparator: Comparator
PreOP (Nutricia Clinical Care, Trowbridge, UK)
Dietary supplement: PreOP (Nutricia Clinical Care, Trowbridge, UK)
1 serving of 400 ml per study arm

What is the study measuring?

Primary Outcome Measures

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

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Nottingham

Collaborators

Enhanced Recovery After Surgery Group (part of ESPEN)

Investigators

  • Study Chair: Dileep Lobo, FRCS, University of Nottingham

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2009

Primary Completion (Actual)

May 1, 2009

Study Completion (Actual)

May 1, 2009

Study Registration Dates

First Submitted

May 27, 2009

First Submitted That Met QC Criteria

May 27, 2009

First Posted (Estimate)

May 28, 2009

Study Record Updates

Last Update Posted (Estimate)

July 20, 2009

Last Update Submitted That Met QC Criteria

July 17, 2009

Last Verified

July 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • B/12/2008

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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