Metabolic Response Following Intake of 2 Metabolic Preconditioning Drinks

NCT ID: NCT00909701

Last Updated: 2009-07-20

Study Results

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-05-31

Study Completion Date

2009-05-31

Brief Summary

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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

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Conditions

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Starvation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Test

PreOP Booster (Fresenius Kabi, Bad Homburg, Germany)

Group Type EXPERIMENTAL

PreOP Booster

Intervention Type DIETARY_SUPPLEMENT

1 serving of 400 ml per study arm

Comparator

PreOP (Nutricia Clinical Care, Trowbridge, UK)

Group Type ACTIVE_COMPARATOR

PreOP (Nutricia Clinical Care, Trowbridge, UK)

Intervention Type DIETARY_SUPPLEMENT

1 serving of 400 ml per study arm

Interventions

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PreOP Booster

1 serving of 400 ml per study arm

Intervention Type DIETARY_SUPPLEMENT

PreOP (Nutricia Clinical Care, Trowbridge, UK)

1 serving of 400 ml per study arm

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Enhanced Recovery After Surgery Group (part of ESPEN)

UNKNOWN

Sponsor Role collaborator

University of Nottingham

OTHER

Sponsor Role lead

Responsible Party

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University of Nottingham

Principal Investigators

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Dileep Lobo, FRCS

Role: STUDY_CHAIR

University of Nottingham

Locations

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Nottingham Digestive Diseases Centre Biomedical Research Unit

Nottingham, Nottinghamshire, United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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B/12/2008

Identifier Type: -

Identifier Source: org_study_id

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