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Metabolic Response Following Intake of 2 Metabolic Preconditioning Drinks

U

University of Nottingham

Status

Completed

Conditions

Starvation

Treatments

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

Study type

Interventional

Funder types

Other

Identifiers

NCT00909701
B/12/2008

Details and patient eligibility

About

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.

Enrollment

15 estimated patients

Sex

Male

Ages

18 to 40 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Basic Science

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Quadruple Blind

15 participants in 2 patient groups

Test
Experimental group
Description:
PreOP Booster (Fresenius Kabi, Bad Homburg, Germany)
Treatment:
Dietary Supplement: PreOP Booster
Comparator
Active Comparator group
Description:
PreOP (Nutricia Clinical Care, Trowbridge, UK)
Treatment:
Dietary Supplement: PreOP (Nutricia Clinical Care, Trowbridge, UK)

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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