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Completed

NCT Number: NCT00909701

Metabolic Response Following Intake of 2 Metabolic Preconditioning Drinks

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.

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Key information

Conditions

Starvation Malnutrition Nutrition Disorders Nutritional and Metabolic Diseases

Age range

18 year–40 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Nottingham Digestive Diseases Centre Biomedical Research Unit

Nottingham, Nottinghamshire, NG7 2UH, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

PreOP Booster

Dietary Supplement

1 serving of 400 ml per study arm

PreOP (Nutricia Clinical Care, Trowbridge, UK)

Dietary Supplement

1 serving of 400 ml per study arm

Primary outcomes

  1. 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)

Secondary outcomes

  1. 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)

Sponsors and collaborators

Lead sponsor

University of Nottingham

Other

Collaborators

  • Enhanced Recovery After Surgery Group (part of ESPEN)

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2009
Study completion
2009
First posted
May 28, 2009
Registry last updated
Jul 20, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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