Metabolic Response Following Intake of 2 Metabolic Preconditioning Drinks

This study has been completed.
Sponsor:
Collaborator:
Enhanced Recovery After Surgery Group (part of ESPEN)
Information provided by:
University of Nottingham
ClinicalTrials.gov Identifier:
NCT00909701
First received: May 27, 2009
Last updated: July 17, 2009
Last verified: July 2009
  Purpose

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.


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

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Investigating the Metabolic Response Following Intake of 2 Metabolic Preconditioning Drinks: a Randomized Double-blind Crossover Healthy Volunteer Study

Resource links provided by NLM:


Further study details as provided by University of Nottingham:

Primary Outcome Measures:
  • 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) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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) ] [ Designated as safety issue: No ]

Estimated Enrollment: 15
Study Start Date: May 2009
Study Completion Date: May 2009
Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00909701

Locations
United Kingdom
Nottingham Digestive Diseases Centre Biomedical Research Unit
Nottingham, Nottinghamshire, United Kingdom, NG7 2UH
Sponsors and Collaborators
University of Nottingham
Enhanced Recovery After Surgery Group (part of ESPEN)
Investigators
Study Chair: Dileep Lobo, FRCS University of Nottingham
  More Information

No publications provided

Responsible Party: Mr. Paul Cartledge, University of Nottingham
ClinicalTrials.gov Identifier: NCT00909701     History of Changes
Other Study ID Numbers: B/12/2008
Study First Received: May 27, 2009
Last Updated: July 17, 2009
Health Authority: United Kingdom: Research Ethics Committee

Keywords provided by University of Nottingham:
Dietary supplement
healthy volunteers
Anaesthesia for surgery

Additional relevant MeSH terms:
Starvation
Malnutrition
Nutrition Disorders

ClinicalTrials.gov processed this record on August 21, 2014