Metabolic Response Following Intake of 2 Metabolic Preconditioning Drinks
Primary Purpose
Starvation
Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
PreOP Booster
PreOP (Nutricia Clinical Care, Trowbridge, UK)
Sponsored by
About this trial
This is an interventional basic science trial for Starvation focused on measuring Dietary supplement, healthy volunteers, Anaesthesia for surgery
Eligibility 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.
Sites / Locations
- Nottingham Digestive Diseases Centre Biomedical Research Unit
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Test
Comparator
Arm Description
PreOP Booster (Fresenius Kabi, Bad Homburg, Germany)
PreOP (Nutricia Clinical Care, Trowbridge, UK)
Outcomes
Primary Outcome Measures
changes in plasma insulin and glucose levels
Secondary Outcome Measures
Changes in plasma glucagon, non-esterified fatty acids and beta-hydroxybutyrate concentrations
Full Information
NCT ID
NCT00909701
First Posted
May 27, 2009
Last Updated
July 17, 2009
Sponsor
University of Nottingham
Collaborators
Enhanced Recovery After Surgery Group (part of ESPEN)
1. Study Identification
Unique Protocol Identification Number
NCT00909701
Brief Title
Metabolic Response Following Intake of 2 Metabolic Preconditioning Drinks
Official Title
Investigating the Metabolic Response Following Intake of 2 Metabolic Preconditioning Drinks: a Randomized Double-blind Crossover Healthy Volunteer Study
Study Type
Interventional
2. Study Status
Record Verification Date
July 2009
Overall Recruitment Status
Completed
Study Start Date
May 2009 (undefined)
Primary Completion Date
May 2009 (Actual)
Study Completion Date
May 2009 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
University of Nottingham
Collaborators
Enhanced Recovery After Surgery Group (part of ESPEN)
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Starvation
Keywords
Dietary supplement, healthy volunteers, Anaesthesia for surgery
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
15 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Test
Arm Type
Experimental
Arm Description
PreOP Booster (Fresenius Kabi, Bad Homburg, Germany)
Arm Title
Comparator
Arm Type
Active Comparator
Arm Description
PreOP (Nutricia Clinical Care, Trowbridge, UK)
Intervention Type
Dietary Supplement
Intervention Name(s)
PreOP Booster
Intervention Description
1 serving of 400 ml per study arm
Intervention Type
Dietary Supplement
Intervention Name(s)
PreOP (Nutricia Clinical Care, Trowbridge, UK)
Intervention Description
1 serving of 400 ml per study arm
Primary Outcome Measure Information:
Title
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 Outcome Measure Information:
Title
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)
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dileep Lobo, FRCS
Organizational Affiliation
University of Nottingham
Official's Role
Study Chair
Facility Information:
Facility Name
Nottingham Digestive Diseases Centre Biomedical Research Unit
City
Nottingham
State/Province
Nottinghamshire
ZIP/Postal Code
NG7 2UH
Country
United Kingdom
12. IPD Sharing Statement
Learn more about this trial
Metabolic Response Following Intake of 2 Metabolic Preconditioning Drinks
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