Metabolic Response Following Intake of 2 Metabolic Preconditioning Drinks

Starvation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00909701
• Other study ID #: B/12/2008
• Status: Completed
• Phase: N/A
• First received: May 27, 2009
• Last updated: July 17, 2009
• Start date: May 2009
• Est. completion date: May 2009

Study information

• Verified date: July 2009
• Source: University of Nottingham
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Research Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: May 2009
• Est. primary completion date: May 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 40 Years

Eligibility

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.

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Starvation

Intervention

Dietary Supplement:
• PreOP Booster
1 serving of 400 ml per study arm
• PreOP (Nutricia Clinical Care, Trowbridge, UK)
1 serving of 400 ml per study arm

Locations

Country	Name	City	State
United Kingdom	Nottingham Digestive Diseases Centre Biomedical Research Unit	Nottingham	Nottinghamshire

Sponsors (2)

Lead Sponsor	Collaborator
University of Nottingham	Enhanced Recovery After Surgery Group (part of ESPEN)

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	changes in plasma insulin and glucose levels		For 6 hours after intake of drink (blood samples will be taken at 20 min intervals for a total of 6 hours)	No
Secondary	Changes in plasma glucagon, non-esterified fatty acids and beta-hydroxybutyrate concentrations		For 6 hours after intake of drink (blood samples will be taken at 20 min intervals for a total of 6 hours)	No