Metabolic Response Following Intake of 2 Metabolic Preconditioning Drinks

Study Overview
=================
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.

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

Conditions
-----------------
Starvation

Intervention / Treatment
-----------------
* Dietary Supplement: PreOP Booster
* Dietary Supplement: PreOP (Nutricia Clinical Care, Trowbridge, UK)


Participation Criteria
=================
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
-----------------
Male

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Test<br>PreOP Booster (Fresenius Kabi, Bad Homburg, Germany) | Dietary Supplement: PreOP Booster<br>* 1 serving of 400 ml per study arm<br>|
| Active Comparator: Comparator<br>PreOP (Nutricia Clinical Care, Trowbridge, UK) | Dietary Supplement: PreOP (Nutricia Clinical Care, Trowbridge, UK)<br>* 1 serving of 400 ml per study arm<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Dietary supplement, healthy volunteers, Anaesthesia for surgery