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Metabolic Response Following Intake of 2 Metabolic Preconditioning Drinks

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00909701
Enrollment
15
Registered
2009-05-28
Start date
2009-05-31
Completion date
2009-05-31
Last updated
2009-07-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Starvation

Keywords

Dietary supplement, healthy volunteers, Anaesthesia for surgery

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.

Interventions

DIETARY_SUPPLEMENTPreOP Booster

1 serving of 400 ml per study arm

DIETARY_SUPPLEMENTPreOP (Nutricia Clinical Care, Trowbridge, UK)

1 serving of 400 ml per study arm

Sponsors

Enhanced Recovery After Surgery Group (part of ESPEN)
CollaboratorUNKNOWN
University of Nottingham
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
MALE
Age
18 Years to 40 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frame
changes in plasma insulin and glucose levelsFor 6 hours after intake of drink (blood samples will be taken at 20 min intervals for a total of 6 hours)

Secondary

MeasureTime frame
Changes in plasma glucagon, non-esterified fatty acids and beta-hydroxybutyrate concentrationsFor 6 hours after intake of drink (blood samples will be taken at 20 min intervals for a total of 6 hours)

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026