NCT00943020

Brief Summary

Surgical patients are usually starved for 8 hours before operation in order to ensure the stomach is empty and thus reduce the chances of vomiting during the anaesthetic. Recent studies have shown that this period of starvation is harmful as it 'weakens' the body before operation. To avoid the harmful effects of starvation, patients are now given carbohydrate (sugar-containing) drinks 2 to 4 hours before surgery. These drinks have been shown to make patients feel better, reduce sickness after the anaesthetic/surgery and result in a quicker recovery from operation. The optimum time of giving these drinks to patients before operation is unknown. Previous studies have shown that the drinks empty from the stomach within 2 - 4 hours depending on their ingredients. The investigators would like to study the effects of adding protein and fat to these drinks on how quickly the drinks empty from the stomach. This study will investigate the hormone responses of the body following intake of 3 different drinks in order to determine the mechanisms that underlie the control of stomach emptying. This information will also allow us to improve the design of these drinks and this could help patients who undergo surgery who receive them.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Jul 2009

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2009

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

July 17, 2009

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 21, 2009

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2009

Completed
Last Updated

November 17, 2009

Status Verified

November 1, 2009

Enrollment Period

4 months

First QC Date

July 17, 2009

Last Update Submit

November 15, 2009

Conditions

Starvation

Keywords

Dietary supplementCarbohydrate loadingHealthy volunteersAnaesthesiaSurgeryGlutamine

Outcome Measures

Primary Outcomes (1)

  • Gastric emptying time following supplementation of a standardised carbohydrate drink with glutamine.

    4 hours

Study Arms (3)

Nutricia PreOp + Lipid

ACTIVE COMPARATOR

Nutricia PreOp + Lipid

Dietary Supplement: Nutricia PreOp nutritional supplementDietary Supplement: Lipid

Nutrica PreOP + Glutamine

ACTIVE COMPARATOR

Nutrica PreOP + Glutamine

Dietary Supplement: Nutricia PreOp nutritional supplementDietary Supplement: Glutamine

Nutricia PreOP

EXPERIMENTAL

Nutricia PreOP: carbohydrate only drink

Dietary Supplement: Nutricia PreOp nutritional supplement

Interventions

Nutricia PreOp nutritional supplementDIETARY_SUPPLEMENT

nutritional supplement

Nutrica PreOP + GlutamineNutricia PreOPNutricia PreOp + Lipid
LipidDIETARY_SUPPLEMENT

Drink

Nutricia PreOp + Lipid
GlutamineDIETARY_SUPPLEMENT

Drink

Nutrica PreOP + Glutamine

Eligibility Criteria

Age18 Years - 60 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy male Caucasian volunteers aged 18-60 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 publication, and agree to co-operate with the study procedures.

You may not qualify if:

  • Any history of acute or chronic illness,
  • Smoking,
  • Regular medication or substance abuse,
  • Have taken part in any other clinical study within the previous 3 months.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nottingham Digestive Diseases Centre Biomedical Research Unit

Nottingham, Nottinghamshire, NG7 2UH, United Kingdom

Location

Related Publications (2)

  • Awad S, Constantin-Teodosiu D, Macdonald IA, Lobo DN. Short-term starvation and mitochondrial dysfunction - a possible mechanism leading to postoperative insulin resistance. Clin Nutr. 2009 Oct;28(5):497-509. doi: 10.1016/j.clnu.2009.04.014. Epub 2009 May 17.

    PMID: 19446932BACKGROUND

  • Awad S, Blackshaw PE, Wright JW, Macdonald IA, Perkins AC, Lobo DN. A randomized crossover study of the effects of glutamine and lipid on the gastric emptying time of a preoperative carbohydrate drink. Clin Nutr. 2011 Apr;30(2):165-71. doi: 10.1016/j.clnu.2010.09.008. Epub 2010 Oct 23.

    PMID: 20971535DERIVED

MeSH Terms

Conditions

Starvation

Interventions

LipidsGlutamine

Condition Hierarchy (Ancestors)

MalnutritionNutrition DisordersNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Amino Acids, BasicAmino AcidsAmino Acids, Peptides, and ProteinsAmino Acids, DiaminoAmino Acids, Neutral

Study Officials

  • Dileep N Lobo, FRCS

    University of Nottingham

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 17, 2009

First Posted

July 21, 2009

Study Start

July 1, 2009

Primary Completion

November 1, 2009

Study Completion

November 1, 2009

Last Updated

November 17, 2009

Record last verified: 2009-11

Locations

GB(1)