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Effects of Glutamine on Gastric Emptying

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00943020
Recruitment Status : Completed
First Posted : July 21, 2009
Last Update Posted : November 17, 2009
Sponsor:
Information provided by:
University of Nottingham

Tracking Information
First Submitted Date  ICMJE July 17, 2009
First Posted Date  ICMJE July 21, 2009
Last Update Posted Date November 17, 2009
Study Start Date  ICMJE July 2009
Actual Primary Completion Date November 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 20, 2009)
Gastric emptying time following supplementation of a standardised carbohydrate drink with glutamine. [ Time Frame: 4 hours ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effects of Glutamine on Gastric Emptying
Official Title  ICMJE The Effects of Supplementing Glutamine on the Gastric Emptying Time of a Preoperative Metabolic Conditioning Drink in Healthy Volunteers: a Randomized Crossover Pilot Study
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.
Detailed Description

The eligibility criteria for this study are as follows:

Interested participants will be asked to attend a screening interview during which the study procedures/risks/benefits will be explained, followed by a brief history and physical examination. If deemed necessary by the study investigator, a 7ml sample of blood will be taken for screening purposes. The volunteer will be deemed eligible for the study once they have passed the screening visit and [when performed] had normal screening blood investigation results.

Each volunteer will be studied 3 times, the order of which will be determined randomly by computer. Participants will report for the study at the Division of GI Surgery (E−floor, West Block, Queen's Medical Centre), at 7:15am. On arrival the subject's height and weight will be recorded and 'drip needle' will will be placed in the back of the wrist. The hand will be rested in a hand−heater allowing venous blood to be sampled.

The subject will be randomly allocated to receive one of the three study drinks. At 7:50am baseline blood will be sampled (10ml [1.5 tablespoons] via the drip needle). At 8am the volunteers will drink the study drink. The rate of stomach emptying will be measured by using Gamma scintigraphy (a specialised medical camera). The drinks will have added a tracer substance that is visible on the camera and allows us to follow drink as it passes through the stomach into the bowels. Each 'picture' of the stomach lasts 20 seconds and we plan to take these every 20 minutes for 4 hours after intake of the drink. At 20 minute intervals (until 220 mins have elapsed) 7ml (1 tablespoon) of blood will be sampled via the drip needle. The final 10 ml blood sample will be taken at 240 minutes following which the drip needle will be removed and the volunteers will be allowed home. The subsequent two studies will be performed 7 days following the first study.

In total 95ml (a sixth of a pint) blood will be taken during each of the 3 crossover studies which will be separated by a period of 7 days (i.e. a total of 285 ml [half a pint] blood will be required from each volunteer).

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Investigator)
Primary Purpose: Basic Science
Condition  ICMJE Starvation
Intervention  ICMJE
  • Dietary Supplement: Nutricia PreOp nutritional supplement
    nutritional supplement
  • Dietary Supplement: Lipid
    Drink
  • Dietary Supplement: Glutamine
    Drink
Study Arms  ICMJE
  • Active Comparator: Nutricia PreOp + Lipid
    Nutricia PreOp + Lipid
    Interventions:
    • Dietary Supplement: Nutricia PreOp nutritional supplement
    • Dietary Supplement: Lipid
  • Active Comparator: Nutrica PreOP + Glutamine
    Nutrica PreOP + Glutamine
    Interventions:
    • Dietary Supplement: Nutricia PreOp nutritional supplement
    • Dietary Supplement: Glutamine
  • Experimental: Nutricia PreOP
    Nutricia PreOP: carbohydrate only drink
    Intervention: Dietary Supplement: Nutricia PreOp nutritional supplement
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Estimated Enrollment  ICMJE
 (submitted: July 20, 2009)
15
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE November 2009
Actual Primary Completion Date November 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 18 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00943020
Other Study ID Numbers  ICMJE 09026
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Mr Dileep N Lobo, University of Nottingham
Study Sponsor  ICMJE University of Nottingham
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Dileep N Lobo, FRCS University of Nottingham
PRS Account University of Nottingham
Verification Date November 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP