Effects of Glutamine on Gastric Emptying
Primary Purpose
Starvation
Status
Completed
Phase
Phase 4
Locations
United Kingdom
Study Type
Interventional
Intervention
Nutricia PreOp nutritional supplement
Lipid
Glutamine
Sponsored by
About this trial
This is an interventional basic science trial for Starvation focused on measuring Dietary supplement, Carbohydrate loading, Healthy volunteers, Anaesthesia, Surgery, Glutamine
Eligibility Criteria
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.
Sites / Locations
- Nottingham Digestive Diseases Centre Biomedical Research Unit
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Experimental
Arm Label
Nutricia PreOp + Lipid
Nutrica PreOP + Glutamine
Nutricia PreOP
Arm Description
Nutricia PreOp + Lipid
Nutrica PreOP + Glutamine
Nutricia PreOP: carbohydrate only drink
Outcomes
Primary Outcome Measures
Gastric emptying time following supplementation of a standardised carbohydrate drink with glutamine.
Secondary Outcome Measures
Full Information
NCT ID
NCT00943020
First Posted
July 17, 2009
Last Updated
November 15, 2009
Sponsor
University of Nottingham
1. Study Identification
Unique Protocol Identification Number
NCT00943020
Brief Title
Effects of Glutamine on Gastric Emptying
Official Title
The Effects of Supplementing Glutamine on the Gastric Emptying Time of a Preoperative Metabolic Conditioning Drink in Healthy Volunteers: a Randomized Crossover Pilot Study
Study Type
Interventional
2. Study Status
Record Verification Date
November 2009
Overall Recruitment Status
Completed
Study Start Date
July 2009 (undefined)
Primary Completion Date
November 2009 (Actual)
Study Completion Date
November 2009 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
University of Nottingham
4. Oversight
Data Monitoring Committee
No
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Starvation
Keywords
Dietary supplement, Carbohydrate loading, Healthy volunteers, Anaesthesia, Surgery, Glutamine
7. Study Design
Primary Purpose
Basic Science
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
15 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Nutricia PreOp + Lipid
Arm Type
Active Comparator
Arm Description
Nutricia PreOp + Lipid
Arm Title
Nutrica PreOP + Glutamine
Arm Type
Active Comparator
Arm Description
Nutrica PreOP + Glutamine
Arm Title
Nutricia PreOP
Arm Type
Experimental
Arm Description
Nutricia PreOP: carbohydrate only drink
Intervention Type
Dietary Supplement
Intervention Name(s)
Nutricia PreOp nutritional supplement
Intervention Description
nutritional supplement
Intervention Type
Dietary Supplement
Intervention Name(s)
Lipid
Intervention Description
Drink
Intervention Type
Dietary Supplement
Intervention Name(s)
Glutamine
Intervention Description
Drink
Primary Outcome Measure Information:
Title
Gastric emptying time following supplementation of a standardised carbohydrate drink with glutamine.
Time Frame
4 hours
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dileep N Lobo, FRCS
Organizational Affiliation
University of Nottingham
Official's Role
Principal Investigator
Facility Information:
Facility Name
Nottingham Digestive Diseases Centre Biomedical Research Unit
City
Nottingham
State/Province
Nottinghamshire
ZIP/Postal Code
NG7 2UH
Country
United Kingdom
12. IPD Sharing Statement
Citations:
PubMed Identifier
19446932
Citation
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.
Results Reference
background
PubMed Identifier
20971535
Citation
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.
Results Reference
derived
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Effects of Glutamine on Gastric Emptying
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