- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00943020
Effects of Glutamine on Gastric Emptying
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 Overview
Status
Conditions
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
Enrollment (Anticipated)
Phase
- Phase 4
Contacts and Locations
Study Locations
-
-
Nottinghamshire
-
Nottingham, Nottinghamshire, United Kingdom, NG7 2UH
- Nottingham Digestive Diseases Centre Biomedical Research Unit
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Nutricia PreOp + Lipid
|
nutritional supplement
Drink
|
Active Comparator: Nutrica PreOP + Glutamine
|
nutritional supplement
Drink
|
Experimental: Nutricia PreOP
Nutricia PreOP: carbohydrate only drink
|
nutritional supplement
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Gastric emptying time following supplementation of a standardised carbohydrate drink with glutamine.
Time Frame: 4 hours
|
4 hours
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Dileep N Lobo, FRCS, University of Nottingham
Publications and helpful links
General Publications
- 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.
- 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.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 09026
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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