Effects of Glutamine on Gastric Emptying
Lykilorð
Útdráttur
Lýsing
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).
Dagsetningar
Síðast staðfest: | 10/31/2009 |
Fyrst lagt fram: | 07/16/2009 |
Áætluð skráning lögð fram: | 07/19/2009 |
Fyrst sent: | 07/20/2009 |
Síðasta uppfærsla lögð fram: | 11/14/2009 |
Síðasta uppfærsla sett upp: | 11/16/2009 |
Raunverulegur upphafsdagur náms: | 06/30/2009 |
Áætlaður aðallokunardagur: | 10/31/2009 |
Áætlaður dagsetningu rannsóknar: | 10/31/2009 |
Ástand eða sjúkdómur
Íhlutun / meðferð
Dietary Supplement: Nutricia PreOp nutritional supplement
Dietary Supplement: Nutricia PreOp + Lipid
Dietary Supplement: Nutrica PreOP + Glutamine
Stig
Armhópar
Armur | Íhlutun / meðferð |
---|---|
Active Comparator: Nutricia PreOp + Lipid Nutricia PreOp + Lipid | Dietary Supplement: Nutricia PreOp + Lipid Drink |
Active Comparator: Nutrica PreOP + Glutamine Nutrica PreOP + Glutamine | Dietary Supplement: Nutrica PreOP + Glutamine Drink |
Experimental: Nutricia PreOP Nutricia PreOP: carbohydrate only drink |
Hæfniskröfur
Aldur hæfur til náms | 18 Years Til 18 Years |
Kyn sem eru hæf til náms | Male |
Tekur við heilbrigðum sjálfboðaliðum | Já |
Viðmið | 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. |
Útkoma
Aðal niðurstöður ráðstafanir
1. Gastric emptying time following supplementation of a standardised carbohydrate drink with glutamine. [4 hours]