StarvationPhase 4NCT00943020
Effects of Glutamine on Gastric Emptying
A Phase 4 study testing Nutricia PreOp nutritional supplement, Lipid and Glutamine in people with Starvation, run by University of Nottingham at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Starvation
- What is being tested?
- Nutricia PreOp nutritional supplement, Lipid and Glutamine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jul 2009to Nov 2009
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Nottingham Digestive Diseases Centre Biomedical Research Unit
Nottingham, Nottinghamshire, NG7 2UH
About this study
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
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.
Read the 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).
- Conditions
- Starvation
- Being tested
- Nutricia PreOp nutritional supplement, Lipid, Glutamine
- Keywords
- Dietary supplement, Carbohydrate loading, Healthy volunteers, Anaesthesia, Surgery, Glutamine
- Medical subject headings
- Starvation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nutricia PreOp nutritional supplementDietary supplement
nutritional supplement
LipidDietary supplement
Drink
GlutamineDietary supplement
Drink
| Study group | Role | What they receive |
|---|---|---|
| Nutricia PreOp + Lipid | Active comparator | Nutricia PreOp + Lipid Receives: Dietary Supplement: Nutricia PreOp nutritional supplement; Dietary Supplement: Lipid |
| Nutrica PreOP + Glutamine | Active comparator | Nutrica PreOP + Glutamine Receives: Dietary Supplement: Nutricia PreOp nutritional supplement; Dietary Supplement: Glutamine |
| Nutricia PreOP | Experimental | Nutricia PreOP: carbohydrate only drink Receives: Dietary Supplement: Nutricia PreOp nutritional supplement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gastric emptying time following supplementation of a standardised carbohydrate drink with glutamine.
Measured: 4 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2009 (estimated)
- Study startJul 2009
- Primary completionNov 2009
- Study completionNov 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for StarvationStudies of the same condition, open and under way.
- More trials run by University of NottinghamThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Nottingham
- Sponsor type
- University, hospital or other
- Investigators
- Dileep N Lobo, FRCS, Principal investigator, University of Nottingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00943020
- Sponsor's protocol ID
- 09026
- Status last verified
- Nov 2009
- First submitted
- 17 Jul 2009
- Last updated
- 17 Nov 2009
- Results posted
- No
- Data monitoring committee
- No
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.
PubMed 19446932Awad 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.
PubMed 20971535
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00943020
- Acronym / sponsor ID
- 09026
- Conditions
- Starvation
- Keywords
- Dietary supplement, Carbohydrate loading, Healthy volunteers, Anaesthesia, Surgery, Glutamine
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- University of NottinghamUniversity, hospital or other
- Study start
- Jul 2009
- Primary completion
- Nov 2009 (actual)
- Study completion
- Nov 2009 (actual)
- First posted
- 21 Jul 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Nutricia PreOp + Lipid | Active comparator | Dietary Supplement: Nutricia PreOp nutritional supplement, Dietary Supplement: LipidNutricia PreOp + Lipid |
| Nutrica PreOP + Glutamine | Active comparator | Dietary Supplement: Nutricia PreOp nutritional supplement, Dietary Supplement: GlutamineNutrica PreOP + Glutamine |
| Nutricia PreOP | Experimental | Dietary Supplement: Nutricia PreOp nutritional supplementNutricia PreOP: carbohydrate only drink |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nutricia PreOp nutritional supplementnutritional supplement | Dietary supplement | Nutrica PreOP + Glutamine, Nutricia PreOP, Nutricia PreOp + Lipid |
| LipidDrink | Dietary supplement | Nutricia PreOp + Lipid |
| GlutamineDrink | Dietary supplement | Nutrica PreOP + Glutamine |
Primary outcome
Gastric emptying time following supplementation of a standardised carbohydrate drink with glutamine.
Time frame: 4 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Nov 2009.
- Background: PubMed 19446932Awad 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.
- Derived from this study: PubMed 20971535Awad 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dileep N Lobo, FRCS principal investigator
University of Nottingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Nutricia PreOp nutritional supplement, Lipid and Glutamine in people with Starvation, run by University of Nottingham at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Nov 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gastric emptying time following supplementation of a standardised carbohydrate drink with glutamine. (time frame: 4 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00943020, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Nov 2009.