StarvationNCT00909701
Metabolic Response Following Intake of 2 Metabolic Preconditioning Drinks
A study testing PreOP Booster and PreOP (Nutricia Clinical Care, Trowbridge, UK) in people with Starvation, run by University of Nottingham at 1 site in United Kingdom.
Trial summary
Surgical patients are usually starved for 8 to 12 hours before operation in order to reduce the chances of vomiting and other complications during the anaesthetic. Recent studies have suggested that this period of starvation might be harmful as it 'weakens' or 'stresses' the body before the operation. Read more about this study
- Who is it for?
- Ages 18 to 40 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Starvation
- What is being tested?
- PreOP Booster and PreOP (Nutricia Clinical Care, Trowbridge, UK)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- May 2009to May 2009
- Phase
- Interventional
- 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 40 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- healthy male Caucasian volunteers aged 18-40 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 publications, AND
- agree to co-operate with the study procedure.
Who cannot join
- any history of acute or chronic illness, smoking, regular medication or substance abuse, OR
- 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: Investigating the Metabolic Response Following Intake of 2 Metabolic Preconditioning Drinks: a Randomized Double-blind Crossover Healthy Volunteer Study
Surgical patients are usually starved for 8 to 12 hours before operation in order to reduce the chances of vomiting and other complications during the anaesthetic. Recent studies have suggested that this period of starvation might be harmful as it 'weakens' or 'stresses' the body before the operation. To avoid these harmful effects of starvation, patients are now given carbohydrate drinks (sugar-containing drinks that provide energy for the body) up to 2 hours before the operation. These drinks have been shown to make patients feel better, reduce sickness after the anesthetic/surgery and result in quicker recovery from operation. But the ways in which the sugar drinks have these beneficial effects on the body are unknown. The optimum time of giving these drinks to patients before operation is also unknown. This study will investigate the hormone responses of the body, following intake of 2 different carbohydrate drinks, in order to determine the optimum time of intake of these drinks in order to obtain the maximum benefits for the body.
- Conditions
- Starvation
- Being tested
- PreOP Booster, PreOP (Nutricia Clinical Care, Trowbridge, UK)
- Keywords
- Dietary supplement, healthy volunteers, Anaesthesia for surgery
- Medical subject headings
- Starvation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PreOP BoosterDietary supplement
1 serving of 400 ml per study arm
PreOP (Nutricia Clinical Care, Trowbridge, UK)Dietary supplement
1 serving of 400 ml per study arm
| Study group | Role | What they receive |
|---|---|---|
| Test | Experimental | PreOP Booster (Fresenius Kabi, Bad Homburg, Germany) Receives: Dietary Supplement: PreOP Booster |
| Comparator | Active comparator | PreOP (Nutricia Clinical Care, Trowbridge, UK) Receives: Dietary Supplement: PreOP (Nutricia Clinical Care, Trowbridge, UK) |
What is being measured
The primary outcome is the main question the study is designed to answer.
changes in plasma insulin and glucose levels
Measured: For 6 hours after intake of drink (blood samples will be taken at 20 min intervals for a total of 6 hours)
Secondary outcomes (1)
Changes in plasma glucagon, non-esterified fatty acids and beta-hydroxybutyrate concentrations
Measured: For 6 hours after intake of drink (blood samples will be taken at 20 min intervals for a total of 6 hours)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2009 (estimated)
- Study startMay 2009
- Primary completionMay 2009
- Study completionMay 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Nottingham
- Sponsor type
- University, hospital or other
- Collaborators
- Enhanced Recovery After Surgery Group (part of ESPEN)
- Investigators
- Dileep Lobo, FRCS, Study chair, University of Nottingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00909701
- Sponsor's protocol ID
- B/12/2008
- Status last verified
- Jul 2009
- First submitted
- 27 May 2009
- Last updated
- 20 Jul 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating the Metabolic Response Following Intake of 2 Metabolic Preconditioning Drinks: a Randomized Double-blind Crossover Healthy Volunteer Study
- ClinicalTrials.gov ID
- NCT00909701
- Acronym / sponsor ID
- B/12/2008
- Conditions
- Starvation
- Keywords
- Dietary supplement, healthy volunteers, Anaesthesia for surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- University of NottinghamUniversity, hospital or other
- Collaborators
- Enhanced Recovery After Surgery Group (part of ESPEN)
- Study start
- May 2009
- Primary completion
- May 2009 (actual)
- Study completion
- May 2009 (actual)
- First posted
- 28 May 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 to 12 hours before operation in order to reduce the chances of vomiting and other complications during the anaesthetic. Recent studies have suggested that this period of starvation might be harmful as it 'weakens' or 'stresses' the body before the operation. To avoid these harmful effects of starvation, patients are now given carbohydrate drinks (sugar-containing drinks that provide energy for the body) up to 2 hours before the operation. These drinks have been shown to make patients feel better, reduce sickness after the anesthetic/surgery and result in quicker recovery from operation. But the ways in which the sugar drinks have these beneficial effects on the body are unknown. The optimum time of giving these drinks to patients before operation is also unknown. This study will investigate the hormone responses of the body, following intake of 2 different carbohydrate drinks, in order to determine the optimum time of intake of these drinks in order to obtain the maximum benefits for the body.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Test | Experimental | Dietary Supplement: PreOP BoosterPreOP Booster (Fresenius Kabi, Bad Homburg, Germany) |
| Comparator | Active comparator | Dietary Supplement: PreOP (Nutricia Clinical Care, Trowbridge, UK)PreOP (Nutricia Clinical Care, Trowbridge, UK) |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- healthy male Caucasian volunteers aged 18-40 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 publications, AND
- agree to co-operate with the study procedure.
Key exclusion criteria (2 listed)
- any history of acute or chronic illness, smoking, regular medication or substance abuse, OR
- 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 |
|---|---|---|
| PreOP Booster1 serving of 400 ml per study arm | Dietary supplement | Test |
| PreOP (Nutricia Clinical Care, Trowbridge, UK)1 serving of 400 ml per study arm | Dietary supplement | Comparator |
Primary outcome
changes in plasma insulin and glucose levels
Time frame: For 6 hours after intake of drink (blood samples will be taken at 20 min intervals for a total of 6 hours)
1 secondary outcome
Changes in plasma glucagon, non-esterified fatty acids and beta-hydroxybutyrate concentrations
Time frame: For 6 hours after intake of drink (blood samples will be taken at 20 min intervals for a total of 6 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 20 Jul 2009.
Related trials for Starvation
Active, not recruitingPhase 4
Impact of Early Parenteral Nutrition Completing Enteral Nutrition in Adult Critically Ill Patients
Critical Illness, Starvation
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 Lobo, FRCS study chair
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 study testing PreOP Booster and PreOP (Nutricia Clinical Care, Trowbridge, UK) 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 2 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 20 Jul 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.
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?
changes in plasma insulin and glucose levels (time frame: For 6 hours after intake of drink (blood samples will be taken at 20 min intervals for a total of 6 hours)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Jul 2009.