Peptic UlcerPhase 2/3NCT01828645
Residual Gastric Volume After the Ingestion of a Beverage Containing Carbohydrates Plus Whey Protein
A Phase 2/3 study testing Carbohydrate plus whey protein enriched drink in people with Peptic Ulcer and Gastritis, run by Federal University of Mato Grosso at 1 site in Brazil.
Trial summary
Carbohydrate enriched-drinks has been used as preoperative treatment up to two hours before anesthesia. These drinks are safe and are not associated to bronchial aspiration during anesthesia. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Peptic Ulcer, Gastritis
- What is being tested?
- Carbohydrate plus whey protein enriched drink
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteBrazil
- Study dates
- Feb 2013to Mar 2013
- Phase
- Phase 2/3
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients scheduled to upper digestive endoscopy for diagnostic purposes due to complaints of epigastric burning.
Who cannot join
- American Society of Anesthesiologists (ASA) score above II, diabetes mellitus, pregnancy, renal or hepatic failure, gastroesophageal reflux, acute cholecystitis, use of corticosteroids up to 6 months previously, use of any prokynetic drug up to 6 weeks, and any noncompliance or violation on the assigned protocol of preoperative fasting.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Residual Gastric Volume Measured by Upper Digestive Endoscopy 2h After the Ingestion of a Beverage Containing Carbohydrates Plus Whey Protein. A Controlled, Randomized Clinical Trial
Carbohydrate enriched-drinks has been used as preoperative treatment up to two hours before anesthesia. These drinks are safe and are not associated to bronchial aspiration during anesthesia. The addition of protein may be beneficial for metabolic preconditioning but there is a few data in literature testing these drinks for safety. The aim of the study will be to investigate the residual gastric volume (RGV) measured during the gastroscopy with abbreviation of fast to 2h with a carbohydrate plus whey protein enriched-drink.
Read the detailed description
The use of carbohydrate-rich beverage in the immediate preoperative period is not only safe, but may also reduce the catabolic stress response, nausea, vomiting, and thus enhance postoperative recovery.The addition of protein may increase the benefits but there are few studies on this matter. Several studies have also shown the nutritional qualities of soluble whey proteins. Whey protein contains a high level of essential amino acids especially branched-chain amino acids. The digestibility and gastric emptying is accelerated when compared to casein. We thought that gastroscopy would be an excellent model to test the gastric emptying of such drinks before testing it for elective operations. Thus, the aim of the study will be to investigate the residual gastric volume (RGV) measured during the gastroscopy with abbreviation of fast to 2h with a carbohydrate- whey protein-drink.
Methods A group of adult patients (age ranging from 18 to 72years-old) scheduled to undergoing upper digestive endoscopy for diagnostic purposes due to epigastric burning at Gastroclinica, Cuiabá, Brazil will be eligible for inclusion in this trial. Exclusion criteria will be: American Society of Anesthesiologists (ASA) score above II, diabetes mellitus, pregnancy, renal or hepatic failure, gastroesophageal reflux, morbid obesity (BMI above 40 kg/m2,acute cholecystitis, use of corticosteroids up to 6 months previously, use of any prokinetic drug up to 6 weeks, and any noncompliance or violation on the assigned protocol of preoperative fasting. The local ethics committee approved the study, and all patients will authorize his/her inclusion in the study by written informed consent.
Randomization A staff not involved with the study will proceed with the randomization process. A computer program will generate random numbers to assign patients to the two groups. Patients will be randomized to receive either conventional preoperative fasting of 8 hours (fasted group, n=15) or will receive instruction to 2 hours fast (study group, n=15). Patients belonging to study group will fast for solids for 8h and will drink 200mL of a beverage containing maltodextrine in addition to whey protein (Fresubin Jucy, Fresenius Kabi, Brazil) 2 hours before the initiation of sedation with propofol for the endoscopic exam.
Fasting protocol All patients will receive both oral and written information about the protocol at the outpatient clinic. Endoscopies will be scheduled to begin at 8:00 AM. The evening before operation patients will be free to ingest solid food until 11:00 PM. The patients belonging to the abbreviation of fasting will receive written instructions to ingest the above beverage at 6:00 AM (200 mL), and be at the Gastroclinica unit at 7:00 AM.
Endoscopy protocol Endoscopy will be performed by a certified gastroenterologist staff as routine. Special attention will be done for RGV. The finding of any residual gastric contents will mean that the content will be aspirate and measured. The RGV measured in mL will be the main outcome measure of the study.
Outcome variable and statistical analysis The main endpoint of the study was the RGV. Comparison of RGV between the two groups will be done by either Student t test or Mann-Whitney test. A 5% will be established as significant level.
- Conditions
- Peptic Ulcer, Gastritis
- Being tested
- Carbohydrate plus whey protein enriched drink
- Keywords
- gastric emptying, whey protein, carbohydrate, fasting
- Medical subject headings
- Peptic Ulcer, Gastritis, Fasting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Carbohydrate plus whey protein enriched drinkDietary supplement
Also called Jucy (Fresenius Kabi, Brazil), Study group
The patients will drink 200 mL of the nutritional supplement (Jucy, Fresenius Kabi, Brazil) 2h before upper digestive endoscopy under sedation with propofol.
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Patients will be submitted to upper digestive endoscopy in the morning bearing traditional NPO (nil per oral)fast after 11:00PM |
| Intervention | Experimental | The patients belonging to the intervention group will fast from 11:00 PM the night before but will drink 200 mL of a Carbohydrate plus whey protein enriched drink 2h before the exam. Receives: Dietary Supplement: Carbohydrate plus whey protein enriched drink |
What is being measured
The primary outcome is the main question the study is designed to answer.
Residual Gastric Volume
Endoscopy will be performed by a certified gastroenterologist staff as routine. Special attention will be done for Residual Gastric Volume (RGV). The finding of any residual gastric contents will mean that the contents will be aspirate and measured. The RGV measured in mL will be the main outcome measure of the study
Measured: 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2013 (estimated)
- Study startFeb 2013
- Primary completionMar 2013
- Study completionMar 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Peptic UlcerStudies of the same condition, open and under way.
- 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 2/3
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federal University of Mato Grosso
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jose Eduardo de Aguilar-Nascimento, Federal University of Mato Grosso
- Investigators
- JOSE E AGUILAR-NASCIMENTO, MD, PhD, Principal investigator, Federal University of Mato Grosso
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01828645
- Sponsor's protocol ID
- cho+whey protein safety
- Status last verified
- Apr 2013
- First submitted
- 8 Apr 2013
- Last updated
- 10 Apr 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Perrone F, da-Silva-Filho AC, Adorno IF, Anabuki NT, Leal FS, Colombo T, da Silva BD, Dock-Nascimento DB, Damiao A, de Aguilar-Nascimento JE. Effects of preoperative feeding with a whey protein plus carbohydrate drink on the acute phase response and insulin resistance. A randomized trial. Nutr J. 2011 Jun 13;10:66. doi: 10.1186/1475-2891-10-66.
PubMed 21668975
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Residual Gastric Volume Measured by Upper Digestive Endoscopy 2h After the Ingestion of a Beverage Containing Carbohydrates Plus Whey Protein. A Controlled, Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT01828645
- Acronym / sponsor ID
- cho+whey protein safety
- Conditions
- Peptic Ulcer, Gastritis
- Keywords
- gastric emptying, whey protein, carbohydrate, fasting
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Federal University of Mato GrossoUniversity, hospital or other
- Study start
- Feb 2013
- Primary completion
- Mar 2013 (actual)
- Study completion
- Mar 2013 (actual)
- First posted
- 10 Apr 2013 (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.
Carbohydrate enriched-drinks has been used as preoperative treatment up to two hours before anesthesia. These drinks are safe and are not associated to bronchial aspiration during anesthesia. The addition of protein may be beneficial for metabolic preconditioning but there is a few data in literature testing these drinks for safety. The aim of the study will be to investigate the residual gastric volume (RGV) measured during the gastroscopy with abbreviation of fast to 2h with a carbohydrate plus whey protein enriched-drink.
Detailed description
The use of carbohydrate-rich beverage in the immediate preoperative period is not only safe, but may also reduce the catabolic stress response, nausea, vomiting, and thus enhance postoperative recovery.The addition of protein may increase the benefits but there are few studies on this matter. Several studies have also shown the nutritional qualities of soluble whey proteins. Whey protein contains a high level of essential amino acids especially branched-chain amino acids. The digestibility and gastric emptying is accelerated when compared to casein. We thought that gastroscopy would be an excellent model to test the gastric emptying of such drinks before testing it for elective operations. Thus, the aim of the study will be to investigate the residual gastric volume (RGV) measured during the gastroscopy with abbreviation of fast to 2h with a carbohydrate- whey protein-drink.
Methods A group of adult patients (age ranging from 18 to 72years-old) scheduled to undergoing upper digestive endoscopy for diagnostic purposes due to epigastric burning at Gastroclinica, Cuiabá, Brazil will be eligible for inclusion in this trial. Exclusion criteria will be: American Society of Anesthesiologists (ASA) score above II, diabetes mellitus, pregnancy, renal or hepatic failure, gastroesophageal reflux, morbid obesity (BMI above 40 kg/m2,acute cholecystitis, use of corticosteroids up to 6 months previously, use of any prokinetic drug up to 6 weeks, and any noncompliance or violation on the assigned protocol of preoperative fasting. The local ethics committee approved the study, and all patients will authorize his/her inclusion in the study by written informed consent.
Randomization A staff not involved with the study will proceed with the randomization process. A computer program will generate random numbers to assign patients to the two groups. Patients will be randomized to receive either conventional preoperative fasting of 8 hours (fasted group, n=15) or will receive instruction to 2 hours fast (study group, n=15). Patients belonging to study group will fast for solids for 8h and will drink 200mL of a beverage containing maltodextrine in addition to whey protein (Fresubin Jucy, Fresenius Kabi, Brazil) 2 hours before the initiation of sedation with propofol for the endoscopic exam.
Fasting protocol All patients will receive both oral and written information about the protocol at the outpatient clinic. Endoscopies will be scheduled to begin at 8:00 AM. The evening before operation patients will be free to ingest solid food until 11:00 PM. The patients belonging to the abbreviation of fasting will receive written instructions to ingest the above beverage at 6:00 AM (200 mL), and be at the Gastroclinica unit at 7:00 AM.
Endoscopy protocol Endoscopy will be performed by a certified gastroenterologist staff as routine. Special attention will be done for RGV. The finding of any residual gastric contents will mean that the content will be aspirate and measured. The RGV measured in mL will be the main outcome measure of the study.
Outcome variable and statistical analysis The main endpoint of the study was the RGV. Comparison of RGV between the two groups will be done by either Student t test or Mann-Whitney test. A 5% will be established as significant level.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Patients will be submitted to upper digestive endoscopy in the morning bearing traditional NPO (nil per oral)fast after 11:00PM |
| Intervention | Experimental | Dietary Supplement: Carbohydrate plus whey protein enriched drinkThe patients belonging to the intervention group will fast from 11:00 PM the night before but will drink 200 mL of a Carbohydrate plus whey protein enriched drink 2h before the exam. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- patients scheduled to upper digestive endoscopy for diagnostic purposes due to complaints of epigastric burning.
Key exclusion criteria (1 listed)
- American Society of Anesthesiologists (ASA) score above II, diabetes mellitus, pregnancy, renal or hepatic failure, gastroesophageal reflux, acute cholecystitis, use of corticosteroids up to 6 months previously, use of any prokynetic drug up to 6 weeks, and any noncompliance or violation on the assigned protocol of preoperative fasting.
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 |
|---|---|---|
| Carbohydrate plus whey protein enriched drinkAlso: Jucy (Fresenius Kabi, Brazil), Study groupThe patients will drink 200 mL of the nutritional supplement (Jucy, Fresenius Kabi, Brazil) 2h before upper digestive endoscopy under sedation with propofol. | Dietary supplement | Intervention |
Primary outcome
Residual Gastric Volume
Time frame: 2 hours
Endoscopy will be performed by a certified gastroenterologist staff as routine. Special attention will be done for Residual Gastric Volume (RGV). The finding of any residual gastric contents will mean that the contents will be aspirate and measured. The RGV measured in mL will be the main outcome measure of the study
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 10 Apr 2013.
- Background: PubMed 21668975Perrone F, da-Silva-Filho AC, Adorno IF, Anabuki NT, Leal FS, Colombo T, da Silva BD, Dock-Nascimento DB, Damiao A, de Aguilar-Nascimento JE. Effects of preoperative feeding with a whey protein plus carbohydrate drink on the acute phase response and insulin resistance. A randomized trial. Nutr J. 2011 Jun 13;10:66. doi: 10.1186/1475-2891-10-66.
Related trials for Peptic Ulcer
Active, not recruitingPhase 3
Study to Evaluate the Efficacy and Safety of Ilaprazole 10 mg in Prevention NSAIDs Associated Peptic Ulcer
Peptic Ulcer
Active, not recruiting
To Develop Methods for the Rehabilitation of Chronic Gastroduodenal Pathology in Children.
Gastritis Chronic, Gastroduodenitis
RecruitingPhase 4
Efficacy and Safety of Vonorasan Versus Esomeprazole in the Treatment of Ulcers After Endoscopic Submucosal Dissection
Ulcers, Gastric
Recruiting
SPADE Clinical Trial.
Early Gastric Cancer, Adenocarcinoma of the Stomach
RecruitingObservational study
Efficacy and Safety of Esomeprazole 40 mg IV in Post-Surgical Patients Admitted to the ICU
Stress Ulcers, Reflux Episodes
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.
JOSE E AGUILAR-NASCIMENTO, MD, PhD principal investigator
Federal University of Mato Grosso
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Carbohydrate plus whey protein enriched drink in people with Peptic Ulcer and Gastritis, run by Federal University of Mato Grosso at 1 site in Brazil.
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 1 inclusion and 1 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 10 Apr 2013. 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 Brazil. 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 combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Residual Gastric Volume (time frame: 2 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 NCT01828645, which also lists 1 linked publication.
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 10 Apr 2013.