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Residual Gastric Volume After the Ingestion of a Beverage Containing Carbohydrates Plus Whey Protein

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ClinicalTrials.gov Identifier: NCT01828645
Recruitment Status : Completed
First Posted : April 10, 2013
Last Update Posted : April 10, 2013
Sponsor:
Information provided by (Responsible Party):
Jose Eduardo de Aguilar-Nascimento, Federal University of Mato Grosso

Tracking Information
First Submitted Date  ICMJE April 8, 2013
First Posted Date  ICMJE April 10, 2013
Last Update Posted Date April 10, 2013
Study Start Date  ICMJE February 2013
Actual Primary Completion Date March 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 8, 2013)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Residual Gastric Volume After the Ingestion of a Beverage Containing Carbohydrates Plus Whey Protein
Official Title  ICMJE 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
Brief 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. 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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Care Provider, Investigator, Outcomes Assessor)
Condition  ICMJE
  • Peptic Ulcer
  • Gastritis
Intervention  ICMJE Dietary Supplement: Carbohydrate plus whey protein enriched drink
The patients will drink 200 mL of the nutritional supplement (Jucy, Fresenius Kabi, Brazil) 2h before upper digestive endoscopy under sedation with propofol.
Other Names:
  • Jucy (Fresenius Kabi, Brazil)
  • Study group
Study Arms  ICMJE
  • No Intervention: Control
    Patients will be submitted to upper digestive endoscopy in the morning bearing traditional NPO (nil per oral)fast after 11:00PM
  • Experimental: Intervention
    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.
    Intervention: Dietary Supplement: Carbohydrate plus whey protein enriched drink
Publications * Perrone F, da-Silva-Filho AC, Adôrno IF, Anabuki NT, Leal FS, Colombo T, da Silva BD, Dock-Nascimento DB, Damião 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 8, 2013)
30
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE March 2013
Actual Primary Completion Date March 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

patients scheduled to upper digestive endoscopy for diagnostic purposes due to complaints of epigastric burning.

Exclusion Criteria:

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.

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Brazil
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01828645
Other Study ID Numbers  ICMJE cho+whey protein safety
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Jose Eduardo de Aguilar-Nascimento, Federal University of Mato Grosso
Study Sponsor  ICMJE Federal University of Mato Grosso
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: JOSE E AGUILAR-NASCIMENTO, MD, PhD Federal University of Mato Grosso
PRS Account Federal University of Mato Grosso
Verification Date April 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP