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

NCT01828645 | Completed Phase 2

• 1 other identifier: cho+whey protein safety
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Peptic Ulcer; Gastritis

Keywords

gastric emptying; whey protein; carbohydrate; fasting

Outcome Measures

Primary Outcomes (1)

• 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

  2 hours

Study Arms (2)

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.

Dietary Supplement: Carbohydrate plus whey protein enriched drink

Interventions

Carbohydrate plus whey protein enriched drink DIETARY_SUPPLEMENT

The patients will drink 200 mL of the nutritional supplement (Jucy, Fresenius Kabi, Brazil) 2h before upper digestive endoscopy under sedation with propofol.

Also known as: Jucy (Fresenius Kabi, Brazil), Study group

Intervention

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Federal University of Mato Grosso: lead

Study Sites (1)

Gastroclinica

Cuiabá, Mato Grosso, 78048-150, Brazil

Location

Related Publications (1)

• 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.

  PMID: 21668975 BACKGROUND

MeSH Terms

Conditions

Peptic Ulcer; Gastritis; Fasting

Interventions

Carbohydrates

Condition Hierarchy (Ancestors)

Duodenal Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Stomach Diseases; Gastroenteritis; Feeding Behavior; Behavior

Study Officials

• JOSE E AGUILAR-NASCIMENTO, MD, PhD

  Federal University of Mato Grosso

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 8, 2013
• First Posted: April 10, 2013
• Study Start: February 1, 2013
• Primary Completion: March 1, 2013
• Study Completion: March 1, 2013
• Last Updated: April 10, 2013

Record last verified: 2013-04

Locations

BR (1)