Residual Gastric Volume After the Ingestion of Supplements Containing Carbohydrates and Whey Protein

NCT05573854 | Completed

• 1 other identifier: 51807421.6.0000.5692
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief Summary

Oral supplements (OS) containing carbohydrates are being used 2h before anesthesia. The addition of a nitrogen source would improve these drinks designed for the abbreviation of preoperative fasting. The gastric emptying of an oral supplement containing whey protein in addition to carbohydrates was investigated. This is a randomized crossover study including six healthy young volunteers who were submitted to abdominal MRI in 3 phases: 1) after a overnight fast, 2) after drank 200 mL of an OS containing whey protein and carbohydrates (no lipids), and 3) 3h after ingestion of the mentioned OS. The gastric residual volume (GRV) will be evaluate by MRI. The overall findings would allow us to conclude whether the GRV, assessed by MRI, in healthy young volunteers after three hours of the ingestion of 200 ml of an oral supplement containing carbohydrates associated with whey proteins is similar to the GRV found after an overnight fast. This pilot study will add important information to allow future randomized trials including an arm with patients undergoing elective surgical procedures with a 3h fasting after the ingestion of an OS containing whey protein and carbohydrates.

Conditions

Fasting; Gastric Stasis; Perioperative Complication; Safety Issues

Keywords

Preoperative care; Preoperative fasting; Whey protein; Gastric residual volume; Oral nutritional supplement

Outcome Measures

Primary Outcomes (1)

• Gastric Residual Volume

  Gastric residual Volume in cmˆ3 assessed by MRI 3h after ingestion of the OS

  3 hours

Study Arms (3)

Overnight Fast

SHAM COMPARATOR

After an overnight fast period of eight hours, the 6 participants will attend the Radiology Service of the Hospital de Câncer, Cuiaba, Brazil to perform MRI images of the upper abdomen with the objective of measuring the fasting GRV. GRV will be evaluated by tracking the region of interest (ROI) in each slice, forming a volume by the sum of all ROIs (phase 1).

Dietary Supplement: Overnight Fast

Oral Supplement

ACTIVE COMPARATOR

Each of the 6 participants while still inside the MRI exam room just after the MRI in fast condition, will ingest 200mL of the study oral supplement (OS). The individual will be immediately positioned in the supine position and another MRI scan will be carried out. In this second phase, GRV will be evaluated again as in phase 1 (phase 2).

Dietary Supplement: Gastric emptying after an oral supplement containing carbohydrates and whey protein

3h after ingestion

ACTIVE COMPARATOR

Finally, phase 3 will be performed after a 3-hour pause. All volunteers, while still in the Radiology Service and fasted after the ingestion of the OS described in phase 2, will be submitted to a third MRI scan of the upper abdomen to measure again the GRV as previously described.

Dietary Supplement: Gastric emptying after an oral supplement containing carbohydrates and whey protein

Interventions

Gastric emptying after an oral supplement containing carbohydrates and whey protein DIETARY_SUPPLEMENT

Ingestion of an oral supplement containing carbohydrates and whey protein

3h after ingestion; Oral Supplement

Overnight Fast DIETARY_SUPPLEMENT

Residual Gastric Volume assessed by MRI after overnight fast (8h)

Overnight Fast

Eligibility Criteria

• Age: 18 Years - 30 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Male
• Young
• Healthy volunteers

You may not qualify if:

• Gastroparesis
• Any gastrointestinal condition,
• Any chronic disease,
• Alcohol or any drug ingestion the day before of the MRI study
• Not completion of the 3 phases of the study protocol

Sponsors & Collaborators

• Federal University of Mato Grosso: lead
• Univag Centro Universitário: collaborator

Study Sites (1)

Centro Universitário de Varzea Grande (UNIVAG)

Várzea Grande, Mato Grosso, 78.118-000, Brazil

Location

Related Publications (4)

• de Aguilar-Nascimento JE, Caporossi C, Metelo JS, Tanajura GH, Canevari-de-Oliveira M, da Cunha Costa R. Safe intake of an oral supplement containing carbohydrates and whey protein shortly before sedation to gastroscopy; a double blind, randomized trial. Nutr Hosp. 2014 Mar 1;29(3):681-6. doi: 10.3305/nh.2014.29.3.7161.

  PMID: 24559015 BACKGROUND

• 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

• Pimenta GP, de Aguilar-Nascimento JE. Prolonged preoperative fasting in elective surgical patients: why should we reduce it? Nutr Clin Pract. 2014 Feb;29(1):22-8. doi: 10.1177/0884533613514277. Epub 2013 Dec 11.

  PMID: 24336400 BACKGROUND

• Nogueira PLB, da Silva MR, Dock-Nascimento DB, de Aguilar-Nascimento JE. Residual gastric volume after 3 h of the ingestion of an oral supplement containing carbohydrates alone or associated with whey protein: a randomized crossover pilot study. Perioper Med (Lond). 2022 Dec 27;11(1):56. doi: 10.1186/s13741-022-00289-6.

  PMID: 36575506 DERIVED

MeSH Terms

Conditions

Fasting; Gastroparesis

Interventions

Whey Proteins

Condition Hierarchy (Ancestors)

Feeding Behavior; Behavior; Stomach Diseases; Gastrointestinal Diseases; Digestive System Diseases; Paralysis; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Milk Proteins; Animal Proteins, Dietary; Dietary Proteins; Proteins; Amino Acids, Peptides, and Proteins; Whey; Milk; Dairy Products; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Jose E Aguilar-Nascimento, MD, PhD

  Univag Centro Universitário

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Investigator will not participate of the 3 MRI sessions. Outcome Assessor will receive the data for statistical analysis blinded
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: The data will be collected in three phases. Firstly, after a fasting period of eight hours, the participants will attend the Radiology Service of the Hospital de Cancer, Cuiaba, Brazil to perform MRI images of the upper abdomen with the objective of measuring the fasting GRV (phase 1). In this phase, adequate stomach motility will be observed to exclude cases of possible gastroparesis. GRV (cmˆ3) will be measured in the fasting state by MRI tracking the region of interest (ROI) in each slice, forming a volume by the sum of all ROIs. In phase 2, each participant while still inside the MRI exam room will ingest 200 mL of the study drink described below. The individual will be immediately positioned in the supine position and another MRI scan will be carried out. Finally, phase 3 will be performed after a 3-hour pause and a third MRI scan will be done to measure again the GRV.

Study Record Dates

• First Submitted: June 26, 2022
• First Posted: October 10, 2022
• Study Start: April 1, 2022
• Primary Completion: May 30, 2022
• Study Completion: May 30, 2022
• Last Updated: October 10, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, CSR
• Time Frame: As soon as study is registered
• Access Criteria: email

Locations

BR (1)