NCT01798342

Brief Summary

Carbohydrates (CHO)-based drinks 2h before the induction of anesthesia are recommended to decrease insulin resistance. The addition of glutamine (GLN) in these beverages may enhance the benefits of CHO alone. However, only a few studies tested the safety of this formula. The objective of this study was to evaluate the gastric residual volume (GRV) after the intake of a beverage containing CHO plus GLN using magnetic resonance (MRI).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
11

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Mar 2012

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2012

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2012

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2012

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

February 19, 2013

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 25, 2013

Completed
Last Updated

February 25, 2013

Status Verified

February 1, 2013

Enrollment Period

3 months

First QC Date

February 19, 2013

Last Update Submit

February 22, 2013

Conditions

Pulmonary Aspiration of Gastric ContentsAdverse Effects in the Therapeutic Use of Other and Unspecified General AnaestheticsPulmonary Aspiration During Anaesthetic Induction

Keywords

preoperative caremaltodextrineglutaminegastric residual volumeMRI

Outcome Measures

Primary Outcomes (1)

  • Gastric residual volume (GVR) ("change" is being assessed)

    We measured the GRV by MRI immediately after ingestion (T0)and the changes of GVR after 120 (T120)and 180 minutes (T180)- "change" is being assessed

    immediately after ingestion (T0), 120 minutes after (T120) and 180 (T180) minutes after ingestion

Secondary Outcomes (1)

  • Vomiting

    180 minutes

Study Arms (2)

Maltodextrin

ACTIVE COMPARATOR

The volunteers ingested 400ml (4 hours before the exam was carried out) at 8:00AM and 200ml (2 hours before the exam was carried out) at 10:00AM of a beverage containing water plus 12.5% maltodextrin

Dietary Supplement: Maltodextrin

Glutamine

EXPERIMENTAL

The same volunteers ingested 400ml (4 hours before the exam was carried out) at 8:00AM and 200ml (2 hours before the exam was carried out) at 10:00AM of a beverage containing water plus 12.5% maltodextrin plus 15g of glutamine

Dietary Supplement: Glutamine

Interventions

MaltodextrinDIETARY_SUPPLEMENT

The volunteers underwent MRI after the ingestion of the dietary supplement in a crossover fashion aiming at measuring the gastric residual volume

Also known as: Maltodestrin plus glutamine
Maltodextrin
GlutamineDIETARY_SUPPLEMENT

The volunteers ingested 400ml (4 hours before the exam was carried out) at 8:00AM and 200ml (2 hours before the exam was carried out) at 10:00AM of a beverage containing water plus 12.5% maltodextrin plus 15g of GLN before MRI

Glutamine

Eligibility Criteria

Age21 Years - 30 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Young male volunteers (aged between 21 and 30 years-old) with body mass index (BMI) between 20 and 29 kg/m2 and without either acute or chronic illness in the last 3 months.

You may not qualify if:

  • non-adherence to any phase of the study protocol,
  • gastroesophageal reflux disease,
  • previous history of intolerance to lactose,
  • gastroparesis or history of poor gastric emptying,
  • diabetes mellitus, and
  • previous abdominal surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Santa Rosa

Cuiabá, Mato Grosso, 78000-000, Brazil

Location

MeSH Terms

Conditions

Respiratory Aspiration of Gastric Contents

Interventions

maltodextrinGlutamine

Condition Hierarchy (Ancestors)

Laryngopharyngeal RefluxGastroesophageal RefluxEsophageal Motility DisordersDeglutition DisordersEsophageal DiseasesGastrointestinal DiseasesDigestive System DiseasesRespiratory AspirationRespiration DisordersRespiratory Tract DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Amino Acids, BasicAmino AcidsAmino Acids, Peptides, and ProteinsAmino Acids, DiaminoAmino Acids, Neutral

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

February 19, 2013

First Posted

February 25, 2013

Study Start

March 1, 2012

Primary Completion

June 1, 2012

Study Completion

July 1, 2012

Last Updated

February 25, 2013

Record last verified: 2013-02

Locations

BR(1)