Safety of Gastric Volume Emptying After the Intake of Maltodextrin and Glutamine
|ClinicalTrials.gov Identifier: NCT01798342|
Recruitment Status : Completed
First Posted : February 25, 2013
Last Update Posted : February 25, 2013
|Condition or disease||Intervention/treatment||Phase|
|Pulmonary Aspiration of Gastric Contents Adverse Effects in the Therapeutic Use of Other and Unspecified General Anaesthetics Pulmonary Aspiration During Anaesthetic Induction||Dietary Supplement: Maltodextrin Dietary Supplement: Glutamine||Phase 2|
We included 11 male young 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. The criteria for exclusion were 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.
Each volunteer was randomized for participation in the study in a blind fashion. All subjects underwent two different protocols before MRI with an interval of seven days between them. Both phases took place after an overnight fast of eight hours. 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 either water plus 12.5% maltodextrin (Phloraceae, Cuiabá, Brazil; CHO group) or the same beverage plus 15g of GLN (Phloraceae, Cuiabá, Brazil; GLN group). The participants were instructed not to ingest alcohol, medication, and caffeine within 24 hours of the study, nor do any vigorous physical activity during that time.
In both phases the individuals were blind to the specific drink and they were told to ingest the beverage in a maximum period of five minutes and T0 was defined as the moment they complete the intake of the solution.The powdered products (maltodextrin alone or maltodextrine plus glutamine) were packed in coded opaque sachets and the content was only known by the pharmacist who manipulated it.
All the participants in the study underwent magnetic resonance of the upper abdomen at 12:00AM and 01:00PM. The GRV observed during the first exam was defined as T120 and the second exam as T180. All exams were performed by the same magnetic resonance equipment (Intera 1.5T ; Philips Healthcare, Eindhoven, Holland).
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||11 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Official Title:||Gastric Residual Volume After He Intake Of Maltodextrin And Glutamine. A Randomized Double-Blind, Crossover Study|
|Study Start Date :||March 2012|
|Actual Primary Completion Date :||June 2012|
|Actual Study Completion Date :||July 2012|
Active Comparator: Maltodextrin
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
The volunteers underwent MRI after the ingestion of the dietary supplement in a crossover fashion aiming at measuring the gastric residual volume
Other Name: Maltodestrin plus glutamine
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
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
- Gastric residual volume (GVR) ("change" is being assessed) [ Time Frame: immediately after ingestion (T0), 120 minutes after (T120) and 180 (T180) minutes after ingestion ]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
- Vomiting [ Time Frame: 180 minutes ]We observed whether the volunteer presented vomiting during the experiment
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01798342
|Hospital Santa Rosa|
|Cuiaba, Mato Grosso, Brazil, 78000-000|