Identification of Changes in Gastric Volume and Content by Ultrasound Before and After Chewing Gum

NCT02852863 | Completed DMC

• 1 other identifier: CCEI-5523-2016
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 1

Brief Summary

To identify by ultrasound the possible changes in gastric volume and content after chewing gum for an hour in volunteers with complete fasting (more than 8 hours).

Conditions

Gastric Volume

Outcome Measures

Primary Outcomes (1)

• Gastric volume change in mL

  2 hours

Study Arms (1)

Ultrasound (case only)

EXPERIMENTAL

Subjects will fast for a minimum of 8 hours. Ultrasound assessment of gastric volume and content will determine basal conditions. Next, subjects will chew gum for one hour with changes of gum every 20 minutes (a total of 3 gums will be chewed per subject). Once the last gum is chewed, the gum will be disposed in the trashcan. Three more ultrasound assessments will take place: immediately after one hour of chewing gum, and at the first and second hour after chewing gum has stopped. The content will be classified as empty, with fluids, or with solid. In case of fluids, volume will be measured.

Other: Gum

Interventions

Gum OTHER

Subjects will fast for a minimum of 8 hours. A baseline ultrasound assesment will be performed to evaluate gastric content. Next, subjects will chew sugarless gum for one hour with changes of gum every 20 minutes (a total of 3 gums will be chewed per subject). Once the last gum is chewed, the gum will be disposed in the trashcan. Three more ultrasound assessments will take place: immediately after one hour of chewing gum, and at the first and second hour after chewing gum has stopped. The content will be classified as empty, with fluids, or with solid. In case of fluids, volume will be measured.

Ultrasound (case only)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• adults older or equal than 18 years old
• Minimum of 8 hours of fasting
• must work/study at Fundacion Santa Fe

You may not qualify if:

• Comorbidities such as obesity, renal failure, diabetes
• Gastrointestinal Disease

Sponsors & Collaborators

• Fundación Santa Fe de Bogota: lead

Study Sites (1)

Hospital Universitario Fundacion SantaFe de Bogota

Bogotá, Bogota D.C., Colombia

Location

MeSH Terms

Interventions

Chewing Gum

Intervention Hierarchy (Ancestors)

Plant Gums; Biopolymers; Polymers; Macromolecular Substances; Polysaccharides; Carbohydrates; Plant Exudates; Biological Products; Complex Mixtures; Candy; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: July 26, 2016
• First Posted: August 2, 2016
• Study Start: July 1, 2016
• Primary Completion: October 1, 2016
• Study Completion: October 1, 2016
• Last Updated: March 22, 2017

Record last verified: 2017-03

Data Sharing

• IPD Sharing: Will share

Locations

CO (1)