Randomized Comparison of Elemental Liquid Diet and Standard Semi-solid Diet on Gastric Emptying

Gastric Emptying Clinical Trial

Official title:

Randomized Comparison of Elemental Liquid Diet and Standard Semi-solid Diet on Gastric Emptying in Healthy Subjects and Bedridden Gastrostomy-fed Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02587611
• Other study ID #: Gastric emptying
• Status: Completed
• Phase: N/A
• First received: October 22, 2015
• Last updated: April 28, 2017
• Start date: November 2015
• Est. completion date: April 2017

Study information

• Verified date: April 2017
• Source: Showa Inan General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to compare the effect of either elemental liquid diet or standard semi-solid diet on gastric emptying in both healthy subjects and bedridden patients receiving gastrostomy feeding.

Description:

A randomized, crossover trial using elemental liquid diet or standard semi-solid diet containing 13C sodium acetate as a tracer is performed in both healthy subjects and bedridden gastrostomy-fed patients. 13C breath tests is performed to estimate gastric emptying.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8
• Est. completion date: April 2017
• Est. primary completion date: April 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 90 Years

Eligibility

Inclusion Criteria:

• healthy subjects bedridden gastrostomy-fed patients

Exclusion Criteria:

• regular use of gastric acid blockers, motility drugs, benzodiazepines or opioids, any clinical evidence of acute infection, a history of abdominal surgery, and an American Society of Anesthesiologists physical status of class IV or V.

Related Conditions & MeSH terms

• Gastric Emptying

Intervention

Other:
• Elemental liquid diet
This is a randomized, crossover trial. Two types of test meals (200 kcal/200 mL of either the elemental diet or the semi-solid diet) are labeled with 100 mg [13C]sodium acetate and administered within 5 min in healthy subjects or within 15 min in gastrostomy-fed patients.
• Standard semi-solid diet
This is a randomized, crossover trial. Two types of test meals (200 kcal/200 mL of either the elemental diet or the semi-solid diet) are labeled with 100 mg [13C]sodium acetate and administered within 5 min in healthy subjects or within 15 min in gastrostomy-fed patients.

Locations

Country	Name	City	State
Japan	Showa Inan General Hospital	Komagane

Sponsors (1)

Lead Sponsor	Collaborator
Showa Inan General Hospital

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Gastric emptying	10% 30% or 50% gastric emptying (excretion) time	4 hours