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

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

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.

Study Overview

• Status: Completed
• Conditions: Gastric Emptying
• Intervention / Treatment: Other: Elemental liquid diet; Other: Standard semi-solid diet

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 8
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Japan
  • Komagane, Japan, 399-4191
    • Showa Inan General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Elemental liquid diet; Elemental liquid diet (200 kcal/200 mL) is labeled with 100 mg [13C]sodium acetate and healthy subjects drink it within 5 min. Elemental liquid diet (200 kcal/200 mL) is labeled with 100 mg [13C]sodium acetate and is administered within 15 min using the gastrostomy tube.	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.; Other Names: Elental®
Active Comparator: Standard semi-solid diet; Standard semi-solid diet (200 kcal/200 mL) is labeled with 100 mg [13C]sodium acetate and healthy subjects drink it within 5 min. Standard semi-solid diet (200 kcal/200 mL) is labeled with 100 mg [13C]sodium acetate and is administered within 15 min using the gastrostomy tube.	Other: 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.; Other Names: Racol NF semi-liquid®

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Gastric emptying	10% 30% or 50% gastric emptying (excretion) time	4 hours

Collaborators and Investigators

• Sponsor: Showa Inan General Hospital
• Investigators: Principal Investigator: Akira Horiuchi, MD, Showa Inan General Hospital

Study record dates

Study Major Dates

• Study Start: November 1, 2015
• Primary Completion (Actual): April 1, 2017
• Study Completion (Actual): April 1, 2017

Study Registration Dates

• First Submitted: October 22, 2015
• First Submitted That Met QC Criteria: October 23, 2015
• First Posted (Estimate): October 27, 2015

Study Record Updates

• Last Update Posted (Actual): May 2, 2017
• Last Update Submitted That Met QC Criteria: April 28, 2017
• Last Verified: April 1, 2017

More Information

Terms related to this study

• Other Study ID Numbers: Gastric emptying