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

Not Applicable

Completed

• Conditions: Gastric Emptying
• Interventions: Other: Standard semi-solid diet; Other: Elemental liquid diet

• Registration Number: NCT02587611
• Lead Sponsor: Showa Inan General Hospital

Brief 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.

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 Timeline

• Study First Submitted: 2015-10-22
• Study First Submitted QC: 2015-10-23
• Study First Posted: 2015-10-27
• Study Start: 2015-11
• Status Verified: 2017-04
• Primary Completion: 2017-04
• Study Completion: 2017-04
• Last Update Submitted: 2017-04-28
• Last Update Posted: 2017-05-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 8

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Standard semi-solid diet	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.
Elemental liquid diet	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.

Primary Outcome Measures

Name	Time	Method
Gastric emptying	4 hours	10% 30% or 50% gastric emptying (excretion) time

Trial Locations

Locations (1)

Showa Inan General Hospital; 🇯🇵 Komagane, Japan