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

NCT02587611 | Completed

• 1 other identifier: Gastric emptying
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

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.

Conditions

Gastric Emptying

Outcome Measures

Primary Outcomes (1)

• Gastric emptying

  10% 30% or 50% gastric emptying (excretion) time

  4 hours

Study Arms (2)

Elemental liquid diet

EXPERIMENTAL

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

Standard semi-solid diet

ACTIVE COMPARATOR

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

Interventions

Elemental liquid diet OTHER

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.

Also known as: Elental®

Elemental liquid diet

Standard semi-solid diet OTHER

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.

Also known as: Racol NF semi-liquid®

Standard semi-solid diet

Eligibility Criteria

• Age: 20 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• healthy subjects bedridden gastrostomy-fed patients

You may not qualify if:

• 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.

Sponsors & Collaborators

• Showa Inan General Hospital: lead

Study Sites (1)

Showa Inan General Hospital

Komagane, 399-4191, Japan

Location

Study Officials

• Akira Horiuchi, MD

  Showa Inan General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief

Study Record Dates

• First Submitted: October 22, 2015
• First Posted: October 27, 2015
• Study Start: November 1, 2015
• Primary Completion: April 1, 2017
• Study Completion: April 1, 2017
• Last Updated: May 2, 2017

Record last verified: 2017-04

Locations

JP (1)