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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

8 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-11-30

Study Completion Date

2017-04-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Gastric Emptying

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

Elemental liquid diet

Intervention Type 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.

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.

Group Type ACTIVE_COMPARATOR

Standard semi-solid diet

Intervention Type 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.

Interventions

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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.

Intervention Type 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.

Intervention Type OTHER

Other Intervention Names

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Elental® Racol NF semi-liquid®

Eligibility Criteria

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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.

Minimum Eligible Age

20 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes