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NCT Number: NCT02587611

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

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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Key information

Conditions

Gastric Emptying

Age range

20 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Showa Inan General Hospital

Komagane, 399-4191, Japan

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Other names: Elental®

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.

Other names: Racol NF semi-liquid®

Primary outcomes

  1. Gastric emptying

    Time frame: 4 hours

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

Sponsors and collaborators

Lead sponsor

Showa Inan General Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Oct 27, 2015
Registry last updated
May 2, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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