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

Showa Inan General Hospital

Status: Completed

Conditions: Gastric Emptying

Treatments: Other: Standard semi-solid diet; Other: Elemental liquid diet

Study type: Interventional

Funder types: Other

Identifiers

NCT02587611

Gastric emptying

Details and patient eligibility

About

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.

Full 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.

Enrollment: 8 patients

Sex: All

Ages: 20 to 90 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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8 participants in 2 patient groups

Elemental liquid diet

Experimental group

Description:

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.

Treatment:

Other: Elemental liquid diet

Standard semi-solid diet

Active Comparator group

Description:

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.

Treatment:

Other: Standard semi-solid diet