Gastric Emptying
Conditions
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.
Interventions
OTHERElemental 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.
OTHERStandard 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.
Sponsors
Showa Inan General Hospital
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to 90 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Gastric emptying | 4 hours | 10% 30% or 50% gastric emptying (excretion) time |
Countries
Japan
Outcome results
None listed