UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054160 |
|---|---|
| Receipt number | R000061426 |
| Scientific Title | Comparison of gastric emptying between protein and carbohydrate solution |
| Date of disclosure of the study information | 2024/05/01 |
| Last modified on | 2025/10/16 13:40:02 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Comparison of gastric emptying between protein and carbohydrate solution
Acronym
Comparison of gastric emptying between protein and carbohydrate solution
Scientific Title
Comparison of gastric emptying between protein and carbohydrate solution
Scientific Title:Acronym
Comparison of gastric emptying between protein and carbohydrate solution
Region
| Japan |
Condition
Condition
none
Classification by specialty
| Operative medicine | Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to examine gastric emptying of protein and to determine a safe amount of protein that can be consumed preoperatively.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Gastric emptying after 120 minutes; subjects ingest 60 g protein and isocaloric carbohydrate.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
6
Purpose of intervention
Prevention
Type of intervention
| Medicine | Food |
Interventions/Control_1
protein drink 200mL (20 g protein) (112kcal) +water 400mL
Interventions/Control_2
protein drink 400mL (40 g protein) (224kcal) +water 200mL
Interventions/Control_3
protein drink 600mL (60 g protein) (336kcal)
Interventions/Control_4
50% glucose 56mL(112kcal) +water 544mL
Interventions/Control_5
50% glucose 112mL(224kcal) +water 488mL
Interventions/Control_6
50% glucose 168mL(336kcal) +water 432mL
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| 60 | years-old | >= |
Gender
Male
Key inclusion criteria
men aged 20 to 60
Key exclusion criteria
1. Patients with medical histories that affects gastric emptying
- gastrointestinal surgery
- gastric diseases
2. Obesity (BMI>30)
3. Milk or soy allergies
4. Patients with requirring carbohydrate or protein restrictions
5. Outpatients with receiving medications
6. Other persons deemed by the principal investigator or Co-investigator to be inappropriate to participate in this research
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Nobutoshi |
| Middle name | |
| Last name | Hagiwara |
Organization
Nippon Medical School
Division name
Department of Gastrointestinal and Hepato-Biliary-Pancreatic Surgery
Zip code
113-8603
Address
1-1-5, Sendagi, Bunkyo-ku, Tokyo
TEL
03-3822-2131
hagi@nms.ac.jp
Public contact
Name of contact person
| 1st name | Hiromasa |
| Middle name | |
| Last name | Komori |
Organization
Nippon Medical School
Division name
Department of Gastrointestinal and Hepato-Biliary-Pancreatic Surgery
Zip code
113-8603
Address
1-1-5, Sendagi, Bunkyo-ku, Tokyo
TEL
03-3822-2131
Homepage URL
h-komori@nms.ac.jp
Sponsor or person
Institute
Nippon Medical School
Institute
Department
Personal name
Funding Source
Organization
Nippon Medical School
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Nippon Medical School
Address
1-1-5, Sendagi, Bunkyo-ku, Tokyo
Tel
03-3822-2131
h-komori@nms.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
日本医科大学付属病院(東京都)
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 05 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
10
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
No longer recruiting
Date of protocol fixation
| 2024 | Year | 03 | Month | 04 | Day |
Date of IRB
| 2024 | Year | 03 | Month | 31 | Day |
Anticipated trial start date
| 2024 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2027 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 04 | Month | 15 | Day |
Last modified on
| 2025 | Year | 10 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000061426
