UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000049118 |
|---|---|
| Receipt number | R000055849 |
| Scientific Title | Evaluation of protein absorption after ingesting an enteral diet |
| Date of disclosure of the study information | 2022/10/07 |
| Last modified on | 2023/08/17 16:43:41 |
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Basic information
Public title
Evaluation of protein absorption after ingesting an enteral diet
Acronym
Evaluation of protein absorption after ingesting an enteral diet
Scientific Title
Evaluation of protein absorption after ingesting an enteral diet
Scientific Title:Acronym
Evaluation of protein absorption after ingesting an enteral diet
Region
| Japan |
Condition
Condition
Healthy male adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to compare the pharmacokinetics of the factors, which are related to protein digestion and absorption (e.g., total amino acids), after oral ingesting an enteral diet A, B, or C under a fasting condition, up to 120 minutes in healthy young men.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
AUC and deltaAUC of total amino acids
Key secondary outcomes
1. AUC, Tmax, Cmax, deltaAUC, and deltaCmax of blood-glucose level
2. AUC, Tmax, Cmax, deltaAUC, and deltaCmax of insulin level in blood
3. AUC, Tmax, Cmax, deltaAUC, and deltaCmax of each amino acid in blood
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Oral ingestion of the enteral diet A (300 mL) once to the subjects.
Interventions/Control_2
Oral ingestion of the enteral diet B (300 mL) once to the subjects.
Interventions/Control_3
Oral ingestion of the enteral diet C (300 mL) once to the subjects.
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| 35 | years-old | > |
Gender
Male
Key inclusion criteria
1) Male subjects ranging in age from 20 to 34 at informed consent.
2) Subjects who can give informed consent to partake in this study after being provided with an explanation of the experimental protocol detail.
3) Subjects ranging in BMI from not less than 18.5 but less than 25.0 kg/m2.
Key exclusion criteria
(1) Subjects taking steadily (not less than three times a week) in the following affecting foods; health-specific, functional, and health foods (mainly amino acids), with any difficulty in refraining from having those after the consent.
(2) Subjects taking medicine steadily, owing to some kind of disease.
(3) Subjects with current and/or previous medical history of serious diseases in heart, liver, kidney and/or digestive organs.
4) Subjects with drug/alcohol/food allergy.
5) Subjects being under another clinical research with some kind of medicine or health food, or who partook in that within four weeks before this study, or planning to take part in other clinical researches after giving informed consent to participate in this study.
(6) Subjects who donated a 200 mL of their whole blood and/or blood components within a month before this study.
(7) Subjects who donated a 400 mL of their whole blood within the last three months to this study.
(8) Subjects who will be collected over 1200 mL in total of their blood within the last twelve months, after adding the blood amounts planning to be sampled in this study.
9) At a point of the screening test, subjects having some kind of infection.
10) Others who have been determined as ineligible for participation in this study, judging from the principal/sub investigator.
Target sample size
16
Research contact person
Name of lead principal investigator
| 1st name | Shukuko |
| Middle name | |
| Last name | Ebihara |
Organization
Chiyoda Paramedical Care Clinic
Division name
Director
Zip code
103-0021
Address
2F Daiwa Building, 3-3-10 Nihonbashi-Hongoku-Cho, Chuo-ku, Tokyo 103-0021, Japan
TEL
03-6225-9005
cpcc-contact@cpcc.co.jp
Public contact
Name of contact person
| 1st name | Makoto |
| Middle name | |
| Last name | Ichinohe |
Organization
CPCC Company Limited
Division name
Clinical Planning Department
Zip code
103-0021
Address
4F Daiwa Building, 3-3-10 Nihonbashi-Hongoku-Cho, Chuo-ku, Tokyo 103-0021, Japan
TEL
03-6225-9001
Homepage URL
cpcc-contact@cpcc.co.jp
Sponsor or person
Institute
CPCC Company Limited
Institute
Department
Personal name
Funding Source
Organization
Meiji Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Institutional Review Board of Chiyoda Paramedical Care Clinic
Address
2F Daiwa Building, 3-3-10 Nihonbashi-Hongoku-Cho, Chuo-ku, Tokyo 103-0021, Japan
Tel
03-6225-9005
IRB@cpcc.co.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
チヨダパラメディカルケアクリニック
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 10 | Month | 07 | 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
16
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
Completed
Date of protocol fixation
| 2022 | Year | 09 | Month | 02 | Day |
Date of IRB
| 2022 | Year | 08 | Month | 19 | Day |
Anticipated trial start date
| 2022 | Year | 10 | Month | 07 | Day |
Last follow-up date
| 2022 | Year | 11 | Month | 18 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2022 | Year | 10 | Month | 04 | Day |
Last modified on
| 2023 | Year | 08 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055849
