UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000030579 |
|---|---|
| Receipt number | R000034917 |
| Scientific Title | Effect of amino acid on blood glucose level when carbohydrate ingestion |
| Date of disclosure of the study information | 2023/01/01 |
| Last modified on | 2020/06/26 15:57:32 |
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Basic information
Public title
Effect of amino acid on blood glucose level when carbohydrate ingestion
Acronym
Effect of amino acid on blood glucose level when carbohydrate ingestion
Scientific Title
Effect of amino acid on blood glucose level when carbohydrate ingestion
Scientific Title:Acronym
Effect of amino acid on blood glucose level when carbohydrate ingestion
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To study the effect of amino acids on blood glucose level after carbohydrate ingestion
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Blood glucose level
Key secondary outcomes
Blood insulin level
Blood glucagon level
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
2
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Blood collection at 0, 15, 30, 45, 60, 90, 120, 180 minutes after ingestion of prescribed amount of carbohydrates and amino acids.
Interventions/Control_2
Blood collection at 0, 15, 30, 45, 60, 90, 120, 180 minute after ingestion of placebo (prescribed amount of carbohydrates).
Interventions/Control_3
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
| 40 | years-old | > |
Gender
Male
Key inclusion criteria
1) A healthy Japanese man aged from 20 to 39 years old at the time of informed consent.
2) A person whose BMI is >= 18.5 (kg / m2) and < 25.0 (kg / m2).
3) A person who does not have regular exercise habits. His daily physical activity levels correspond to [Low (1)] or [Normal (2)] .
4) A person who can come to the scheduled date of exam..
5) A person who provided informed consent by a document.
Key exclusion criteria
1) A person with serious medical history and surgical obstacles.
2) A person who has medical disorders in heart, liver, kidney, etc. being treated during screening (including cases of complications of other diseases).
3) A person who currently has a history of gastrointestinal disorders, or who has a history of digestive surgery with problems with digestive absorption.
4) A person who is evaluated as diabetes or borderline at the time of screening (according to the criteria specified in the Diabetes Treatment Guide 2016 - 2017. Japan Diabetes Association).
5) A person who donated more than 200 mL as component donation or whole blood from 4 weeks before the start of the study until the start of the study. A person who donated 400 mL of whole blood from 4 months before the start of the test, whose blood collection amount over 1200mL within 12 months when add the planned total blood collection amount of this study.
6) A person who has participated in other clinical study and monitor test or are planned to participate in other clinical study.
7) A person who drinks alcohol over 60g/day or smokes cigarets.
8) A person who does not eat meals regularly. A person who is not a shift worker.
9) A person who regularly uses medicines, specified health foods, functional foods, health foods etc.
10) A person who got sick by blood collection in the past.
11) A person who has difficulty in blood collection because blood vessels are hard to see.
12) A person who is judged to be inappropriate for current study based on the medical chart by medical doctor.
Target sample size
13
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yasufumi Furuhata |
Organization
Ajinomoto Co., Inc.
Division name
Human Health & Nutrition Group Institute of Food Sciences & Technologies
Zip code
Address
1-1, Suzuki-tyo, Kawasaki-ku, Kawasaki-shi, Kanagawa
TEL
044-223-4114
yasufumi_furuhata@ajinomoto.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Naoko Fujimura |
Organization
Ajinomoto Co., Inc.
Division name
Human Health & Nutrition Group Institute of Food Sciences & Technologies
Zip code
Address
1-1, Suzuki-tyo, Kawasaki-ku, Kawasaki-shi, Kanagawa
TEL
044-223-4114
Homepage URL
naoko_fujimura@ajinomoto.com
Sponsor or person
Institute
Medical Corporation Hokubukai Utsukushigaoka Hospital
Institute
Department
Personal name
Funding Source
Organization
Ajinomoto Co., Inc.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
医療法人 北武会 美しが丘病院（北海道）
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 01 | 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
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
| 2017 | Year | 12 | Month | 21 | Day |
Date of IRB
| 2017 | Year | 12 | Month | 19 | Day |
Anticipated trial start date
| 2018 | Year | 01 | Month | 15 | Day |
Last follow-up date
| 2018 | Year | 02 | Month | 16 | Day |
Date of closure to data entry
| 2018 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2018 | Year | 04 | Month | 09 | Day |
Date analysis concluded
| 2018 | Year | 09 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2017 | Year | 12 | Month | 26 | Day |
Last modified on
| 2020 | Year | 06 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000034917
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