UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000049448 |
|---|---|
| Receipt number | R000056263 |
| Scientific Title | Effect amino acid mixture on blood glucose - a randomized placebo controlled double blind cross-over study- |
| Date of disclosure of the study information | 2022/11/07 |
| Last modified on | 2023/09/27 17:35:08 |
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Basic information
Public title
Effect of amino acid mixture on blood glucose
Acronym
Effect of amino acid mixture on blood glucose
Scientific Title
Effect amino acid mixture on blood glucose - a randomized placebo controlled double blind cross-over study-
Scientific Title:Acronym
Effect amino acid mixture on blood glucose
Region
| Japan |
Condition
Condition
healthy adult
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examines the effect of amino acid mixture on blood glucose
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Blood glucose levels
Key secondary outcomes
Plasma insulin levels
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
YES
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
amino acid mixture,
single dose
Interventions/Control_2
foods not containing amino acid mixture,
single dose
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
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
(1)(Healthy) males and females aged between 20 to 64 years old.
(2)Subjects whose fasting blood glucose levels are from 100 mg/dL to 125 mg/dL, or OGTT test (after 2hours) blood glucose levels are from 140mg/dL to 199mg/dL.
(3)Not heavy alcoholic drinker. (Subjects who can stop drinking from 2 days before each measurement.)
(4) Subjects who can make self-judgment and are voluntarily giving written consent form.
Key exclusion criteria
(1)Subjects who use oral medication affecting blood glucose.
(2)Subjects who constantly use supplements and/or functional foods (including Food for Specified Health Uses) affecting blood glucose.
(3)Subjects who need medical treatment for diabetes.
(4)Subjects who contract or are under treatment or are medical history for serious diseases (e.g.,liver disease, kidney disease, and/or heart disease), thyroid gland disease, adrenal gland disease, and/or metabolic disorder.
(5)Subjects who have a operational history of digestive disease affecting digestion and absorption.
(6)Subjects who are judged as unsuitable for the study based on the results of blood tests by the investigator at screening.
(7)Subjects who have donated 400 mL of blood within 12 weeks prior to the start of the study and 200 mL of blood within 4 weeks and component blood donations (plasma component and platelet component blood donations) within 2 weeks prior to the start of the study. Also, considering the total amount of blood collected during the study, those who plan to donate blood within 12 weeks of the study.
(8)Subjects who are diagnosed as anemic and not suitable for frequent collection of blood.
(9)Subjects who developed diarrhea or took antibiotics within one week retroactive to the examination.
(10)Subjects who are planning to participate in other clinical studies.
(11)Subjects who are planning to become pregnant after informed consent for the current study or are pregnant or lactating.
(12)Subjects who are judged as unsuitable for the study by the investigator for other reasons.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Yuji |
| Middle name | |
| Last name | Suda |
Organization
Ajinomoto Co., Inc.
Division name
Healthcare Food Development Group Wellness Value Creation Center Institute of Food Sciences and Technologies
Zip code
210-8681
Address
1-1, Suzuki-cho, Kawasaki-ku, Kawasaki-shi, Kanagawa, Japan
TEL
044-223-4168
yuuji.suda.53c@asv.ajinomoto.com
Public contact
Name of contact person
| 1st name | kyoko |
| Middle name | |
| Last name | miura |
Organization
Ajinomoto Co., Inc.
Division name
Healthcare Food Development Group Wellness Value Creation Center Institute of Food Sciences and Tech
Zip code
210-8681
Address
1-1, Suzuki-cho, Kawasaki-ku, Kawasaki-shi, Kanagawa, Japan
TEL
07043255184
Homepage URL
Kyouko.miura.jt9@asv.ajinomoto.com
Sponsor or person
Institute
KSO Corporation
Institute
Department
Personal name
Funding Source
Organization
Ajinomoto Co., Inc.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
KSO Corporation
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Committee of Ajinomoto Co., Ltd
Address
1-15-1,Kyobashi, Chuo-ku, Tokyo
Tel
+81-3-5250-8134
ajinomoto_irb@ajinomoto.com
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
株式会社ケイ・エス・オー（東京都）
KSO Co., Ltd. (Tokyo)
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 11 | 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
Results
The study itself was not established, and the material could not be properly evaluated. Randomization may have failed due to large group (order of intake) differences in blood glucose concentration and delta AUC, Cmax, and delta cmax at 30-90 minutes after the loading meal.
Results date posted
| 2023 | Year | 09 | Month | 27 | Day |
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
Preinitiation
Date of protocol fixation
| 2022 | Year | 09 | Month | 22 | Day |
Date of IRB
| 2022 | Year | 09 | Month | 22 | Day |
Anticipated trial start date
| 2022 | Year | 12 | Month | 05 | Day |
Last follow-up date
| 2023 | 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
| 2022 | Year | 11 | Month | 07 | Day |
Last modified on
| 2023 | Year | 09 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000056263
| Research Plan | |
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| Registered date | File name |
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