Unique ID issued by UMIN | UMIN000052383 |
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Receipt number | R000059801 |
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 | 2023/10/10 |
Last modified on | 2024/04/03 09:37:19 |
Effect of amino acid mixture on blood glucose
Effect of amino acid mixture on blood glucose
Effect amino acid mixture on blood glucose - a randomized placebo controlled double blind cross-over study
Effect amino acid mixture on blood glucose
Japan |
healthy adult
Not applicable | Adult |
Others
NO
To examines the effect of amino acid mixture on blood glucose
Efficacy
Confirmatory
Not applicable
blood glucose levels
Plasma insulin levels, Plasma amino acid concentrations
Interventional
Cross-over
Randomized
Individual
Double blind -all involved are blinded
Placebo
YES
NO
Institution is not considered as adjustment factor.
NO
No need to know
2
Treatment
Food |
amino acid mixture,
single dose
foods not containing amino acid mixture,
single dose
20 | years-old | <= |
65 | years-old | > |
Male and Female
(1)(Healthy) males and females aged between 20 to 64 years old.
(2)Subjects whose screening test results exclude a fasting blood glucose of at least 110 mg/dL and a glucose tolerance test (Trailan G 75 g load) of at least 140 mg/dL for 2 hours by the study investigator.
(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.
(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.
42
1st name | yoji |
Middle name | |
Last name | yamada |
Ajinomoto Co., Inc.
Funtional Ingredients Development Group Wellness Value Creation Center Institute of Food Sciences and Technologies Food Products Division
210-8681
1-1, Suzuki-cho, Kawasaki-ku, Kawasaki-shi, Kanagawa, Japan
07043255184
youji.yamada.wn9@asv.ajinomoto.com
1st name | kyoko |
Middle name | |
Last name | MIURA |
Ajinomoto Co., Inc.
Functional Ingredients Development Group Wellness Value Creation Center Institute of Food Sciences
213
1-1, Suzuki-cho, Kawasaki-ku, Kawasaki-shi, Kanagawa, Japan
07043255184
kyouko.miura.jt9@asv.ajinomoto.com
CSC Corporation
Ajinomoto Co., Inc.
Profit organization
Ethics Committee of Ajinomoto Co., Ltd
1-15-1,Kyobashi, Chuo-ku, Tokyo
+81-3-5250-8134
ajinomoto_irb@ajinomoto.com
NO
2023 | Year | 10 | Month | 10 | Day |
Unpublished
42
Completed
2023 | Year | 08 | Month | 10 | Day |
2023 | Year | 08 | Month | 10 | Day |
2023 | Year | 10 | Month | 20 | Day |
2024 | Year | 03 | Month | 31 | Day |
2024 | Year | 06 | Month | 30 | Day |
2023 | Year | 10 | Month | 03 | Day |
2024 | Year | 04 | Month | 03 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000059801
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