UMIN-CTR Clinical Trial

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
Email	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
Email	naoko_fujimura@ajinomoto.com

Sponsor
Institute	Medical Corporation Hokubukai Utsukushigaoka Hospital
Institute
Department

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
Email

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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034917