UMIN-CTR Clinical Trial

Basic information
Public title	Study of changes in the concentration of plasma amino acid by taking the functional food
Acronym	Study of changes in the concentration of plasma amino acid by taking the functional food
Scientific Title	Study of changes in the concentration of plasma amino acid by taking the functional food
Scientific Title:Acronym	Study of changes in the concentration of plasma amino acid by taking the functional food
Region	Japan

Condition
Condition	Healthy adults
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To verify the effect of functional food on the changes of the plasma amino acid concentration
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase	Not applicable

Assessment
Primary outcomes	Plasma amino acid
Key secondary outcomes	Plasma ketone bodies, TP, ALB, AST, ALT, gamma-GTP, ALP, CRE, UA, T-Cho, HDL, LDL, TG, GLU, CK, CK isozyme

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	Prevention
Type of intervention	Food
Interventions/Control_1	Functional food
Interventions/Control_2	Placebo
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	40 years-old <=
Age-upper limit	60 years-old >
Gender	Male
Key inclusion criteria	1)Healthy males aged 40-59 years old 2)BMI 18.5-25 3)Having a habit of light exercise
Key exclusion criteria	1)Milk, soybean, egg, apple, orange, peach allergy 2)Regularly use excessive alcohol and tobacco 3)Extremely irregular diet 4)Taking ingest foods for specified health use, foods with functional claims, and other foods and beverages with possible functionalities 5)Taking more than 20g/day protein besides meals 6)Using the gym more than 1 time/week 7)Feeling sense of resistance against collecting blood 8)Having experiences of trouble about collecting blood 9)Willing to become pregnant during pregnancy, breastfeeding, or during the study period 10)Participated in other clinical trials or plan to participate during this research period 11)Lactose intolerance 12)Showing abnormal data in the plasma amino acid fraction 13)Diagnosed with some kind of illness and are being treated or taking medication 14)Serious illness 15)Persons who will not be judged suitable to the participants by the investigator.
Target sample size	30

Research contact person
Name of lead principal investigator	1st name Rina Middle name Last name Kato
Organization	UHA Mikakuto Co., Ltd.
Division name	Global Healthcare Research Laboratory
Zip code	540-0016
Address	4-12, Kanzaki-cho, Osaka-shi, Osaka
TEL	06-6767-6050
Email	katour@uha-mikakuto.co.jp

Public contact
Name of contact person	1st name Rina Middle name Last name Kato
Organization	UHA Mikakuto Co., Ltd.
Division name	Global Healthcare Research Laboratory
Zip code	540-0016
Address	4-12, Kanzaki-cho, Osaka-shi, Osaka
TEL	06-6767-6050
Homepage URL
Email	katour@uha-mikakuto.co.jp

Sponsor
Institute	UHA Mikakuto Co., Ltd.
Institute
Department

Funding Source
Organization	UHA Mikakuto 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	User Life Science Co., Ltd.
Address	372-3, Niho, Izuka-shi, Fukuoka
Tel	0948-82-3123
Email	ohnuki@fuk.kindai.ac.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	医療法人近藤クリニック　(大阪府)

Other administrative information
Date of disclosure of the study information	2021 Year 04 Month 06 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	Preinitiation
Date of protocol fixation	2021 Year 03 Month 25 Day
Date of IRB	2019 Year 09 Month 01 Day
Anticipated trial start date	2021 Year 04 Month 06 Day
Last follow-up date	2022 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	2021 Year 04 Month 05 Day
Last modified on	2021 Year 04 Month 05 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050043

Research Plan
Registered date	File name

Research case data specifications
Registered date	File name

Research case data
Registered date	File name

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