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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000043844
Receipt No. R000050043
Scientific Title Study of changes in the concentration of plasma amino acid by taking the functional food
Date of disclosure of the study information 2021/04/06
Last modified on 2021/04/05

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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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