UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043844 |
|---|---|
| Receipt number | 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 18:07:59 |
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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
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
katour@uha-mikakuto.co.jp
Sponsor or person
Institute
UHA Mikakuto Co., Ltd.
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050043
