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

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 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

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

Value
https://center6.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