UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000039301
Receipt number R000044825
Scientific Title Study of changes in blood amino acid concentration by ingestion of test food
Date of disclosure of the study information 2020/02/26
Last modified on 2021/01/05 16:56:53

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Basic information

Public title

Study of changes in blood amino acid concentration by ingestion of test food

Acronym

Study of changes in blood amino acid concentration by ingestion of test food

Scientific Title

Study of changes in blood amino acid concentration by ingestion of test food

Scientific Title:Acronym

Study of changes in blood amino acid concentration by ingestion of test food

Region

Japan


Condition

Condition

None

Classification by specialty

Not applicable Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Study of changes in blood amino acid concentration over time by ingestion of test food

Basic objectives2

Others

Basic objectives -Others

Absorption kinetics after food ingestion

Trial characteristics_1

Exploratory

Trial characteristics_2


Developmental phase

Not applicable


Assessment

Primary outcomes

Plasma amino acids concentration

Key secondary outcomes

plasma glucose and insulin concentration


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

5

Purpose of intervention

Prevention

Type of intervention

Food

Interventions/Control_1

Ingestion of study foodA substance (Once).

Interventions/Control_2

Ingestion of study foodB substance (Once).

Interventions/Control_3

Ingestion of study foodC substance (Once).

Interventions/Control_4

Ingestion of study foodD substance (Once).

Interventions/Control_5

Ingestion of study foodE substance (Once).

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

60 years-old >

Gender

Male and Female

Key inclusion criteria

1) Japanese individuals aged 20-60 years.
2) Individuals who are healthy and are not suffered from a chronic malady.
3) Individuals whose written informed consent has been obtained.
4) Individuals who can visit an inspection facility and be inspected in designated days.
5) Individuals judged appropriate for the study by the principal.
6) Individuals who are not resistant to blood sampling.

Key exclusion criteria

1)Individuals using medical products.
2)Individuals who have a history of serious hepatopathy, kidney damage, heart disease, lung and blood disease.
3)Individuals who contract or have a history of serious gastrointestinal disease.
4)Individuals who have an addiction to alcohol or a mental illness.
5)Individuals who used or applied a drug for treatment of disease in the past 1 month.
6)Individuals with probable seasonal allergy, such as pollinosis, during the test period.(In particular, Betulaceae: alder, oba alnus firma, shirakaba, Taxodiaceae: cryptomeria, hinoki cypress, Asteraceae: ragweed, Artemisia vulgaris indica, Gramineae:Dactylis glomerata, Phleum pratense)
7)Individuals who have possibility of allergy symptoms onset by the test food and who cause severe allergic symptoms in foods and medicines.
8)Individuals cannnot drink milk or dairy products.
9)Individuals with serious anemia.
10)Individuals with high blood glucose(fasting blood glucose over 126mg/dL).
11)Individuals who are a smoker.
12)Females who are or are possibly pregnant, or are lactating.
13)Individuals whose life style will change during the test period.
14)Individuals who had a habit to ingest health-promoting foods, foods for specified health uses, health foods, or supplements in the past 3 months or will ingest those foods during the test period.
15)Individuals who were hospitalized and received treatment in the past 6 months.
16)Individuals who participated in other clinical studies in the past 1 months or will participate in other clinical studies during the test period.
17)Individuals judged inappropriate for the study by the principal.

Target sample size

12


Research contact person

Name of lead principal investigator

1st name Hiroko
Middle name
Last name Uchida

Organization

MORINAGA & CO., LTD.

Division name

Health Science and Research Center, R&D institute

Zip code

230-8504

Address

2-1-1, Shimodueyoshi, Tsurumi-ku, Yokohama

TEL

045-571-6140

Email

h-uchida-ji@morinaga.co.jp


Public contact

Name of contact person

1st name Takayuki
Middle name
Last name Yamamoto

Organization

MORINAGA & CO., LTD.

Division name

Health Science and Research Center, R&D institute

Zip code

230-8504

Address

2-1-1, Shimodueyoshi, Tsurumi-ku, Yokohama

TEL

045-571-6140

Homepage URL


Email

t-yamamoto-jc@morinaga.co.jp


Sponsor or person

Institute

MORINAGA & CO., LTD.

Institute

Department

Personal name



Funding Source

Organization

MORINAGA & 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

Japan Conference of Clinical Research

Address

1-13-23 Minamiikebukuro, Toshima-ku, Tokyo

Tel

03-6868-7022

Email

None


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



Other administrative information

Date of disclosure of the study information

2020 Year 02 Month 26 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

2020 Year 01 Month 07 Day

Date of IRB

2020 Year 01 Month 16 Day

Anticipated trial start date

2020 Year 01 Month 17 Day

Last follow-up date

2020 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

2020 Year 01 Month 29 Day

Last modified on

2021 Year 01 Month 05 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044825


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name