UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000038580
Receipt number R000043874
Scientific Title Absorptivity confirmation test in single ingestion of food ingredients for healthy adults
Date of disclosure of the study information 2019/11/14
Last modified on 2019/12/29 17:36:39

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Basic information

Public title

Absorbency confirmation test of food ingredients

Acronym

Absorbency confirmation test of food ingredients

Scientific Title

Absorptivity confirmation test in single ingestion of food ingredients for healthy adults

Scientific Title:Acronym

Absorptivity confirmation test in single ingestion of food ingredients for healthy adults

Region

Japan


Condition

Condition

Healthy adult

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To compare blood kinetics of food ingredients with control ingredients in healthy adult male

Basic objectives2

Pharmacokinetics

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Comparison of blood kinetics of food ingredients with control ingredients

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Cross-over

Randomization

Non-randomized

Randomization unit


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

Intake of test food (single ingestion) - washout period - control food (single ingestion)

Interventions/Control_2

Intake of control food (single ingestion) - washout period - test food (single ingestion)

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

20 years-old <=

Age-upper limit

65 years-old >

Gender

Male

Key inclusion criteria

Healthy males from 20 to under 65 years of age

Key exclusion criteria

(1) Subjects who routinely use health food containing participating component
(2) Subjects who cannot carry out inspection procedure as prescribed
(3) Subjects who have under treatment or a history of serious disease
(4) Subjects having possibilities for emerging allergy related to the test food
(5) Subjects who donated over 200mL blood or blood components within the last one month to the current study.
(6) Subjects who donated over 400mL blood within the last three months to the current study.
(7) Subjects who will be collected over 1200mL blood, when the sampling amounts within the last twelve months are adding to the planned sampling amounts of this study.
(8) Subjects who are judged as unsuitable for the current study based on the results of clinical and physical preliminary examination
(9) Subjects who have participated in other clinical studies within the last one month prior to the current study or are planned to participate in other studies after obtaining informed consent for the current study
(10) Subjects who are judged as unsuitable for the current study based on the results of lifestyle questionnaire
(11) Subjects judged as unsuitable for the current study by the investigator

Target sample size

8


Research contact person

Name of lead principal investigator

1st name Masamitsu
Middle name
Last name Moriwaki

Organization

Taiyo Kagaku Co., Ltd.

Division name

Nutrition division

Zip code

510-0844

Address

1-3, Takara-cho, Yokkaichi-shi, Mie

TEL

059-347-5411

Email

mmoriwaki@taiyokagaku.co.jp


Public contact

Name of contact person

1st name Ryo
Middle name
Last name Nakagawa

Organization

Taiyo Kagaku Co., Ltd.

Division name

Nutrition division

Zip code

510-0844

Address

1-3, Takara-cho, Yokkaichi-shi, Mie

TEL

059-347-5411

Homepage URL


Email

rnakagawa@taiyokagaku.co.jp


Sponsor or person

Institute

TTC Co., Ltd

Institute

Department

Personal name



Funding Source

Organization

Taiyo Kagaku 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

Aisei Hospital Ueno Clinic Research Ethics Committee

Address

2-18-6, Higashiueno, Taitou-ku, Tokyo

Tel

03-6455-0880

Email

t.saito@ttc-smo.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



Other administrative information

Date of disclosure of the study information

2019 Year 11 Month 14 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

8

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

2019 Year 11 Month 14 Day

Date of IRB

2019 Year 11 Month 14 Day

Anticipated trial start date

2019 Year 11 Month 15 Day

Last follow-up date

2019 Year 11 Month 29 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2019 Year 11 Month 14 Day

Last modified on

2019 Year 12 Month 29 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043874


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name