UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000036513
Receipt number R000041599
Scientific Title The efficacy test of oral stimuli on salivary secretion and components
Date of disclosure of the study information 2019/04/19
Last modified on 2020/04/27 10:05:20

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Basic information

Public title

The efficacy test of oral stimuli on salivary secretion and components

Acronym

The efficacy test of oral stimuli on salivary secretion and components

Scientific Title

The efficacy test of oral stimuli on salivary secretion and components

Scientific Title:Acronym

The efficacy test of oral stimuli on salivary secretion and components

Region

Japan


Condition

Condition

Healthy adults

Classification by specialty

Not applicable Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To evaluate the effects of oral stimuli on salivary secretion.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Salivary secretion and components volume

Key secondary outcomes

Salivary secretion and components rate


Base

Study type

Interventional


Study design

Basic design

Cross-over

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Placebo

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

3

Purpose of intervention

Prevention

Type of intervention

Food

Interventions/Control_1

Single ingestion of the product.
More than 24 hours washout between the ingestions.
Ingestion order: product 1, product 2, product3, product4, product5.

Interventions/Control_2

Single ingestion of the product.
More than 24 hours washout between the ingestions.
Ingestion order: product 2, product 3, product1, product5, product4.

Interventions/Control_3

Single ingestion of the product.
More than 24 hours washout between the ingestions.
Ingestion order: product 3, product 1, product2, product4, product5.

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

50 years-old >

Gender

Male

Key inclusion criteria

Healthy subjects giving written informed consent.

Key exclusion criteria

1) Subjects with a history of allergy or might be liable to allergy related to the study
2) Subjects who have serious historical disease, marked impairment, or treatment in the liver, kidney, heart, lung, gastrointestinal tract, blood, endocrine system, or metabolism system
3) Subjects with low salivary secretion.
4) Subjects deemed inappropriate to participate in this study by the principle investigator

Target sample size

20


Research contact person

Name of lead principal investigator

1st name Shinji
Middle name
Last name Yamamoto

Organization

Kao Corporation

Division name

Personal Health Care Products Research

Zip code

131-8501

Address

2-1-3, Bunka Sumida-ku Tokyo, 131-8501, JAPAN

TEL

03-5630-9416

Email

yamamoto.shinji@kao.com


Public contact

Name of contact person

1st name Kenkichi
Middle name
Last name Yamamoto

Organization

Kao Corporation

Division name

Personal Health Care Products Research

Zip code

131-8501

Address

2-1-3, Bunka Sumida-ku Tokyo, 131-8501, JAPAN

TEL

03-5630-9416

Homepage URL


Email

yamamoto.kenkichi@kao.com


Sponsor or person

Institute

Kao Corporation

Institute

Department

Personal name



Funding Source

Organization

Kao Corporation

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

Human Research Ethics Committee, Kao Corporation

Address

2-1-3, Bunka Sumida-ku Tokyo, 131-8501, JAPAN

Tel

03-5630-9786

Email

uesaka.toshio@kao.com


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

花王株式会社(東京都)


Other administrative information

Date of disclosure of the study information

2019 Year 04 Month 19 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

2019 Year 01 Month 22 Day

Date of IRB

2019 Year 01 Month 22 Day

Anticipated trial start date

2019 Year 04 Month 22 Day

Last follow-up date

2019 Year 07 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded

2020 Year 03 Month 31 Day


Other

Other related information



Management information

Registered date

2019 Year 04 Month 15 Day

Last modified on

2020 Year 04 Month 27 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041599


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name