UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000030001
Receipt number R000034260
Scientific Title Verification of the sialagogic effect in food
Date of disclosure of the study information 2019/04/01
Last modified on 2019/11/21 17:52:24

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Basic information

Public title

Verification of the sialagogic effect in food

Acronym

Verification of the sialagogic effect in food

Scientific Title

Verification of the sialagogic effect in food

Scientific Title:Acronym

Verification of the sialagogic effect in food

Region

Japan


Condition

Condition

healthy humans

Classification by specialty

Not applicable Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

The effect of test food on saliva secretion in healthy adults

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable


Assessment

Primary outcomes

Blood flow in salivary gland (NIRS)
Amount of saliva secretion

Key secondary outcomes

Biochemical analysis (saliva)
alpha-Amylase
Hemoglobin
LDH
sIgA
Lysozyme
Bacteria test


Base

Study type

Interventional


Study design

Basic design

Parallel

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

6

Purpose of intervention

Prevention

Type of intervention

Food

Interventions/Control_1

1. Single oral ingestion of the water (10-20ml)

2. Intake of the water (500ml/day) for 2 weeks

Interventions/Control_2

Single oral ingestion of the test food A (10-20ml)

Interventions/Control_3

Single oral ingestion of the test food B (10-20ml)

Interventions/Control_4

1. Single oral ingestion of the test food C (10-20ml)

2. Intake of test food C (under 30ml
/day) for 2 weeks

Interventions/Control_5

Single oral ingestion of the test food C+D (10-20ml)

Interventions/Control_6

1. Single oral ingestion of the test food D (10-20g)

2. Intake of test food D (under 30g/day) for 2 weeks

Interventions/Control_7


Interventions/Control_8


Interventions/Control_9


Interventions/Control_10



Eligibility

Age-lower limit

20 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

(1) 20< of healthy men and women
(2) Who gave the informed consents in writing after receiving enough explanation of purpose and detail of the study, understanding the study well, and deciding to attend the study with their own will.

Key exclusion criteria

(1) Subjects who has treatment with warfarin.
(2) Subjects with the severe disease medical history.
(3) Subjects who are judged as inappropriate to be enrolled in this trials by chief investigator or sub investigators

Target sample size

60


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Tadayuki Iida

Organization

Prefectural University of Hiroshima.

Division name

Department of Physical Therapy, Faculty of Health and Welfare

Zip code


Address

1-1 Gakuen-cho, Mihara City, Hiroshima Pref. 723-0053, Japan

TEL

0848-60-1120

Email

iida@pu-hiroshima.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Tadayuki Iida

Organization

Prefectural University of Hiroshima.

Division name

Department of Physical Therapy, Faculty of Health and Welfare

Zip code


Address

1-1 Gakuen-cho, Mihara City, Hiroshima Pref. 723-0053, Japan

TEL

0848-60-1120

Homepage URL


Email

iida@pu-hiroshima.ac.jp


Sponsor or person

Institute

Prefectural University of Hiroshima.

Institute

Department

Personal name



Funding Source

Organization

Prefectural University of Hiroshima.

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor

SAPPORO HOLDINGS LTD.

Name of secondary funder(s)



IRB Contact (For public release)

Organization


Address


Tel


Email



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

県立広島大学 三原キャンパス


Other administrative information

Date of disclosure of the study information

2019 Year 04 Month 01 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

2017 Year 09 Month 25 Day

Date of IRB

2017 Year 09 Month 29 Day

Anticipated trial start date

2017 Year 11 Month 20 Day

Last follow-up date

2018 Year 08 Month 31 Day

Date of closure to data entry

2018 Year 10 Month 31 Day

Date trial data considered complete

2018 Year 10 Month 31 Day

Date analysis concluded

2018 Year 10 Month 31 Day


Other

Other related information



Management information

Registered date

2017 Year 11 Month 16 Day

Last modified on

2019 Year 11 Month 21 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034260


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name