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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000030001
Receipt No. R000034260
Scientific Title Verification of the sialagogic effect in food
Date of disclosure of the study information 2019/04/01
Last modified on 2017/11/16

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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
Institute Prefectural University of Hiroshima.
Institute
Department

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 Preinitiation
Date of protocol fixation
2017 Year 09 Month 25 Day
Date of IRB
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
2017 Year 11 Month 16 Day


Link to view the page
URL(English) https://upload.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


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