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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000028724
Receipt No. R000032871
Scientific Title Confirmation of the unpleasant feeling reduction effect of the nose by study food intake:A randomized, double blinded, placebo controlled, and parallel group comparison study
Date of disclosure of the study information 2017/08/19
Last modified on 2019/11/27

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Basic information
Public title Confirmation of the unpleasant feeling reduction effect of the nose by study food intake:A randomized, double blinded, placebo controlled, and parallel group comparison study
Acronym Confirmation of the unpleasant feeling reduction effect of the nose by study food intake
Scientific Title Confirmation of the unpleasant feeling reduction effect of the nose by study food intake:A randomized, double blinded, placebo controlled, and parallel group comparison study
Scientific Title:Acronym Confirmation of the unpleasant feeling reduction effect of the nose by study food intake
Region
Japan

Condition
Condition Healthy adults
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Confirmation of the unpleasant feeling reduction effect of the nose by study food intake
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes JRQLQ
Key secondary outcomes Doctor views of the nose
Examination for nasal mucus
Discomfort diary of the nose

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 4
Purpose of intervention Prevention
Type of intervention
Food
Interventions/Control_1 Ingestion of food including beta-glucan (low dose) for 12 consecutive weeks
Interventions/Control_2 Ingestion of food including beta-glucan (high dose) for 12 consecutive weeks
Interventions/Control_3 Ingestion of food including uncrystallized beta-glucan for 12 consecutive weeks
Interventions/Control_4 Ingestion of placebo for 12 consecutive weeks
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
64 years-old >=
Gender Male and Female
Key inclusion criteria (1)Adult men and women from 20 to 64 years of age
(2)Subjects with discomfort of nose (sneeze,runny nose,nasal)
(3)Subjects positive for specific IgE (RAST) against house dust or mite.
(4)Subjects who the discomfort of the nose is "light" and "slightly heavy" in JRQLQ
Key exclusion criteria (1)Subjects who routinely use health food including functional substance richly
(2)Subjects who routinely take foods or medicines affecting the test result
(3)Subjects judged as unsuitable for the study who cannot stop an intake of the food which may have an influence on the discomfort of the nose
(4)Subjects who are under treatment or have a history of serious disease(e.g., diabetes, liver disease, kidney disease, or heart disease)
(5)Subjects having a disease under treatment or a history of serious diseases for which medication was required
(6)Subjects having possibilities for emerging allergy related to the study
(7)Subjects judged as unsuitable for this study based on the results of clinical examination or cardiopulmonary abnormality
(8)Subjects who are judged as unsuitable for the study based on the results of clinical and physical examination on preliminary examination
(9)Subjects who have participated in other clinical study within the last one month prior to the current study or are planned to participate in other clinical study after informed consent for the current study
(10)Subjects who intend to become pregnant or lactating
(11)Subjects who are judged as unsuitable for the study based on the results of lifestyle questionnaire
(12)Subjects judged as unsuitable for the study by the investigator for other reasons
Target sample size 48

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yuta Asayama
Organization Euglena Co.,Ltd.
Division name Health Care Business Division
Zip code
Address 5-33-1, Shiba Minato-ku, Tokyo
TEL 03-3455-4907
Email asayama@euglena.jp

Public contact
Name of contact person
1st name
Middle name
Last name Chiharu Goto
Organization TTC Co.,Ltd.
Division name Clinical Research Planning Department
Zip code
Address Seibu Shinkin Bank Ebisu Bldg.,1-20-2, Ebisunishi, Shibuya-ku, Tokyo
TEL 03-5459-5329
Homepage URL
Email c.goto@ttc-tokyo.co.jp

Sponsor
Institute TTC Co.,Ltd.
Institute
Department

Funding Source
Organization Euglena 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
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

Other administrative information
Date of disclosure of the study information
2017 Year 08 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
2017 Year 08 Month 04 Day
Date of IRB
2017 Year 08 Month 04 Day
Anticipated trial start date
2017 Year 08 Month 20 Day
Last follow-up date
2017 Year 12 Month 24 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2017 Year 08 Month 18 Day
Last modified on
2019 Year 11 Month 27 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032871

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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