UMIN-CTR Clinical Trial

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