UMIN-CTR Clinical Trial

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

Healthy adults

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO

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

Primary outcomes

JRQLQ

Key secondary outcomes

Doctor views of the nose
Examination for nasal mucus
Discomfort diary of the nose

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Double blind -all involved are blinded

Control

Placebo

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

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

Institute

TTC Co.,Ltd.

Institute

Department

Personal name

Organization

Euglena Co.,Ltd.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2017

Year

08

Month

19

Day

URL releasing protocol

Publication of results

Unpublished

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

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 related information

Registered date

2017

Year

08

Month

18

Day

Last modified on

2019

Year

11

Month

27

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032871