UMIN-CTR Clinical Trial

Basic information
Public title	A study to examine the effects of food intake on relief from eye and nasal discomfort.
Acronym	A study to examine the effects of food intake on relief from eye and nasal discomfort.
Scientific Title	A study to examine the effects of food intake on relief from eye and nasal discomfort.
Scientific Title:Acronym	A study to examine the effects of food intake on relief from eye and nasal discomfort.
Region	Japan

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

Objectives
Narrative objectives1	This study to examine the effects of improving eye and nasal discomfort by ingesting food derived from Shiikuwasa (Citrus depressa Hayata).
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The Japanese Rhinoconjunctivitis Quality of Life Questionnaire version 2002 (JRQLQ No1)
Key secondary outcomes	Assessment of the nasal cavity

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Double blind -all involved are blinded
Control	Placebo
Stratification	YES
Dynamic allocation	NO
Institution consideration
Blocking	YES
Concealment	No need to know

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Food
Interventions/Control_1	The foods that are contained nobiletin and tangeretin
Interventions/Control_2	Placebo
Interventions/Control_3
Interventions/Control_4
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	49 years-old >=
Gender	Male and Female
Key inclusion criteria	1. Male and female aged 20 to 49 2. Persons who have perennial allergies or seasonal allergies as subjective symptoms 3. Persons who can obtain consent for voluntary study participation in writing 4. Persons who are not ill
Key exclusion criteria	1. Persons who regularly consume yogurt or lactic acid bacteria food (more than 4 times a week) 2. Persons who regularly consume citrus fruits and processed foods (at least 4 times a week) 3. Participants in foods and health foods that are described as containing nobiletin and tangeretin 4. Persons who must continue to use drugs that may affect nose and eye symptoms (antiallergic drugs, antihistamines, steroidal vasoconstrictors, antihypertensive drugs, etc.) 6. Persons who may develop allergies to the test foods. 7. Persons who are judged to be inappropriate as subjects from the results of the lifestyle questionnaire 8. Participants in other clinical studies at the start of this study 9. Persons who are pregnant or breastfeeding during the study period 10. A person who is judged unsuitable for study participation by the investigator
Target sample size	34

Research contact person
Name of lead principal investigator	1st name YUTAKA Middle name Last name OGIDOH
Organization	Okinawa TLO Co., Ltd.
Division name	Not Division
Zip code	903-0213
Address	University of the Ryukyus - Industry-academia-government collaboration building 3F
TEL	098-895-1701
Email	ogidoh@okinawa-tlo.com

Public contact
Name of contact person	1st name YUTAKA Middle name Last name OGIDOH
Organization	Okinawa TLO Co., Ltd.
Division name	Not Division
Zip code	903-0213
Address	University of the Ryukyus - Industry-academia-government collaboration building 3F
TEL	098-895-1701
Homepage URL
Email	ogidoh@okinawa-tlo.com

Sponsor
Institute	Okinawa TLO Co., Ltd.
Institute
Department

Funding Source
Organization	Okinawa TLO Co., Ltd.
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Brain Care Clinic Ethics Review Committee
Address	Samon-Cho 13, Isobe Build. 2F, Shinjyuku-ku, Tokyo
Tel	06-6882-1130
Email	ethics_board@drc-web.co.jp

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	いきいきクリニック（大阪府）

Other administrative information
Date of disclosure of the study information	2019 Year 12 Month 26 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	34
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	2019 Year 10 Month 30 Day
Date of IRB	2019 Year 11 Month 22 Day
Anticipated trial start date	2019 Year 12 Month 20 Day
Last follow-up date	2020 Year 03 Month 10 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2019 Year 12 Month 12 Day
Last modified on	2020 Year 08 Month 05 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044309