UMIN-CTR Clinical Trial

Basic information
Public title	Effects of a Test Food Containing an Extract of Unripe Mandarins for Reducing Allergic Reaction of Eyes or Nose.
Acronym	Effects of a Test Food Containing an Extract of Unripe Mandarins for Reducing Allergic Reaction of Eyes or Nose.
Scientific Title	Effects of a Test Food Containing an Extract of Unripe Mandarins for Reducing Allergic Reaction of Eyes or Nose.
Scientific Title:Acronym	Effects of a Test Food Containing an Extract of Unripe Mandarins for Reducing Allergic Reaction of Eyes or Nose.
Region	Japan

Condition
Condition	N/A(healthy adults)
Classification by specialty	Not applicable Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	This study aims to examine effects of a test food containing an extract of unripe mandarins for reducing allergic reaction of eyes or nose.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	[1]Indexes for allergic rhinitis (Japan Rhinitis Quality of Life Questionnaire No. 1(1), grading the severity of allergic rhinitis(2), grading of local findings(2), eyes and nose condition based on subject's diary(3), effect measurement(4)) (1):Week 0, 2, 4, 6, 8, 10, 12. (2):Week 0, 6, 12. (3)From the first day of ingestion of a test material to the last day of the test. (4)Week 12.
Key secondary outcomes	*Secondary outcomes [1]Specific measurementf of nasal discharge and blood (nasal discharge eosinophils(1), eosinophil(1), nonspecific IgE(1), specific IgE(2)). (1):Week 0, 6, 12. (2):Week 0, 12. *Safety evaluation [1]Hematologic test(1). [2]Blood biochemical test(1). [3]Urine analysis(1). [4]Blood pressure, pulsation(1). [5]Weight, body fat percentage, BMI(1). [6]Doctor's questions(1). (1):Week 0, 6, 12. *Other indexes [1]Questionnaire for allergic rhinitis(1). [2]Subject's diary(2). (1):Week 0. (2)From the first day of ingestion of a test material to the last day of the 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	2
Purpose of intervention	Treatment
Type of intervention	Food
Interventions/Control_1	Oral ingestion of the test food (2 capsules once a day for 12 weeks).
Interventions/Control_2	Oral ingestion of the placebo food (2 capsules once a day for 12 weeks).
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	65 years-old >
Gender	Male and Female
Key inclusion criteria	[1]Japanese males and females aged 20-64 years. [2]Individuals who are healthy and are not suffered from a chronic malady. [3]Individuals with allergic reaction of eyes and nose in early spring. [4]Individuals whose written informed consent has been obtained. [5]Individuals who can visit an inspection facility and be inspected in designated days. [6]Individuals judged appropriate for the study by the principal.
Key exclusion criteria	[1]Individuals using medical products. [2][2]Individuals who use an antiallergic drug or steroid drug or will use during the test period. [3]Individuals who have history of intranasal laser therapy to reduce allergic symptoms. [4]Individuals who are a patient of or have a history of bronchial disease. [5]Individuals who are patient or have a history of mental disease, psychiatric disease, high blood pressure, diabetes, and hyperlipidemia. [6]Individuals who used a drug to treat a disease in the past 1 month (except temporal usage for pollenosis). [7]Individuals who are sensitive to other foods and medical products. [8]Individuals who contract or have a history of serious hepatopathy, kidney damage, heart disease and blood disease. [9]Individuals who are a patient or have a history of or endocrine disease. [10]Individuals whose BMI is over 30 kg/m2. [11]Individuals who donated blood over 200mL in the past 1 month or over 400mL in the past 3 months. [12]Individuals who had a habit to ingest health-promoting foods, foods for specified health uses, health foods, or supplements containing similar composition with a test food in the past 1 month or will ingest those foods during the test period. [13]Individuals who had a habit to ingest health-promoting foods, foods for specified health uses, health foods, or supplements in the past 1 months or will ingest those foods during the test period to reduce allergic symptoms. [14]Individuals who excessively take alcohol (expressed in an amount of alcohol: over 60 mg/day). [15]Individuals with possible changes of life style, such as conducting a long-term travel, during the test period. [16]Individuals who are or are possibly, or are lactating. [17]Individuals who have a habit to use drug claiming to improve skin condition in the past 3 months. [18]Individuals who are or whose family is engaged in healthy or functional foods. [19]Individuals judged inappropriate for the study by the principal.
Target sample size	68

Research contact person
Name of lead principal investigator	1st name Takahiro Middle name Last name Ono
Organization	Ueno-Asagao Clinic
Division name	Head
Zip code	110-0015
Address	6F Kairaku Building 2-7-5 Higashiueno Taito-ku Tokyo 110-0015, JAPAN
TEL	+81-3-6240-1162
Email	info@ueno-asagao.clinc

Public contact
Name of contact person	1st name Ryoma Middle name Last name Shimizu
Organization	TES Holdings Co., Ltd.
Division name	Administrative Department of Clinical Trials
Zip code	110-0015
Address	6F Kairaku Building 2-7-5 Higashiueno Taito-ku Tokyo 110-0015, JAPAN
TEL	+81-3-6801-8480
Homepage URL
Email	r.shimizu@tes-h.co.jp

Sponsor
Institute	TES Holdings Co., Ltd.
Institute
Department

Funding Source
Organization	Nikken Foods 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	Ueno-Asagao Clinic Ethical Review Committee
Address	6F Kairaku Building 2-7-5 Higashiueno Taito-ku Tokyo 110-0015, JAPAN
Tel	+81-3-6240-1162
Email	jimukyoku@tes-h.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

Other administrative information
Date of disclosure of the study information	2020 Year 01 Month 23 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	2019 Year 12 Month 10 Day
Date of IRB	2019 Year 12 Month 11 Day
Anticipated trial start date	2020 Year 01 Month 28 Day
Last follow-up date	2020 Year 04 Month 26 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other

Other related information

Revision of the Protocol (2nd version; 16th April 2020) Due to the declaration of the State of Emergency by the Japanese Government and the requirement of staying at home by both Japanese and Tokyo Metropolitan Governments in relation to the COVID-19, the safety and security of the subjects and staff have been our first priority. As a result, we decided to cancel the test at the Week 12 and to extend it to the Week 16. Ueno-Asagao Clinic Ethical Review Committee (Approval date: 17th April 2020, Approval number: 2019-39-J1) Revision of the Protocol (3rd version; 15th May 2020) Due to the extend period of the declaration of the State of Emergency by the Japanese Government and the requirement of staying at home by both Japanese and Tokyo Metropolitan Governments in relation to the COVID-19, we decided to cancel the test at the Week 16 and to extend it to the Week 18. Ueno-Asagao Clinic Ethical Review Committee (Approval date: 15th March 2020, Approval number: 2019-39-J2)

Management information
Registered date	2020 Year 01 Month 23 Day
Last modified on	2021 Year 10 Month 28 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044685