UMIN-CTR Clinical Trial

Basic information
Public title	Clinical Evaluation of the Efficacy of Mixed Vegetables and Fruits Juice on Perennial Allergic Rhinitis of Healthy Subjects
Acronym	Effects of Mixed Vegetables and Fruits Juice on Perennial Allergic Rhinitis
Scientific Title	Clinical Evaluation of the Efficacy of Mixed Vegetables and Fruits Juice on Perennial Allergic Rhinitis of Healthy Subjects
Scientific Title:Acronym	Effects of Mixed Vegetables and Fruits Juice on Perennial Allergic Rhinitis
Region	Japan

Condition
Condition	Healthy adults
Classification by specialty	Not applicable Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The aim of this study is to evaluate the efficacy of intervention with mixed vegetables and fruits juice on perennial allergic rhinitis of healthy subjects.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Nasal symptom score(Record score using a 5-point scale) before and 2, 4, 6, 8 weeks after the intervention with mixed vegetables and fruits juice or placebo.
Key secondary outcomes	Nasal symptom score (Japan Rhinoconjunctivitis Quality of Life Questionnaire (JRQLQ)), Ocular symptom score, QOL score (JRQLQ), non-specific IgE, Allergen-specific IgE, eosinophil count in nasal discharge, Serum carotenoid concentrations

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
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Prevention
Type of intervention	Food
Interventions/Control_1	Mixed vegetables and fruits juice (195 mL/day for 8 weeks)
Interventions/Control_2	Placebo (195 mL/day for 8 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	60 years-old >
Gender	Male and Female
Key inclusion criteria	1) Healthy Japanese subjects 2) Subjects who notice themselves as they are mild/moderate perennial allergic rhinitis. 3) Subjects who have positive results on serum allergen-specific IgE against house dust or mites. 4) Subjects who are judged suitable for this study by principal investigator.
Key exclusion criteria	1) Subjects who have positive results on serum allergen-specific IgE against Poaceae or Ambrosia artemisiifolia and are judged that symptoms of allergic rhinitis depend on their antigen. 2) Subjects who have non-allergic rhinitis 3) Subjects who have acute rhinitis, sinusitis, nasal polyp, hypertrophic rhinitis, and deviated septum. 4) Subjects who take medicines such as anti-histamine and anti-allergy. 5) Subjects who have bronchial asthma as a complication. 6) Subjects who currently receive or have previously received allergen immunotherapy. 7) Subjects who have current medical history of serious disease in heart, liver, kidney and digestive system. 8) Subjects who have previous medical history of serious disease and be judged unsuitable for this study by principal investigator. 9) Subjects who will be treated or take medicine for perennial allergic rhinitis during this study period. 10) Subjects who have vegetables-based diet 11) Subjects who intake the medicines, the foods for specified health uses and/or the health foods that are concerned their influence to test results. 12) Pregnant or expected pregnant, planning pregnant during this study period and lactating women 13) Subjects who cannot take test food and record diary as instructions. 14) Subjects who habitually consume higher amount of alcohol (=> 60 g alcohol/day) 15) Subjects with risk of allergy regarding to this study 16) Subjects who are participating in the other clinical tests. Subjects who participated in the other clinical tests within 2-months prior to this study and/or who plan to participate in the other clinical tests. 17) Subjects who donated over defined blood and/or blood components amounts before this study. 18) Subjects who are judged unsuitable for this study by principal investigator and doctors.
Target sample size	96

Research contact person
Name of lead principal investigator	1st name Takuro Middle name Last name Inoue
Organization	Kagome CO.,LTD.
Division name	Innovation Division
Zip code	329-2762
Address	17 Nishitomiyama, Nasushiobarashi, Tochigi, 329-2762, Japan
TEL	0287-36-2935
Email	Takuro_Inoue@kagome.co.jp

Public contact
Name of contact person	1st name Suguru Middle name Last name Fujiwara
Organization	CPCC Co., Ltd.
Division name	Clinical Research Department
Zip code	101-0047
Address	4F Sanwauchikanda Building, 3-3-5 Uchikanda Chiyoda-ku, Tokyo 101-0047, JAPAN
TEL	03-5297-3112
Homepage URL
Email	cpcc-contact@cpcc.co.jp

Sponsor
Institute	Kagome CO., LTD.
Institute
Department

Funding Source
Organization	Kagome CO., LTD.
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor	CPCC Co., Ltd.
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Chiyoda Paramedical Care Clinic IRB
Address	2F Sanwauchikanda Building, 3-3-5 Uchikanda Chiyoda-ku, Tokyo 101-0047, JAPAN
Tel	03-5297-5548
Email	IRB@cpcc.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	チヨダパラメディカルケアクリニック(東京都)/Chiyoda Paramedical Care Clinic)

Other administrative information
Date of disclosure of the study information	2019 Year 09 Month 06 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 08 Month 27 Day
Date of IRB	2019 Year 08 Month 27 Day
Anticipated trial start date	2019 Year 09 Month 07 Day
Last follow-up date	2020 Year 01 Month 31 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 09 Month 04 Day
Last modified on	2020 Year 03 Month 05 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000043223