UMIN-CTR Clinical Trial

Basic information
Public title	Clinical Study to Investigate the Effect of the Functional Food on Improving Minor Health Complaints: An Open-Label, Uncontrolled Pilot Study
Acronym	NARO Style plus BENTO study
Scientific Title	Clinical Study to Investigate the Effect of the Functional Food on Improving Minor Health Complaints: An Open-Label, Uncontrolled Pilot Study
Scientific Title:Acronym	NARO Style plus BENTO study
Region	Japan

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

Objectives
Narrative objectives1	To investigate improving minor health complaints associated with 8 weeks daily ingestion of the functional food, in an open-label, uncontrolled pilot study.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The Brief Job Stress Questionnaire (Section B) at 8weeks after beginning the intake of test food.
Key secondary outcomes	Blood pressure, pulse rate, body weight, BFP, basal metabolic rate, muscle mass, internal water content, BMI, survey on subjects' sleeping, bowel movement, mental and physical condition, sense of accomplishment, change of daily behavior

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Prevention
Type of intervention	Food
Interventions/Control_1	The subjects take the test food during 8weeks (5meals/ w and 1meal/ d).
Interventions/Control_2
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.Subjects with informed consent for the study participation. 2.Subjects with minor health complaints.
Key exclusion criteria	1.Subjects with implantable electronic medical devices. 2.Subjects who receive nourishment instruction. 3.Subjects who cannot take the test food during 8weeks because of allergy risk and so on. 4.Subjects whose lifestyle is expected to change significantly. 5.Subjects who currently participate in other clinical trials, or participated within the last 4 wks prior to the current study. 6.Any other medical and/or health reasons unfavorable to participation in the current study, as judged by the principal investigator.
Target sample size	50

Research contact person
Name of lead principal investigator	1st name Naoyuki Middle name Last name HONMA
Organization	Hokkaido Information University
Division name	Department of Medical Management and Informatics
Zip code	069-8585
Address	59-2, Nishi-nopporo, Ebetsu, Hokkaido, 069-8585, Japan
TEL	011-385-4411
Email	hisc-acad.res@s.do-johodai.ac.jp

Public contact
Name of contact person	1st name Naoyuki Middle name Last name HONMA
Organization	Hokkaido Information University
Division name	Health Information Science Center
Zip code	011-385-4430
Address	59-2, Nishi-nopporo, Ebetsu, Hokkaido, 069-8585, Japan
TEL	011-385-4430
Homepage URL
Email	hisc-acad.res@s.do-johodai.ac.jp

Sponsor
Institute	Hokkaido Information University
Institute
Department

Funding Source
Organization	National Agriculture and Food Research Organization, bio-oriented technology Research Advancement Institution
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization	Japan

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

IRB Contact (For public release)
Organization	The ethics committee of Hokkaido Information University
Address	59-2, Nishi-nopporo, Ebetsu, Hokkaido, 069-8585, Japan
Tel	011-385-4411
Email	soumu@do-johodai.ac.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	北海道情報大学　保健センター（北海道）

Other administrative information
Date of disclosure of the study information	2021 Year 09 Month 17 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	2021 Year 08 Month 27 Day
Date of IRB	2021 Year 08 Month 27 Day
Anticipated trial start date	2021 Year 09 Month 24 Day
Last follow-up date	2022 Year 01 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2021 Year 09 Month 13 Day
Last modified on	2022 Year 06 Month 01 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051889