UMIN-CTR Clinical Trial

Basic information
Public title	Effect to BMI by the helth program supporting intake of dietary fiber
Acronym	Effect to BMI by the helth program supporting intake of dietary fiber
Scientific Title	Effect to BMI by the helth program supporting intake of dietary fiber
Scientific Title:Acronym	Effect to BMI by the helth program supporting intake of dietary fiber
Region	Japan

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

Objectives
Narrative objectives1	To evaluate the effect to BMI by the helth program supporting intake of dietary fiber
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	BMI before and 4-8-12weeks after intake, 4 weeks after the end of intake
Key secondary outcomes	blood test, blood pressure,physical activity, food intake, defecation frequency, defecation quantity,body weight, body-fat percentage before and 4-8-12weeks after intake, 4 weeks after the end of intake

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	Treatment
Type of intervention	Food
Interventions/Control_1	Intake dietary fiber-rich food once a day for 12 weeks
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) Japanese males and females aged 20 to 60 years old 2) Subjects who can perform informed consent 3) Subjects who can connect to the specific application and come to the clinic to perform tests under the schedule 4) Subjects who can fill down their daily food intake, body weight and blood pressure to the specific application 4) Subjects who can measure their body weight and blood pressure everyday using the supplied scale 6) Subjects who can cook and intake the test food at least 5 times a week 4) Subjects with HbA1c(NGSP) 5.2 to 6.4 % 8) Subjects with BMI 25 to 30
Key exclusion criteria	1) Subjects who are taking medical treatments 2) Subjects who have severe medical history of mental/sleep/liver/kidny/heart/lung nad /or blood disease 3) Subjects who have severe medical history of digestive disease 4) Subjects who have performed blood donation over 200mL in the past 1 month or over 400 ml in the past 3 months 5) Subjects who have experienced bad mood or poor physical condition due to blood sampling in the past 6) Subjects who can be allergic to test food 7) Heavy drinkers (Average amount of pure alcohol per day 60 g or more). 8) Subjects who will chage their life style (e.g. long-term trip) 9) Subjects who are pregnant, breast-feeding or have possibility (hope) of pregnancy. 10) Subjects who participated in other clinical studies in the past 3 months. 11) Subjects who/whose families are engaged in development, manufacture or sell of health food or cosmetics
Target sample size	50

Research contact person
Name of lead principal investigator	1st name Takashi Middle name Last name Koikeda
Organization	Shiba Palace Clinic
Division name	Chair
Zip code	105-0013
Address	DaiwaA Hamamatsucho Bldg. 6F, 1-9-10, Hamamatsucho, Minato-ku, Tokyo, 105-0013, JAPAN
TEL	03-5408-1590
Email	jimukyoku@mail.souken-r.com

Public contact
Name of contact person	1st name Ko Middle name Last name Masuda
Organization	SOUKEN Co., Ltd
Division name	Management Division
Zip code	105-0013
Address	DaiwaA Hamamatsucho Bldg. 3F, 1-9-10, Hamamatsucho, Minato-ku, Tokyo, 105-0013, JAPAN
TEL	03-5408-1555
Homepage URL
Email	k_masuda@mail.souken-r.com

Sponsor
Institute	Shiba Palace Clinic
Institute
Department

Funding Source
Organization	Welby 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	Shiba Palace Clinic Ethics Review Committee
Address	DaiwaA Hamamatsucho Bldg. 6F, 1-9-10, Hamamatsucho, Minato-ku, Tokyo, 105-0013, JAPAN
Tel	03-5408-1599
Email	shiba_palace@s-palace-clinic.com

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 06 Month 15 Day

Related information
URL releasing protocol	Unpublished
Publication of results	Unpublished

Result
URL related to results and publications	Unpublished
Number of participants that the trial has enrolled	59
Results	Unpublished
Results date posted	2022 Year 04 Month 12 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics	Unpublished
Participant flow	Unpublished
Adverse events	Unpublished
Outcome measures	Unpublished
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2020 Year 03 Month 26 Day
Date of IRB	2020 Year 03 Month 26 Day
Anticipated trial start date	2020 Year 06 Month 15 Day
Last follow-up date	2020 Year 12 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	2020 Year 04 Month 08 Day
Last modified on	2022 Year 04 Month 12 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000045694