UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040105 |
|---|---|
| Receipt number | R000045694 |
| Scientific Title | Effect to BMI by the helth program supporting intake of dietary fiber |
| Date of disclosure of the study information | 2020/06/15 |
| Last modified on | 2022/04/12 08:13:57 |
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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
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
k_masuda@mail.souken-r.com
Sponsor or person
Institute
Shiba Palace Clinic
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045694
