UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000052390 |
|---|---|
| Receipt number | R000059800 |
| Scientific Title | Effect of Daily Ingestion of "from Banana" on bowel movements in healthy volunteers -A Randomized, Double-blind, Cross-over, Placebo-controlled Study- |
| Date of disclosure of the study information | 2023/10/05 |
| Last modified on | 2023/10/03 18:03:35 |
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Basic information
Public title
Effect of Daily Ingestion of "from Banana" on bowel movements
Acronym
Effect of Ingestion of "from Banana" on bowel movements
Scientific Title
Effect of Daily Ingestion of "from Banana" on bowel movements in healthy volunteers -A Randomized, Double-blind, Cross-over, Placebo-controlled Study-
Scientific Title:Acronym
Effect of Daily Ingestion of "from Banana" on bowel movements in healthy volunteers
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effects of daily ingestion of "From Banana" on bowel movements
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
stool shape, stool color, intensity of stool odor, feeling after defecation, defecation volume, defecation frequency, farts frequency, number of days of defecation before and 2weeks after intake
Key secondary outcomes
Diary on health condition
Base
Study type
Interventional
Study design
Basic design
Cross-over
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
3
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
2-weeks intake of "From Banana" 10g/day
Interventions/Control_2
2-weeks intake of "From Banana" 5g/day and Placebo 5g/day
Interventions/Control_3
2-weeks intake of Placebo 10g/day
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
| 59 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) Japanese males and females aged 20 to 59 years old at the time of informed consent
2) Those who defecate 3 to 5 times per week
3) Those whose life cycle is relatively stable, with no extreme fluctuations in meal times or sleeping hours throughout the week
4) Those who do not skip breakfast and eat three meals a day
Key exclusion criteria
1) Those who daily intake supllements that may affect the test results such as lactic acid bacteria or oligosaccharides
2) Those with severe anemia
3) Those who eat sweets or nutritional jelly instead of meals
4) Those who actively intake fermented foods such as yogurt, kimchi or natto
5) Those who eat more than 5 bananas a week
6) Those who intend to eat a vegetable-centered diet
7) Those who intake medications that may affect the test results such as antibiotics or medications with intestinal regulating effects
8) Those who may be allergic to the test product ingredients
9) Those who are participating in other clinical trials
10) Patients who suffer from a specific disease and are undergoing hospital visits, medication, or treatments
11) Pregnant, possibly pregnant or lactating
12) Persons who are alcoholics
13) Persons with a history of serious hepatic disorder, renal disorder, or cardiac disease
14) Persons with a history or current illness of hepatitis
Target sample size
30
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
White from green Inc.
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
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
| 2023 | Year | 10 | Month | 05 | 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
32
Results
Defecation volume significantly increased after 2-weeks of intake in the 10g FromBanana group.
Results date posted
| 2023 | Year | 10 | Month | 03 | Day |
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
| 2022 | Year | 07 | Month | 13 | Day |
Date of IRB
| 2022 | Year | 08 | Month | 09 | Day |
Anticipated trial start date
| 2022 | Year | 09 | Month | 14 | Day |
Last follow-up date
| 2023 | Year | 02 | Month | 10 | Day |
Date of closure to data entry
| 2023 | Year | 02 | Month | 20 | Day |
Date trial data considered complete
| 2023 | Year | 02 | Month | 28 | Day |
Date analysis concluded
| 2023 | Year | 04 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2023 | Year | 10 | Month | 03 | Day |
Last modified on
| 2023 | Year | 10 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000059800
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