![]() |
UMIN-CTR Clinical Trial |
|
![]() |
![]() |
![]() |
![]() |
Name: | UMIN ID: |
Recruitment status | Preinitiation |
Unique ID issued by UMIN | UMIN000047914 |
Receipt No. | R000054608 |
Scientific Title | Exploratory study of the effect of continuous intake of food ingredients on bowel condition |
Date of disclosure of the study information | 2022/06/22 |
Last modified on | 2022/06/01 |
Basic information | ||
Public title | Exploratory study of the effect of continuous intake of food ingredients on bowel condition | |
Acronym | Exploratory study of the effect of continuous intake of food ingredients on bowel condition | |
Scientific Title | Exploratory study of the effect of continuous intake of food ingredients on bowel condition | |
Scientific Title:Acronym | Exploratory study of the effect of continuous intake of food ingredients on bowel condition | |
Region |
|
Condition | |||
Condition | Not applicable | ||
Classification by specialty |
|
||
Classification by malignancy | Others | ||
Genomic information | NO |
Objectives | |
Narrative objectives1 | Exploratory assesment of the effect of continuous intake of food ingredients on bowel condition |
Basic objectives2 | Efficacy |
Basic objectives -Others | |
Trial characteristics_1 | |
Trial characteristics_2 | |
Developmental phase |
Assessment | |
Primary outcomes | Bowel index |
Key secondary outcomes |
Base | |
Study type | Interventional |
Study design | |
Basic design | Parallel |
Randomization | Randomized |
Randomization unit | Individual |
Blinding | Double blind -all involved are blinded |
Control | Placebo |
Stratification | |
Dynamic allocation | |
Institution consideration | |
Blocking | |
Concealment |
Intervention | ||
No. of arms | 4 | |
Purpose of intervention | Prevention | |
Type of intervention |
|
|
Interventions/Control_1 | Subjects will take the placebo food once a day for 4 weeks. | |
Interventions/Control_2 | Subjects will take the functional food 1 once a day for 4 weeks. | |
Interventions/Control_3 | Subjects will take the functional food 2 once a day for 4 weeks. | |
Interventions/Control_4 | Subjects will take the comparative food once a day for 4 weeks. This group is open but assessor(s) are blinded, because it is deferent in form from placebo food and functional food. | |
Interventions/Control_5 | ||
Interventions/Control_6 | ||
Interventions/Control_7 | ||
Interventions/Control_8 | ||
Interventions/Control_9 | ||
Interventions/Control_10 |
Eligibility | ||||
Age-lower limit |
|
|||
Age-upper limit |
|
|||
Gender | Male and Female | |||
Key inclusion criteria | (1) Male and Female whose age are 20 <= years old <65.
(2) Subjects who can use a iPhone without any problems. (3) Subjects who can receive explanations and inspections in a remote environment. (4) Subjects who can submit the informed consents. |
|||
Key exclusion criteria | (1) Subjects who are undergoing some medical treatment at the onset of this study.
(2) Subjects who are pregnant, lactation,(or planning to become pregnant) (3) Subjects whose systolic blood pressure is less than 90mmHg. (4) Subjects who are still participating in other clinical studies, or who finished clinical study within the last 4 weeks. (5) Subjects who are; a) With disease on heart, liver, kidney or other organs complications. b) With a previous history of disease on circulatory organs. c) Have diabetes mellitus. d) With test food allergy. (6) Subjects who are constantly taking certain drug medicine, or who are expecting taking it within the period of current study, or who have indispensable supplements, functional foods affecting the test results. (7) Subjects who have severe allergic reaction to medicines and/or test food related products. (8) Subjects who drink over 60 g of alcohol per day on average. (9) Subjects who have irregular eating patterns. (10) Subjects who work irregular hours such as late night, or those who plan to do so in the future. (11) Subjects who plan to change their lifestyle during the scheduled study period. (12) Subjects whose BMI is less than 18.5 or over 30.0 kg/m2. (13) Subjects who have had or are currently suffering from serious intestinal diseases (ulcerative colitis, Crohn's disease, colorectal cancer, appendicitis, etc) (14) Subjects with a cardiac pacemaker. (15) Subjects who are judged as unsuitable for the study by the principal investigator for other reasons. |
|||
Target sample size | 240 |
Research contact person | |||||||
Name of lead principal investigator |
|
||||||
Organization | Suntory Global Innovation Center Ltd. | ||||||
Division name | Research Institute | ||||||
Zip code | 6190284 | ||||||
Address | 8-1-1 Seikadai, Seika-cho, Soraku-gun, Kyoto, Japan | ||||||
TEL | 050-3182-0464 | ||||||
Mitsuhiro_Zeida@suntory.co.jp |
Public contact | |||||||
Name of contact person |
|
||||||
Organization | Suntory Global Innovation Center Ltd. | ||||||
Division name | Research Institute | ||||||
Zip code | 6190284 | ||||||
Address | 8-1-1 Seikadai, Seika-cho, Soraku-gun, Kyoto, Japan | ||||||
TEL | 050-3182-0556 | ||||||
Homepage URL | |||||||
Norimasa_Kanegawa@suntory.co.jp |
Sponsor | |
Institute | Suntory Global Innovation Center Ltd. |
Institute | |
Department |
Funding Source | |
Organization | Suntory Global Innovation Center 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 | Healthcare Systems Co., Ltd. |
Address | 4-6-15, Shimmbashi, Minato-ku, Tokyo |
Tel | 03-6809-2722 |
soumu@hc-sys.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 |
Other administrative information | |||||||
Date of disclosure of the study information |
|
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 | Preinitiation | ||||||
Date of protocol fixation |
|
||||||
Date of IRB | |||||||
Anticipated trial start date |
|
||||||
Last follow-up date |
|
||||||
Date of closure to data entry | |||||||
Date trial data considered complete | |||||||
Date analysis concluded |
Other | |
Other related information |
Management information | |||||||
Registered date |
|
||||||
Last modified on |
|
Link to view the page | |
URL(English) | https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054608 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
Registered date | File name |
Research case data | |
Registered date | File name |