UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000055089 |
|---|---|
| Receipt number | R000062924 |
| Scientific Title | A study on the use of plant-derived components A and B to improve intestinal environment. |
| Date of disclosure of the study information | 2024/07/26 |
| Last modified on | 2024/07/26 16:18:14 |
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Basic information
Public title
A study on the use of plant-derived components A and B to improve intestinal environment.
Acronym
A study on the use of plant-derived components A and B to improve intestinal environment.
Scientific Title
A study on the use of plant-derived components A and B to improve intestinal environment.
Scientific Title:Acronym
A study on the use of plant-derived components A and B to improve intestinal environment.
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effects of the combined intake of plant-derived component A and B on the intestinal environment.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Intestinal microflora analysis, organic acid analysis in stool, polyamine analysis in stool
Key secondary outcomes
Defecation status, Questionnaire on physical condition, MOS Short-Form 36-Item Health Survey
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Consume cookies containing plant-derived ingredient A and beverages containing plant-derived ingredient B for 4 weeks. After washout, placebo cookies and placebo beverages will be consumed for 4 weeks.
Interventions/Control_2
Consume placebo cookies and placebo beverages for 4 weeks. After washout, cookies containing plant-derived ingredient A and beverages containing plant-derived ingredient B will be consumed for 4 weeks.
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) Healthy Japanese men and women between the ages of 20 and less than 60 years old at the time of consent acquisition.
2) Subjects who defecate 3-5 times per week.
3) Non-smokers
4) Subjects who regularly consume three meals a day.
5) Subjects who have been fully informed of the purpose and content of the research, have the capacity to consent, and have voluntarily volunteered to participate in the research based on a good understanding of the purpose and content of the research, and have agreed to participate in the research in writing.
Key exclusion criteria
1) Subjects who regularly use laxatives, bowel preparation, etc.
2) Subjects who are visiting the hospital for treatment of disease or receiving medication.
3) Subjects who have taken antibiotics within 1 month of the screening test.
4) Subjects who take protein powder or protein-fortified foods.
5) Subjects who take health foods fortified with dietary fiber (including food for specified health use, functional foods, health supplements, and nutritional supplements)
6) Subjects who consume foods containing live bacteria such as lactobacilli, bifidobacteria, and bacillus natto, oligosaccharides, and other foods good for improving constipation and the intestinal environment, and foods containing large amounts of sugar alcohol at least 3 times a week.
7) Subjects who cannot avoid consuming protein powder, protein-fortified foods, and foods fortified with dietary fiber during the study period.
8) Subjects who are unable to maintain their pre-study eating and lifestyle habits with regard to diet, exercise, and sleep throughout the study period.
9) Subjects who have difficulty with the protein bar itself, bitter taste, or taste of mixed vegetable juice (tomato/carrot mixed juice).
10) Subjects who reported having food allergies.
11) Subjects who drink excessive amounts of alcohol on a daily basis (more than 20 g/day of pure alcohol equivalent three times or more per week).
12) Subjects who have smoked in the past year.
13) Subjects who are pregnant, intend to become pregnant during the study period, or are breastfeeding.
14) Subjects whose menstrual cycle changes significantly each time, subjects undergoing treatment for menopausal disorders.
15) Subjects who have participated, are participating, or intend to participate after obtaining consent, in research using other foods or drugs during the month prior to obtaining consent.
*Items numbered 16 and thereafter are listed in the other related information section.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Shingo/ Satoshi |
| Middle name | |
| Last name | Takahashi/ Ota |
Organization
KAGOME CO., LTD./FUJI OIL HOLDINGS INC.
Division name
Diet & Well-being Research Institute/Research Institute for Creating the Future
Zip code
329-2762/300-2497
Address
17, Nishitomiyama, Nasushiobara-shi, Tochigi/4-3 Kinunodai, Tsukubamirai-shi, Ibaraki
TEL
0287-36-2935(0297-52-6325)
Shingo_Takahashi@kagome.co.jp
Public contact
Name of contact person
| 1st name | Yoshika |
| Middle name | |
| Last name | Komori |
Organization
KSO Corporation
Division name
Clinical Trial Management Department
Zip code
105-0023
Address
Shibaura Omodaka Building 7F, 1-9-7, Shibaura Minato-ku Tokyo
TEL
03-3452-7733
Homepage URL
eigyou27@kso.co.jp
Sponsor or person
Institute
KAGOME CO., LTD./ FUJI OIL HOLDINGS INC.
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
KSO Corporation
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethical Committee of Kobuna Orthopedics Clinic
Address
5-656-17 Joto-machi, Maebashi-shi, Gunma
Tel
027-212-5608
sagawa@mc-connect.co.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
医療法人 前橋北病院（群馬県）（Maebashi North Hospital）
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 07 | Month | 26 | 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
Preinitiation
Date of protocol fixation
| 2024 | Year | 07 | Month | 25 | Day |
Date of IRB
| 2024 | Year | 07 | Month | 25 | Day |
Anticipated trial start date
| 2024 | Year | 09 | Month | 04 | Day |
Last follow-up date
| 2024 | Year | 12 | Month | 07 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The following describes the contents of numbers 16 through 23 of the key exclusion criteria.
16) Subjects suffering from a disease requiring urgent treatment or subjects with serious complications.
17) Subjects with gastrointestinal diseases affecting digestion, absorption or defecation, or a history of gastrointestinal surgery (excluding appendicectomy).
18) Subjects with a history or current history of drug or alcohol dependence.
19) Subjects who have been diagnosed with irritable bowel syndrome (IBS) or inflammatory bowel disease (IBD).
20) Subjects who cannot abstain from alcohol for 3 days prior to the screening test or each test.
21) Shift workers or late-night workers.
22) Subjects who have donated more than 200 mL of blood or blood components within 1 month or 400 mL of blood or blood components within 3 months before the date of consent.
23) Subjects who are judged by the principal investigator to be inappropriate as research subjects based on the answers to the research subject questionnaire, screening tests, and other factors.
Management information
Registered date
| 2024 | Year | 07 | Month | 26 | Day |
Last modified on
| 2024 | Year | 07 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000062924
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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