Unique ID issued by UMIN | UMIN000055089 |
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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 |
A study on the use of plant-derived components A and B to improve intestinal environment.
A study on the use of plant-derived components A and B to improve intestinal environment.
A study on the use of plant-derived components A and B to improve intestinal environment.
A study on the use of plant-derived components A and B to improve intestinal environment.
Japan |
Healthy adults
Not applicable | Adult |
Others
NO
To evaluate the effects of the combined intake of plant-derived component A and B on the intestinal environment.
Efficacy
Intestinal microflora analysis, organic acid analysis in stool, polyamine analysis in stool
Defecation status, Questionnaire on physical condition, MOS Short-Form 36-Item Health Survey
Interventional
Cross-over
Randomized
Individual
Open -no one is blinded
Placebo
2
Prevention
Food |
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.
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.
20 | years-old | <= |
60 | years-old | > |
Male and Female
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.
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.
20
1st name | Shingo/ Satoshi |
Middle name | |
Last name | Takahashi/ Ota |
KAGOME CO., LTD./FUJI OIL HOLDINGS INC.
Diet & Well-being Research Institute/Research Institute for Creating the Future
329-2762/300-2497
17, Nishitomiyama, Nasushiobara-shi, Tochigi/4-3 Kinunodai, Tsukubamirai-shi, Ibaraki
0287-36-2935(0297-52-6325)
Shingo_Takahashi@kagome.co.jp
1st name | Yoshika |
Middle name | |
Last name | Komori |
KSO Corporation
Clinical Trial Management Department
105-0023
Shibaura Omodaka Building 7F, 1-9-7, Shibaura Minato-ku Tokyo
03-3452-7733
eigyou27@kso.co.jp
KAGOME CO., LTD./ FUJI OIL HOLDINGS INC.
None
Self funding
KSO Corporation
Ethical Committee of Kobuna Orthopedics Clinic
5-656-17 Joto-machi, Maebashi-shi, Gunma
027-212-5608
sagawa@mc-connect.co.jp
NO
医療法人 前橋北病院(群馬県)(Maebashi North Hospital)
2024 | Year | 07 | Month | 26 | Day |
Unpublished
Preinitiation
2024 | Year | 07 | Month | 25 | Day |
2024 | Year | 07 | Month | 25 | Day |
2024 | Year | 09 | Month | 04 | Day |
2024 | Year | 12 | Month | 07 | Day |
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.
2024 | Year | 07 | Month | 26 | Day |
2024 | Year | 07 | Month | 26 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000062924
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