Unique ID issued by UMIN | UMIN000031266 |
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Receipt number | R000035698 |
Scientific Title | Pre-examination: Effect of dietary Mozuku powder on gut microbiota composition. |
Date of disclosure of the study information | 2018/02/15 |
Last modified on | 2018/06/13 09:51:03 |
Pre-examination: Effect of dietary Mozuku powder on gut microbiota
composition.
Pre-examination: Effect of dietary Mozuku powder on gut microbiota
composition.
Pre-examination: Effect of dietary Mozuku powder on gut microbiota
composition.
Pre-examination: Effect of dietary Mozuku powder on gut microbiota
composition.
Japan |
Because it is a test for healthy subjects, there is no target disease.
Adult |
Others
NO
Dietary fiber is metabolized by intestinal fermentation of more than 100 trillion bacteria present in the intestinal tract without being decomposed by the digestive juice at the upper part of the gastrointestinal tract, and is converted into a useful metabolite for the health of the host. In addition to being used as an energy source in intestinal mucosa, this metabolite is known to inhibit proliferation of intestinal putrefactive bacteria, etc., to prepare intestinal environment, promote peristaltic movement of intestine, and promote defecation.
Okinawa virgin soybean is a food with a high content of dietary fiber, and an effect of improving the number of times of defecation by reporting that 2.4 g of dry powder is taken a day is reported. However, since there is no report on intestinal bacterial flora analysis due to ingestion of this powder, a comparative test between the test food intake group containing the dry powder of Okinawawa mozuku and the control test food intake group was planned and the intestinal flora By analysis, Bifidobacterium occupancy ratio to total number of bacteria is determined, and the intestinal action of Okinawan mozuku derived dietary fiber is examined.
Others
usefulness
The ratio of Bifidobacterium to the number of intestinal inner layer bacteria
Defecation status
Interventional
Parallel
Randomized
Individual
Double blind -all involved are blinded
Placebo
2
Treatment
Food |
Dry mozuku powder blending sprinkle
Dry mozuku powder non-blended sprinkle
20 | years-old | <= |
65 | years-old | > |
Male and Female
1. Healthy people who do not have severe disease
2. A person who wishes voluntarily to participate in clinical trials in men and women aged 20 years or over and under 65 years old and who can obtain written informed consent
3.Those who can withdraw laxatives, constipation drugs, supplements expected to have bowel improvement effect, health tea etc during the examination period.
4. people with constipation tendency (stool frequency ~ 3 times / week, excluding severe constipation)
5. Those who do not take supplements that are predicted to constantly improve constipation medicine and bowel movement within the first month
6. Who can keep daily lifestyle habits constant during the examination period
7. Study participation of people who are treating mild chronic diseases (hypertension, hyperlipemia, etc.) shall be able to participate at the discretion of the investigator
1. People with severe diseases (heart disease, liver disease, kidney disease, cancer, etc.) and mental illness.
2. People with digestive system disease history and surgery history of digestive organs.
3. constipation who may be caused by diseases (colorectal cancer, Crohn's disease, etc.) and drugs (anticholinergics, antidepressants, etc.)
4. Those who can not maintain everyday life habits with large changes in diet and exercise.
5. If you work on shifts, work at midnight.]
6. Persons who constantly take on laxatives, constipation medicine and supplements, health tea etc. expected to improve bowel movement regularly or within 1 month of the month within 1 month.
7. Possible food allergy and drug allergy to the test food.
8. Pregnant women / lactating women and those who wish pregnant during the examination period.
9. Others who have made the examination responsible doctor ineligible for participation in this exam.
10. Those who participate in other clinical trials within the past month.
26
1st name | |
Middle name | |
Last name | Ono, Seiichi |
Wellbe Inc.
Clinical Research Division
Tanahara BLDG 3F, 1-3-2 Nishihara, Urasoe, Okinawa, Japan
098-988-9007
abe@well-b.jp
1st name | |
Middle name | |
Last name | Abe, Hiroyuki |
Wellbe Inc.
Clinical Research Division
Tanahara BLDG 3F, 1-3-2 Nishihara, Urasoe, Okinawa, Japan
098-988-9007
abe@well-b.jp
Wellbe Inc.
Okinawa Prefecture
Local Government
Japan
NO
2018 | Year | 02 | Month | 15 | Day |
Unpublished
No longer recruiting
2018 | Year | 01 | Month | 18 | Day |
2018 | Year | 02 | Month | 03 | Day |
2018 | Year | 03 | Month | 31 | Day |
2018 | Year | 03 | Month | 31 | Day |
2018 | Year | 03 | Month | 31 | Day |
2018 | Year | 03 | Month | 31 | Day |
2018 | Year | 02 | Month | 13 | Day |
2018 | Year | 06 | Month | 13 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000035698
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