Unique ID issued by UMIN | UMIN000029430 |
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Receipt number | R000033607 |
Scientific Title | A Randomized, Double-Blind, Placebo-Controlled, Parallel Group Comparison Study on Effects of Daily Ingestion of Plant Powder on Bowel Movements. |
Date of disclosure of the study information | 2017/10/06 |
Last modified on | 2019/02/28 14:19:24 |
A Randomized, Double-Blind, Placebo-Controlled, Parallel Group Comparison Study on Effects of Daily Ingestion of Plant Powder on Bowel Movements.
Effects of Daily Ingestion of Plant Powder on Bowel Movements.
A Randomized, Double-Blind, Placebo-Controlled, Parallel Group Comparison Study on Effects of Daily Ingestion of Plant Powder on Bowel Movements.
Effects of Daily Ingestion of Plant Powder on Bowel Movements.
Japan |
Healthy adults
Not applicable | Adult |
Others
NO
To prove clinical benefits associated with daily ingestion of plant powder for 2 weeks on bowel movements.
Efficacy
Pragmatic
Not applicable
Defecation frequency after 1 and 2 weeks of ingestion.
Stool amount, stool shape, stool color, stool odor, feeling after defecation and VAS questionnaire.
Interventional
Parallel
Randomized
Individual
Double blind -all involved are blinded
Placebo
YES
NO
Institution is not considered as adjustment factor.
YES
No need to know
2
Treatment
Food |
Ingestion of 4.2 g of plant granules daily for 2 weeks.
Ingestion of 4.2 g of placebo granules daily for 2 weeks.
20 | years-old | <= |
65 | years-old | > |
Male and Female
1. Subjects with defecation frequency between minimum 3 to maximum 5 per week.
2. Subjects who are aware of having a tendency to constipation.
3. Subjects who agree to participate in this study with a written informed consent.
1. Subjects with a clinical history of gastrointestinal cancer or currently under treatment or anti-tumor medication.
2. Subjects with gastrointestinal disorders such as inflammatory bowel syndrome, irritable bowel syndrome, etc.
3. Subjects who regularly take anticoagulants (e.g., warfarin).
4. Subjects with serious cerebrovascular, cardiac, hepatic, renal, gastrointestinal diseases, and/or affected with infectious diseases requiring reports to the authorities.
5. Subjects with major surgical history relevant to digestive system such as gastrectomy, gastrorrhaphy, enterectomy, etc.
6. Subjects with unusually high and/or low blood pressure and/or abnormal hematological data.
7. Subjects with severe anemia.
8. Pre- or post-menopausal women complaining obvious physical changes.
9. Subjects who are at risk of having allergic reactions to drugs or foods (especially gramineous plants such as rice, wheat and corn).
10. Subjects who regularly take drugs, functional foods and/or supplements which potentially affect bowel movements.
11. Subjects who cannot abstain from taking any of health-oriented foods (including Food for Specified Health Uses), fortified foods with dietary fiber or oligosaccharide, yoghurt, lactic acid bacteria beverage, natto during the preliminary investigation and the study period.
12. Heavy smokers, alcohol addicts or subjects with disordered lifestyle.
13. Subjects who donated either 400ml whole blood within 12 weeks (men) /16 weeks (women) prior to the screening tests or 200ml whole blood within 4 weeks or blood components within 2 weeks prior to the screening tests.
14. Pregnant or lactating women or women expect to be pregnant during this study.
15. Subjects who currently participate in other clinical trials or participated within the last 4 weeks prior to the current study.
16. Any other medical and/ or health reasons unfavorable to participation into the current study judged by the principal investigator.
72
1st name | |
Middle name | |
Last name | Prof. Jun NISHIHIRA, M.D., Ph.D. |
Hokkaido Information University
Department of Medical Management and Informatics
59-2, Nishi-nopporo, Ebetsu, Hokkaido, 069-8585, Japan
011-385-4411
nishihira@do-johodai.ac.jp
1st name | |
Middle name | |
Last name | Dir. Prof. Jun NISHIHIRA, M.D., Ph.D. |
Hokkaido Information University
Health Information Science Center
59-2, Nishi-nopporo, Ebetsu, Hokkaido, 069-8585, Japan
011-385-4430
nishihira@do-johodai.ac.jp
Hokkaido Information University
The Ethics Committee approves that the source of funding shall not be disclosed.
Profit organization
Japan
NO
北海道情報大学 保健センター(北海道)
2017 | Year | 10 | Month | 06 | Day |
Unpublished
Completed
2017 | Year | 09 | Month | 08 | Day |
2017 | Year | 10 | Month | 13 | Day |
2017 | Year | 11 | Month | 29 | Day |
2017 | Year | 12 | Month | 26 | Day |
2018 | Year | 01 | Month | 09 | Day |
2018 | Year | 11 | Month | 30 | Day |
2017 | Year | 10 | Month | 05 | Day |
2019 | Year | 02 | Month | 28 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033607
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