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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000029430
Receipt No. 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

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Basic information
Public title A Randomized, Double-Blind, Placebo-Controlled, Parallel Group Comparison Study on Effects of Daily Ingestion of Plant Powder on Bowel Movements.
Acronym Effects of Daily Ingestion of Plant Powder on Bowel Movements.
Scientific Title A Randomized, Double-Blind, Placebo-Controlled, Parallel Group Comparison Study on Effects of Daily Ingestion of Plant Powder on Bowel Movements.
Scientific Title:Acronym Effects of Daily Ingestion of Plant Powder on Bowel Movements.
Region
Japan

Condition
Condition Healthy adults
Classification by specialty
Not applicable Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To prove clinical benefits associated with daily ingestion of plant powder for 2 weeks on bowel movements.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Defecation frequency after 1 and 2 weeks of ingestion.
Key secondary outcomes Stool amount, stool shape, stool color, stool odor, feeling after defecation and VAS questionnaire.

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Double blind -all involved are blinded
Control Placebo
Stratification YES
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking YES
Concealment No need to know

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Food
Interventions/Control_1 Ingestion of 4.2 g of plant granules daily for 2 weeks.
Interventions/Control_2 Ingestion of 4.2 g of placebo granules daily for 2 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
65 years-old >
Gender Male and Female
Key inclusion criteria 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.
Key exclusion criteria 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.
Target sample size 72

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Prof. Jun NISHIHIRA, M.D., Ph.D.
Organization Hokkaido Information University
Division name Department of Medical Management and Informatics
Zip code
Address 59-2, Nishi-nopporo, Ebetsu, Hokkaido, 069-8585, Japan
TEL 011-385-4411
Email nishihira@do-johodai.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Dir. Prof. Jun NISHIHIRA, M.D., Ph.D.
Organization Hokkaido Information University
Division name Health Information Science Center
Zip code
Address 59-2, Nishi-nopporo, Ebetsu, Hokkaido, 069-8585, Japan
TEL 011-385-4430
Homepage URL
Email nishihira@do-johodai.ac.jp

Sponsor
Institute Hokkaido Information University
Institute
Department

Funding Source
Organization The Ethics Committee approves that the source of funding shall not be disclosed.
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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 北海道情報大学 保健センター(北海道)

Other administrative information
Date of disclosure of the study information
2017 Year 10 Month 06 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 Completed
Date of protocol fixation
2017 Year 09 Month 08 Day
Date of IRB
Anticipated trial start date
2017 Year 10 Month 13 Day
Last follow-up date
2017 Year 11 Month 29 Day
Date of closure to data entry
2017 Year 12 Month 26 Day
Date trial data considered complete
2018 Year 01 Month 09 Day
Date analysis concluded
2018 Year 11 Month 30 Day

Other
Other related information

Management information
Registered date
2017 Year 10 Month 05 Day
Last modified on
2019 Year 02 Month 28 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033607

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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