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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000026681
Receipt No. R000030639
Scientific Title Evaluation of Polysaccharide Containing Food on Fecal Mineral Excretion
Date of disclosure of the study information 2017/03/25
Last modified on 2019/10/15

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Basic information
Public title Evaluation of Polysaccharide Containing Food on Fecal Mineral Excretion
Acronym Evaluation of Polysaccharide Containing Food on Fecal Mineral Excretion
Scientific Title Evaluation of Polysaccharide Containing Food on Fecal Mineral Excretion
Scientific Title:Acronym Evaluation of Polysaccharide Containing Food on Fecal Mineral Excretion
Region
Japan

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

Objectives
Narrative objectives1 To evaluate the efficacy of Polysaccharide containing food on fecal mineral excretion by cross-over clinical trial with healthy adult male subjects.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Average amount of mineral excreted daily into feces
Key secondary outcomes Safety evaluation including subjective symptoms, examination by a physician in charge, hematology test, biochemical exam of blood serum chemistry, and urinary test.

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Randomized
Randomization unit Individual
Blinding Double blind -all involved are blinded
Control Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment No need to know

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Food
Interventions/Control_1 Daily intake of control food for 7 days.
Washout period (7days or more).
Daily intake of test food for 7days.
Interventions/Control_2 Daily intake of test food for 7 days.
Washout period (7 days or more).
Daily intake of control food for 7 days.
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
40 years-old >
Gender Male
Key inclusion criteria (1) Japanese males from 20 to 39 years of age when consented.
(2) Subjects with no abnormal test results in screening test.
(3) Subjects with 7 to 9 times of defecation per week.
(4) Subjects with regular mealtimes throughout the day.
(5) Subjects available for every designated hospital admission.
(6) Subjects who agree to participate in this study and can put signature and date to informed consent form by themselves prior to the study.
Key exclusion criteria (1) Subjects with hepatic, renal, cardiac or organ disorders, diabetes, or other serious diseases.
(2) Subjects with a surgical history of digestive system (except appendicectomy).
(3) Subjects currently under treatment with chronic diseases.
(4) Subjects who regularly take intestinal drugs or health foods which may influence intestinal regulation (including Food for Specified Health Uses and Foods with Function Claims).
(5) Subjects who work on midnight and irregular shifts.
(6) Subjects who cannot take preset meals to be delivered during the intake periods of test or placebo food, or who cannot comply with the requirement not to eat food other than the presets meals.
(7) Subjects who cannot stop smoking and drinking alcohol during the intake periods of test or placebo food.
(8) Subjects judged as unsuitable for the study by the principal investigator for other reasons.
Target sample size 10

Research contact person
Name of lead principal investigator
1st name Kazuhiko
Middle name
Last name Takano
Organization Medical Corporation Hokubukai Utsukushigaoka Hospital
Division name Clinical Pharmacology Center
Zip code 004-0839
Address 61-1, Sinei, Kiyota-ku, Sapporo, Hokkaido, Japan
TEL 011-882-0111
Email takano@ughp-cpc.jp

Public contact
Name of contact person
1st name Ryota
Middle name
Last name Wakimoto
Organization Medical Corporation Hokubukai Utsukushigaoka Hospital
Division name Clinical Pharmacology Center
Zip code 004-0839
Address 61-1, Sinei, Kiyota-ku, Sapporo, Hokkaido, Japan
TEL 011-882-0111
Homepage URL
Email wakimoto@ughp-cpc.jp

Sponsor
Institute Medical Corporation Hokubukai Utsukushigaoka Hospital
Institute
Department

Funding Source
Organization KOBAYASHI Pharmaceutical Co., Limited
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization Medical Corporation Hokubukai Utsukushigaoka Hospital institutional review board
Address 61-1, Sinei, Kiyota-ku, Sapporo, Hokkaido, Japan
Tel 0118820111
Email wakimoto@ughp-cpc.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 医療法人北武会 美しが丘病院(北海道)

Other administrative information
Date of disclosure of the study information
2017 Year 03 Month 25 Day

Related information
URL releasing protocol Evaluation of Polysaccharide Containing Food on Fecal Mineral Excretion
Publication of results Unpublished

Result
URL related to results and publications It was measured mineral in the stool.
Number of participants that the trial has enrolled 10
Results
It was measured mineral in the stool.
Results date posted
2019 Year 10 Month 15 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
(1) Japanese males from 20 to 39 years of age when consented. 
(2) Subjects with no abnormal test results in screening test. 
(3) Subjects with 7 to 9 times of defecation per week. 
(4) Subjects with regular mealtimes throughout the day. 
(5) Subjects available for every designated hospital admission. 
(6) Subjects who agree to participate in this study and can put signature and date to informed consent form by themselves prior to the study. 
Participant flow
Daily intake of control food for 7 days. 
Washout period (7days or more). 
Daily intake of test food for 7days.


Daily intake of test food for 7 days. 
Washout period (7 days or more). 
Daily intake of control food for 7 days.
Adverse events
Gastrointestinal symptoms
Outcome measures
Mineral in the stool
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2017 Year 03 Month 09 Day
Date of IRB
2017 Year 03 Month 09 Day
Anticipated trial start date
2017 Year 04 Month 04 Day
Last follow-up date
2017 Year 11 Month 02 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2017 Year 03 Month 24 Day
Last modified on
2019 Year 10 Month 15 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030639

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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