UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026681 |
|---|---|
| Receipt number | 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 17:49:53 |
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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
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
wakimoto@ughp-cpc.jp
Sponsor or person
Institute
Medical Corporation Hokubukai Utsukushigaoka Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030639
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| Registered date | File name |
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