UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034522 |
|---|---|
| Receipt number | R000039355 |
| Scientific Title | The research on the effect on the smell and fecal properties of stool due to intake of Salacia -Randomized double blind study- |
| Date of disclosure of the study information | 2018/10/26 |
| Last modified on | 2019/05/07 14:23:49 |
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Basic information
Public title
The research on the effect on the smell and fecal properties of stool due to intake of Salacia -Randomized double blind study-
Acronym
The research on the effect on the smell and fecal properties of stool due to intake of Salacia
Scientific Title
The research on the effect on the smell and fecal properties of stool due to intake of Salacia -Randomized double blind study-
Scientific Title:Acronym
The research on the effect on the smell and fecal properties of stool due to intake of Salacia
Region
| Japan |
Condition
Condition
None(Healthy adults)
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate changes of smell and fecal properties of stool by ingesting Salacia
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Changes in smell and fecal properties of stool after ingesting Salacia
Key secondary outcomes
Change in mood state after ingesting Salacia and safety assessment of Salacia
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Taking tablets of Salacia
Interventions/Control_2
Taking tablets of placebo tablets (0 mg of Salacia)
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
| 55 | years-old | <= |
Age-upper limit
| 70 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1) Male and female aged 55 to 69
2) Person who gained written participation consent based on his / her free will after having received sufficient explanation
3) Taking a meal three times a day
4) Not constipation
Key exclusion criteria
1) Being treated due to chronic diseases such as hypertension, hyperlipidemia, dyslipidemia, diabetes, rheumatism, cerebrovascular disease, renal disorder, liver disorder (especially hepatitis), other anemia
2) There is a history of heart disease such as heart failure, myocardial infarction, atrial fibrillation, arrhythmia, etc. or during treatment
3) The digestive tract is hypersensitive
4) Frequent intake of supplements, intestinal preparations, fermented foods, and dairy products that affect the intestinal flora
5) There are allergies such as test foods and medicines
6) Smoking people, taking excessive alcohol
7) No carbohydrate intake at least once a day
8) The life rhythm is irregular
9) Participated in other clinical trials within 3 months or currently participating
10) it is difficult to describe the questionnaire
11) In addition, if the doctor in charge of examination admits that it is not appropriate for participation
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Tetsuo |
| Middle name | |
| Last name | Nomiyama |
Organization
Shinshu University School of Medicine
Division name
Department of Preventive Medicine and Public Health
Zip code
3908621
Address
3-1-1 Asahi, Matsumoto, Nagano Prefecture
TEL
0263-37-2622
nomiyama@shinshu-u.ac.jp
Public contact
Name of contact person
| 1st name | Masaru |
| Middle name | |
| Last name | Mizuki |
Organization
Shinshu University School of Medicine
Division name
Department of Preventive Medicine and Public Health
Zip code
3908621
Address
3-1-1 Asahi, Matsumoto, Nagano Prefecture
TEL
0263-37-2622
Homepage URL
mizuki@shinshu-u.ac.jp
Sponsor or person
Institute
Department of Preventive Medicine and Public Health, Shinshu University School of Medicine.
Institute
Department
Personal name
Funding Source
Organization
FUJIFILM Corporation
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
Shinshu University School of Medicine Medical Ethics Committee
Address
3-1-1 Asahi, Matsumoto, Nagano Prefecture
Tel
0263-37-2572
mdrinri@shinshu-u.ac.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
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 10 | Month | 26 | 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
31
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
| 2018 | Year | 10 | Month | 02 | Day |
Date of IRB
| 2018 | Year | 07 | Month | 03 | Day |
Anticipated trial start date
| 2018 | Year | 10 | Month | 17 | Day |
Last follow-up date
| 2018 | Year | 12 | Month | 04 | Day |
Date of closure to data entry
| 2019 | Year | 01 | Month | 24 | Day |
Date trial data considered complete
| 2019 | Year | 01 | Month | 31 | Day |
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 10 | Month | 16 | Day |
Last modified on
| 2019 | Year | 05 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039355
