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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000034522
Receipt No. 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

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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
Email 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
Email mizuki@shinshu-u.ac.jp

Sponsor
Institute Department of Preventive Medicine and Public Health, Shinshu University School of Medicine.
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039355

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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