UMIN-CTR Clinical Trial

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
Last 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
1st 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