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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000027410
Receipt No. R000031343
Scientific Title A clinical study for evaluating efficacy and safety of long-term consumption
Date of disclosure of the study information 2017/06/01
Last modified on 2018/04/20

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Basic information
Public title A clinical study for evaluating efficacy and safety of long-term consumption
Acronym A clinical study for evaluating efficacy and safety of long-term consumption
Scientific Title A clinical study for evaluating efficacy and safety of long-term consumption
Scientific Title:Acronym A clinical study for evaluating efficacy and safety of long-term consumption
Region
Japan

Condition
Condition Healthy adults
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 We verify the efficacy and safety of long-term consumption of "FGPPY30" for 12 weeks(by taking its normal dose).
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes -Defecation status
-Appearance of adverse events
(period: from Visit0 to visit3)
Key secondary outcomes -Inspection concerning degree of obesity
(weight, BMI and CT)
-State of face skin
-Examination on feeling of fatigue
(Pittsburgh Sleep Quality Index Japanese Version, OSA sleep inventory MA version and Profile of Mood States 2nd Edition-Adult Short)
-Congnitive function test
(Trail Making Test)
-Height,weight and BMI
-Body temperature, blood pressure and pulse
-12-lead electrocardiogram
-General hematology test
-Blood biochemistry test
-Urinalysis
-Defecation status(times ofdefecation, amount of defecation, fecal properties)

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 Numbered container method

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Food
Interventions/Control_1 Intake normal dose of test food "FGPPY30" for 84 days, every day
Interventions/Control_2 Intake normal dose of plasebo for 84 days, every day
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
50 years-old >=
Gender Male and Female
Key inclusion criteria Target subject must satisfy the following selection criteria.
1) Healthy Japanese aged from 20 to 59 years-old at the time of giving informed consent
2) Constipation tenders who have 2-5 stool defecations from -7 days to -1 day
3) A person who is not using chronic or seasonal drugs or medical equipment and is not undergoing rehabilitation therapy
4) A person who has freely given informed consent and has fully understood the purpose of the study
5) A person whose BMI is from 18.5 to 30.0
6) When measuring blood pressure twice, a person whose average blood pressure is within a range of followings;Systolic blood pressure: less than or equal to 139mmHg
Diastolic blood pressure: less than or equal to 89mmHg
7) A person whose pulse rate is from 40 to 100 per minute
8) A person whose body temperature is from 35.5 to 37.0 degree Celsius
9) A person who can prevent from excessive exercise during the study
10) A person who can basically have 3 meals in a day during the study
11) A person who can conduct contraception by appropriate ways during the study
12) A person who understands and follows rules and requirements during the study
13) A person who is considered totally fit for participating the study by a comprehensive judgement of lead principal investigator and others
Key exclusion criteria The following exclusion criteria apply to subjects.
1) A person with the disease in gastrointestinal tract, liver, kidney, heart and circulatory system which have an influence on the absorption, distribution, metabolism and excretion of test food
2) A person with a major surgery history in the gastrointestinal tract sites such as gastrectomy, stomach and intestines suture, the intestinal resection (however, polypectomy, the a ppendectomy are excluded)
3) A person with a history of cerebrovasculardisorder
4) A person with tattoo which has an influence on the study because of its size or range
5) A person with hypersensitivity or idiosyncrasy, such as food allergy
6) A person who is suspected to have alcohol or drug dependence
7) A person who has participated in other clinical trials within 84 days from giving an informed consent
8) A person who donated 400 ml of blood within 84 days, 200 ml within 28 days, or a blood component (plasma or platelets) within 14 days from giving an informed consent
9) A nursing or pregnant woman
10) A person who is engaged in night duty
11) A person who has taken foods mainly composed of "FGPPY30" within 28 days from the day that he/she gave an informed consent
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Akihito Yoshida
Organization MEDOC Medical Dock & Clinic
Division name internal medicine
Zip code
Address 4-3, Yasudadori, Showa-ku, Nagoya-shi, Aichi, 466-0857, Japan
TEL 052-752-1135
Email chiken@medoc.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hiromichi Hayashi
Organization Medeical Fusion Co.,Ltd.
Division name Clinical development division
Zip code
Address Nagoya Life Science Incubator, 2-22-8, Chikusa, Chikusa-ku, Nagoya, Aichi, 464-0858, Japan
TEL 052-745-3300
Homepage URL http://www.m-fusion.co.jp/
Email info@m-fusion.co.jp

Sponsor
Institute Sun- O International Co., Ltd.
Institute
Department

Funding Source
Organization Sun- O International Co., Ltd.
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization Japan

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

IRB Contact (For public release)
Organization
Address
Tel
Email

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 メドック健康クリニック(愛知県)

Other administrative information
Date of disclosure of the study information
2017 Year 06 Month 01 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
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
2017 Year 05 Month 15 Day
Date of IRB
Anticipated trial start date
2017 Year 06 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
2018 Year 04 Month 20 Day
Date analysis concluded

Other
Other related information

Management information
Registered date
2017 Year 05 Month 19 Day
Last modified on
2018 Year 04 Month 20 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031343

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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