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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000018527
Receipt No. R000021417
Scientific Title Safety evaluation studies of long-term consumption of food containing resistant glucan (water-soluble dietary fiber) in healthy subjects or subjects with high triglyceride levels or pre-diabetic subjects
Date of disclosure of the study information 2015/08/21
Last modified on 2016/06/14

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Basic information
Public title Safety evaluation studies of long-term consumption of food containing resistant glucan (water-soluble dietary fiber) in healthy subjects or subjects with high triglyceride levels or pre-diabetic subjects
Acronym Safety evaluation studies of long-term consumption of food containing resistant glucan (water-soluble dietary fiber) in healthy subjects or subjects with high triglyceride levels or pre-diabetic subjects
Scientific Title Safety evaluation studies of long-term consumption of food containing resistant glucan (water-soluble dietary fiber) in healthy subjects or subjects with high triglyceride levels or pre-diabetic subjects
Scientific Title:Acronym Safety evaluation studies of long-term consumption of food containing resistant glucan (water-soluble dietary fiber) in healthy subjects or subjects with high triglyceride levels or pre-diabetic subjects
Region
Japan

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

Objectives
Narrative objectives1 To evaluate the safety of long-term consumption of food containing resistant glucan (water-soluble dietary fiber), quantity of recommended daily intake.
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Adverse event
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Food
Interventions/Control_1 Ingestion of the test product for 12 weeks
Interventions/Control_2
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
64 years-old >=
Gender Male and Female
Key inclusion criteria (1) Healthy adult males and females from 20 to 64 years of age
(2) Subjects falling under any of the following
A. triglyceride levels are ranged from 120 mg/dL to 199 mg/dL (10 or more subjects)
B. blood fasting glucose levels are ranged from 110 mg/dL to 125 mg/dL (10 or more subjects)
C. triglyceride levels are less than 120 mg/dL and blood fasting glucose levels are less than 110 mg/dL (10 or more subjects)
Key exclusion criteria (1) Subjects having a disease requiring treatment or a history of serious diseases, diabetes, hepatopathy, renal or heart disease
(2) Subjects having possibilities for emerging allergy related to the study
(3) Subjects having a disease requiring treatment or a history of serious diseases for which medication was required
(4) Subjects who are judged as unsuitable for the study based on the results of clinical and physical examination on preliminary examination
(5) Subjects who have participated in other clinical study within the last one month prior to the current study or are planned to participate in other clinical study after informed consent for the current study
(6) Subjects who intend to become pregnant or lactating
(7) Subjects who are judged as unsuitable for the study based on the results of lifestyle questionnaire
(8) Subjects judged as unsuitable for the study by the investigator for other reasons
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Toshihiro Yamamoto
Organization NIHON SHOKUHIN KAKO CO., LTD.
Division name RESEARCH INSTITUTE
Zip code
Address 30 TAJIMA FUJI, SHIZUOKA
TEL 0545-53-5995
Email toshihiro.yamamoto@nisshoku.co.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yuki Kitahara
Organization TTC Co.,Ltd.
Division name Clinical Research Planning Department
Zip code
Address Seibu Shinkin Bank Ebisu Bldg.,1-20-2, Ebisunishi, Shibuya-ku, Tokyo
TEL 03-5459-5329
Homepage URL
Email y.kitahara@ttc-tokyo.co.jp

Sponsor
Institute TTC Co.,Ltd.
Institute
Department

Funding Source
Organization NIHON SHOKUHIN KAKO CO., LTD.
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
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

Other administrative information
Date of disclosure of the study information
2015 Year 08 Month 21 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
2015 Year 07 Month 23 Day
Date of IRB
Anticipated trial start date
2015 Year 08 Month 22 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2015 Year 08 Month 03 Day
Last modified on
2016 Year 06 Month 14 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021417

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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