UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018527 |
|---|---|
| Receipt number | 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 08:48:54 |
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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
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
y.kitahara@ttc-tokyo.co.jp
Sponsor or person
Institute
TTC Co.,Ltd.
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021417
