UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015999 |
|---|---|
| Receipt number | R000018551 |
| Scientific Title | A Clinical Study for Evaluating the Safety of Long-term Consumption of Food Containing Polydextrose A Randomized, Double-blind, Placebo-controlled, Parallel-group Study |
| Date of disclosure of the study information | 2014/12/24 |
| Last modified on | 2021/02/18 13:51:27 |
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Basic information
Public title
A Clinical Study for Evaluating the Safety of Long-term Consumption of Food Containing Polydextrose
A Randomized, Double-blind, Placebo-controlled, Parallel-group Study
Acronym
A Clinical Study for Evaluating the Safety of Long-term Consumption of Food Containing Polydextrose
Scientific Title
A Clinical Study for Evaluating the Safety of Long-term Consumption of Food Containing Polydextrose
A Randomized, Double-blind, Placebo-controlled, Parallel-group Study
Scientific Title:Acronym
A Clinical Study for Evaluating the Safety of Long-term Consumption of Food Containing Polydextrose
Region
| Japan |
Condition
Condition
No(subjects with fasting serum triglyceride levels 30-199 mg/dL)
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 polydextrose for 12 weeks
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Biochemical examination, Hematological examination, urine analysis, vital signs
Key secondary outcomes
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
Treatment
Type of intervention
| Food |
Interventions/Control_1
Food containing polydextrose
Interventions/Control_2
Food not containing polydextrose
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
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
(1)Healthy males and females aged 20 to 64 years old
(2)Subjects whose fasting serum triglyceride levels are from 30 mg/dL to 199 mg/dL
(3)Subjects who can stop drinking from 2 days before each measurement
(4)Subjects who can make self-judgment and are voluntarily giving written informed consent
Key exclusion criteria
(1)Subjects who use medications affecting obesity, hyperlipidemia, lipid metabolism, and so on
(2)Subjects who can't stop using supplements and/or functional foods affecting obesity, hyperlipidemia, lipid metabolism, and so on
(3)Subjects who contract serious diabetes, kidney disease, liver disease, and/or disease needing immediate treatment, and who are taking relevant medicines
(4)Subjects who have a history of digestive disease affecting digestion and absorption, and related surgery
(5)Subjects who are under treatment for or have a history of drug addiction and/or alcoholism
(6)Subjects who have been diagnosed as familial hyperlipidemia
(7)Subjects who are planning to become pregnant after informed consent for the current study or are pregnant or lactating
(8)Subjects who have donated blood components and/or blood a volume of 200 mL and over within one month prior to the current study
(9)Subjects who are planning to participate or already participating in other clinical studies
(10)Subjects who are 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 | YASUO |
| Middle name | |
| Last name | THO |
Organization
Medical Corporation Association KUNWA-KAI AIWA CLINIC
Division name
Medical office
Zip code
343-0827
Address
1-590-1 Kawayanagicho, Koshigaya-shi, Saitama
TEL
048-989-2000
kunwakai@aol.com
Public contact
Name of contact person
| 1st name | Yoshika |
| Middle name | |
| Last name | Komori |
Organization
KSO Corporation
Division name
Sales department
Zip code
105-0023
Address
1-9-7 Shibaura, Minato-ku, Tokyo
TEL
03-3452-7733
Homepage URL
yoshi@kso.co.jp
Sponsor or person
Institute
KSO Corporation
Institute
Department
Personal name
Funding Source
Organization
TOYO SHINYAKU 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
AIWA CLINIC institutional review board
Address
1-590-1 Kawayanagicho,Koshigaya-shi, Saitama-ken 343-0827Japan
Tel
048-989-2000
kunwakai@aiwacl.or.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
| 2014 | Year | 12 | Month | 24 | 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
| 2014 | Year | 11 | Month | 25 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 12 | Month | 25 | 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
| 2014 | Year | 12 | Month | 19 | Day |
Last modified on
| 2021 | Year | 02 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018551
