UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019658 |
|---|---|
| Receipt number | R000022713 |
| Scientific Title | Suppression effects on body weight and fat of calcium alginate in healthy adults |
| Date of disclosure of the study information | 2015/11/06 |
| Last modified on | 2017/11/07 09:27:39 |
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Basic information
Public title
Suppression effects on body weight and fat of calcium alginate in healthy adults
Acronym
Diet effect of calcium alginate
Scientific Title
Suppression effects on body weight and fat of calcium alginate in healthy adults
Scientific Title:Acronym
Diet effect of calcium alginate
Region
| Japan |
Condition
Condition
metabolic syndrome
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We will investigate the effect on body weight and fat suppression of calcium alginate using healthy adults.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
The effect on body weight (Measuring point:every week)
Key secondary outcomes
The effect on body fat (Measuring point:
every week)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Placebo
Stratification
YES
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Food |
Interventions/Control_1
Test substance-treated group
Total 4g per day ( in three doses ) for five weeks
Interventions/Control_2
Placebo group
Total 4g per day ( in three doses ) for five weeks
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male
Key inclusion criteria
Body Mass Index is 23 or more but less than 30
Key exclusion criteria
Those who felt this study was inconvenient to everyday life.
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takuo Ogihara |
Organization
Takasaki University of Health and Welfare
Division name
Graduate School, Department of Pharmacology
Zip code
Address
60 Nakaorui-machi, Takasaki-shi, Gunma, Japan
TEL
027-352-1180
togihara@takasaki-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yoko Idota |
Organization
Takasaki University of Health and Welfare
Division name
Faculty of Pharmacy
Zip code
Address
60 Nakaorui-machi, Takasaki-shi, Gunma, Japan
TEL
027-352-1180
Homepage URL
y-idota@takasaki-u.ac.jp
Sponsor or person
Institute
Takasaki University of Health and Welfare
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
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 | 11 | Month | 06 | 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 | 09 | Month | 25 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 11 | Month | 06 | 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 | 11 | Month | 06 | Day |
Last modified on
| 2017 | Year | 11 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022713
