UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026291 |
|---|---|
| Receipt number | R000030198 |
| Scientific Title | Examination study on abdominal visceral fat reducing action by functional food intake -Randomized placebo-controlled double-blind parallel group comparison study- |
| Date of disclosure of the study information | 2017/04/07 |
| Last modified on | 2017/09/11 11:58:14 |
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Basic information
Public title
Examination study on abdominal visceral fat reducing action by functional food intake
-Randomized placebo-controlled double-blind parallel group comparison study-
Acronym
Examination study on abdominal visceral fat reducing action by functional food intake
Scientific Title
Examination study on abdominal visceral fat reducing action by functional food intake
-Randomized placebo-controlled double-blind parallel group comparison study-
Scientific Title:Acronym
Examination study on abdominal visceral fat reducing action by functional food intake
Region
| Japan |
Condition
Condition
Not applicable
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effect of intake of functional food for 12 weeks on abdominal fat area reduction and safety in males and females with abdominal obesity aged 20-64
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
<Efficacy>
Abdominal visceral fat area, at 8 and 12 weeks after intake
<Safety>
Side effect incidence
Key secondary outcomes
<Efficacy>
Abdominal subcutaneous fat area and abdominal whole fat area, at 8 and 12 weeks after intake
Waist circumference diameter, hip circumference diameter, body weight, BMI, total cholesterol, HDL-cholesterol, LDL-cholesterol, and fasting blood glucose at 4,8 and 12 weeks after intake
HbA1c and adiponectin at 12 weeks after intake
<Safety>
Adverse event incidence, clinical examination items excluding efficacy evaluation items, and physiological examination items excluding efficacy evaluation items
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
YES
Dynamic allocation
NO
Institution consideration
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Intake of test food for 12 weeks
Interventions/Control_2
Intake of placebo food for 12 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
| 20 | years-old | <= |
Age-upper limit
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. Males and females equal to or more than 20 years and less than 65 years of age
2. Subjects equal to or more than 24 and less than 30 kg/m^2 of BMI
3. Subjects who recognize the object and contents of the study and submit the written informed consent
Key exclusion criteria
1. Subjects who have a history of severe illness and current medical history in the heart, liver, kidney, digestive organs
2. Subjects who fall under the
diagnostic criteria of metabolic syndrome
3. Subjects who received medication treatment or surgery due to serious illness or injury within 2 months from the start of this study
4. Subjects who use drugs of
glycometabolism, lipidmetabolism, or reducing high blood pressure
5. Subjects who regularly use drugs, health foods, supplements which are suggested causal relationship from the study except who agree to quit taking them
6. Pregnant and lactating female, or who wish to get pregnant during the study period
7. Heavy dinkers
8. Subjects who feel bad mood by blood collection in past
9. Subjects who donated 200 mL or more of blood within 1 month from the start of the test or subjects who plan to do so during the test period
10. Subjects who have been
constipated for more than 5 days
11. Shift worker
12. Subjects who have allergy related to the test foods
13. Subjects already participating in other clinical trials, subjects
planning to participate during this examination period
14. Subjects who can not agree with the purpose of this test conducted in advance
15. Subjects who are ineligible due to physician's judgment
Target sample size
70
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Ikuo Fukuhara |
Organization
Fukuhara Clinic
Division name
Hospital director
Zip code
Address
3-1-15 Shimamatsuhigashi-machi Eniwa, Hokkaido, Japan
TEL
0123-36-8029
i-feniwa@gray.plala.or.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tomita Shimpei |
Organization
New drug research center, Inc.
Division name
Clinical Research Dept.
Zip code
Address
452-1Toiso,Eniwa-shi,Hokkaido, Japan
TEL
0123-34-0412
Homepage URL
s-tomita@ndrcenter.co.jp
Sponsor or person
Institute
Maruzen Pharmaceuticals Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
Maruzen Pharmaceuticals 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
| 2017 | Year | 04 | Month | 07 | 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 | 02 | Month | 23 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 04 | Month | 07 | 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
| 2017 | Year | 02 | Month | 24 | Day |
Last modified on
| 2017 | Year | 09 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030198
