UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031545 |
|---|---|
| Receipt number | R000036020 |
| Scientific Title | Visceral fat-reducing effect of food containing the milk-derived ingredient |
| Date of disclosure of the study information | 2018/03/02 |
| Last modified on | 2019/03/04 09:15:46 |
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Basic information
Public title
Visceral fat-reducing effect of food containing the milk-derived ingredient
Acronym
Visceral fat-reducing effect of food containing the milk-derived ingredient
Scientific Title
Visceral fat-reducing effect of food containing the milk-derived ingredient
Scientific Title:Acronym
Visceral fat-reducing effect of food containing the milk-derived ingredient
Region
| Japan |
Condition
Condition
No (healthy adults)
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the visceral fat-reducing effect of food containing the milk-derived ingredient
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Visceral fat area
Key secondary outcomes
Subcutaneous fat area, Total fat area, Waist circumference, Hip circumference, Body weight, BMI
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 the milk-derived ingredient, 12 weeks
Interventions/Control_2
Food non-containing the milk-derived ingredient, 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) Japanese males and females aged 20 to 64 years old at the time of acquiring consent.
(2) Subjects whose BMI are 23 to 29.9 at the screening test.
(3) Subjects with visceral fat areas of more than 70 cm2 at the screening test.
(4) Subjects who provided written informed consent.
Key exclusion criteria
(1) Subjects with the metabolic syndrome.
(2) Subjects who have taken medication or surgery due to serious illness or injury within one month before the start of the study.
(3) Subjects who have serious diseases in the heart, liver, kidney or digestive organs in the present or past.
(4) Subjects who take a medicine for hyperglycemia, hyperlipidemia or hypertension.
(5) Subjects who regularly use drugs or functional foods affecting the study.
(6) Subjects who are pregnant or lactating.
(7) Heavy drinkers or heavy smokers.
(8) Subjects with milk allergy.
(9) Subjects who are judged as unsuitable for the study by the investigator for the other reason.
Target sample size
140
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Ikuo Fukuhara |
Organization
Fukuhara Clinic
Division name
Director
Zip code
Address
3-1-15, Shima-matsuhigashi machi, Eniwa-shi, Hokkaido, Japan
TEL
0123-36-8029
i-feniwa@gray.plala.or.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shimpei Tomita |
Organization
New drug research center, Inc.
Division name
Clinical Research Dept.
Zip code
Address
452-1, Toiso, Eniwa-shi, Hokkaido, Japan
TEL
0123-34-0412
Homepage URL
s-tomita@ndrcenter.co.jp
Sponsor or person
Institute
New drug research center, Inc.
Institute
Department
Personal name
Funding Source
Organization
LION Corporation
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
福原医院（北海道）
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 03 | Month | 02 | 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
| 2018 | Year | 02 | Month | 08 | Day |
Date of IRB
Anticipated trial start date
| 2018 | Year | 03 | 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
| 2018 | Year | 03 | Month | 02 | Day |
Last modified on
| 2019 | Year | 03 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036020
