UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033428 |
|---|---|
| Receipt number | R000038119 |
| Scientific Title | Preliminary study on the effect of functional food on body fat in human |
| Date of disclosure of the study information | 2018/07/24 |
| Last modified on | 2021/07/30 14:19:53 |
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Basic information
Public title
Preliminary study on the effect of functional food on body fat in human
Acronym
Preliminary study on the effect of functional food on body fat in human
Scientific Title
Preliminary study on the effect of functional food on body fat in human
Scientific Title:Acronym
Preliminary study on the effect of functional food on body fat in human
Region
| Japan |
Condition
Condition
Not applicable
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effect and safety of functional food on body fat in human.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Abdominal total fat area
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
3
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Functional food(low dose), 12 weeks
Interventions/Control_2
Functional food(high dose), 12 weeks
Interventions/Control_3
Food without functional food, 12 weeks
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Subject who is 20 years of age or older.
2) Subject, 23 kg/m2 <= BMI < 30 kg/m2.
3) Subject who is able to give written informed consent before the study.
Key exclusion criteria
(1)Subjects who are with treatment.
(2)Subjects who are with history of gastrointestinal surgery.
(3)Subjects who are attending other studies or attended other studies within the past 4 weeks.
(4)Subjects who are;
(a)With present heart disorder, liver disorder, or kidney disorder,
(b)With history of cardiac disorder,
(c)With diabetes mellitus, or
(d)With allergy to the study foods.
(5)Subjects who are not negative for syphilis, HBs antigen, HCV antibody or HIV antigen/antibody test.
(6)Subjects who are deemed to be unsuitable by the investigator.
Target sample size
90
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yuji Nonaka |
Organization
SUNTORY GLOBAL INNOVATION CENTER LIMITED
Division name
Research Institute
Zip code
Address
8-1-1 Seikadai, Seika-cho, Soraku-gun, Kyoto, Japan
TEL
050-3182-0587
Yuji_Nonaka@suntory.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kenji Yamamoto |
Organization
SUNTORY GLOBAL INNOVATION CENTER LIMITED
Division name
Research Institute
Zip code
Address
8-1-1 Seikadai, Seika-cho, Soraku-gun, Kyoto, Japan
TEL
050-3182-0594
Homepage URL
K_Yamamoto@suntory.co.jp
Sponsor or person
Institute
SUNTORY GLOBAL INNOVATION CENTER LIMITED
Institute
Department
Personal name
Funding Source
Organization
SUNTORY GLOBAL INNOVATION CENTER LIMITED
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
| 2018 | Year | 07 | 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
| 2018 | Year | 07 | Month | 11 | Day |
Date of IRB
| 2018 | Year | 07 | Month | 11 | Day |
Anticipated trial start date
| 2018 | Year | 07 | Month | 25 | Day |
Last follow-up date
| 2018 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 07 | Month | 18 | Day |
Last modified on
| 2021 | Year | 07 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038119
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
