UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045543 |
|---|---|
| Receipt number | R000052000 |
| Scientific Title | Examination of changes in visceral fat area due to long-term intake of test foods. Randomized, single-blind, placebo-controlled, parallel-group controlled trial |
| Date of disclosure of the study information | 2021/09/24 |
| Last modified on | 2022/09/26 16:59:41 |
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Basic information
Public title
Effect of test food on visceral fat area. (pilot study)
Randomized, single-blind, placebo-controlled, parallel-group controlled trial
Acronym
Effect of test food on visceral fat area.
Scientific Title
Examination of changes in visceral fat area due to long-term intake of test foods.
Randomized, single-blind, placebo-controlled, parallel-group controlled trial
Scientific Title:Acronym
Examination of changes in visceral fat area due to long-term intake of test foods
Region
| Japan |
Condition
Condition
Healthy volunteer
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Examination of changes in visceral fat area due to long-term intake of test food
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Abdominal visceral fat area (VFA)
Time;0w, 8w, 16w, 24w
Key secondary outcomes
Total abdominal fat area
Abdominal subcutaneous fat area
Body weight
BMI
Waist circumference
Hip circumference
Waist circumference / Hip circumference
Time:0w, 8w, 16w, 24w
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants 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
Test Food
Period:24 weeks
Interventions/Control_2
Control Food (Placebo)
Period:24 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
| 30 | years-old | <= |
Age-upper limit
| 74 | years-old | >= |
Gender
Male
Key inclusion criteria
1. Age:30 to 74 years old
2. Healthy men
3. BMI: 23-30 kg/m^2
Key exclusion criteria
1.Subjects with a history of serious illness
2.Subjects with inborn errors of amino acid metabolism
3.Subjects who are on medication for diabetes
4.Subjects with diseases that require treatment or medication that affect the study
5.Subjects with regularly use medicines and health foods that affect research
6.Subjects with significant weight changes within the last 6 months (plus or minus 10% or more)
7.Subjects with food allergy to test food
8.Subjects who consume a large amount of alcohol on a daily basis (pure alcohol 60 g/day or more)
9.Subjects who have participated in or are willing to participate in clinical trial
10.Subjects judged as unsuitable for the study by the responsible doctor for other reasons
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Kei |
| Middle name | |
| Last name | Yui |
Organization
FANCL Corporation
Division name
Research Institute, Health science research center
Zip code
244-0806
Address
12-13, Kamishinano, Totsuka-ku, Yokohama, Kanagawa
TEL
045-820-3443
ke-yui@fancl.co.jp
Public contact
Name of contact person
| 1st name | Akiko |
| Middle name | |
| Last name | Goto |
Organization
Kenkoin Medical Corporation Foundation
Division name
Kenkoin Clinic
Zip code
104-0061
Address
6-7-4 Ginza, Chuo-ku, Tokyo
TEL
03-3573-1153
Homepage URL
akiko-goto@kenkoin.jp
Sponsor or person
Institute
FANCL Corporation
Institute
Department
Personal name
Funding Source
Organization
FANCL 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
Kenkoin Medical Corporation Foundation Clinical Research Ethics Committee
Address
6-7-4 Ginza, Chuo-ku, Tokyo
Tel
03-3573-1153
isamu-yanase@kenkoin.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
医療法人財団健康院 健康院クリニック（東京都）
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 09 | 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
| 2021 | Year | 08 | Month | 25 | Day |
Date of IRB
| 2021 | Year | 08 | Month | 31 | Day |
Anticipated trial start date
| 2021 | Year | 09 | Month | 28 | Day |
Last follow-up date
| 2022 | Year | 05 | Month | 15 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2021 | Year | 09 | Month | 22 | Day |
Last modified on
| 2022 | Year | 09 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052000
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
