UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000060853 |
|---|---|
| Receipt number | R000069623 |
| Scientific Title | Investigation of the effects of Food Containing Multiple Ingredients (FD-2553) on abdominal fat-Randomized, placebo-controlled, double-blind, parallel group study- |
| Date of disclosure of the study information | 2026/03/06 |
| Last modified on | 2026/03/06 17:59:22 |
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Basic information
Public title
Investigation of the effects of Food Containing Multiple Ingredients (FD-2553) on abdominal fat-Randomized, placebo-controlled, double-blind, parallel group study-
Acronym
Investigation of the effects of Food Containing Multiple Ingredients (FD-2553) on abdominal fat
Scientific Title
Investigation of the effects of Food Containing Multiple Ingredients (FD-2553) on abdominal fat-Randomized, placebo-controlled, double-blind, parallel group study-
Scientific Title:Acronym
Investigation of the effects of Food Containing Multiple Ingredients (FD-2553) on abdominal fat
Region
| Japan |
Condition
Condition
Healthy volunteer
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate for effects of abdominal fat reduction when supplementing with Food Ingredient Mixture (FD-2553) for 12 weeks in adult males and females with BMI of 23.0-29.9 kg/m^2
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Abdominal visceral fat area
Key secondary outcomes
Abdominal total fat area, abdominal subcutaneous fat area, body weight, BMI, body composition analysis, waist circumference, total cholesterol, LDL-cholesterol, HDL-cholesterol, triglyceride, glucose, HbA1c, blood ketone
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
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Intake of active 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 aged of 20-64 years
2)Participants whose BMI 23.0-29.9 kg/m^2
3)Participants who can visit on schedule days
4)Participants who recognize the object and contents of the study and submit the written informed consent
Key exclusion criteria
1)Participants who are under treatment or have a history of severe illness in the heart, liver, kidney, digestive organs or other organs
2)Participants who have been diagnosed with, or have a past medical history of dyslipidemia, high blood pressure, or diabetes
3)Participants with a condition that may affect body weight or body fat
4)Participants who joined a weight loss program or similar initiative within three months prior to the start of the screening examination, or participants who experienced significant weight change (a change of 5 kg or more)
5)Participants who received medication treatment or surgery due to serious illness or injury within 1 month prior to the start of this study
6)Participants who regularly use health foods and supplements affecting the study
7)Participants who may have difficulties during CT scanning (e.g. claustrophobia, metal in the vicinity of imaging, implanted medical devices in the body)
8)Possible pregnancy, pregnancy and lactation
9)Heavy drinker (40g alcohol/day or more)
10)Excessive smokers (21 cigarettes/day or more)
11)Participants who feel bad mood by blood collect
12)Participants who donated 200 mL or more of blood within 1 month prior to the start of screening tests or participants who plan to do so during the study period
13)Participants who have been diagnosed with chronic constipation
14)Late-night shift worker
15)Participants who plan business trip or other travel averaging more than 10 days per month
16)Participants who have allergies related to the test foods
17)Participants already participating in other clinical trials, or who plan to participate in other clinical trials during the study period
18)Participants who are ineligible due to physician's judgment
Target sample size
104
Research contact person
Name of lead principal investigator
| 1st name | Ikuo |
| Middle name | |
| Last name | Fukuhara |
Organization
Fukuhara Clinic
Division name
Hospital director
Zip code
061-1351
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 | Toyotada |
| Middle name | |
| Last name | Ashino |
Organization
Trans Genic Inc.
Division name
Clinical Research Department
Zip code
061-1405
Address
452-1 Toiso,Eniwa,Hokkaido,Japan
TEL
0123-34-0412
Homepage URL
toyotada.ashino@transgenic.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
Medical Corporation Jikokai Fukuzumi Internal Medicine Clinic Clinical Trial Review Committee
Address
1-2-5 Fukuzumi-2jo, Toyohira-ku, Sapporo, Hokkaido, Japan
Tel
011-836-3531
shibata@jkkai.or.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
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 03 | 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
Preinitiation
Date of protocol fixation
| 2026 | Year | 02 | Month | 20 | Day |
Date of IRB
| 2026 | Year | 03 | Month | 02 | Day |
Anticipated trial start date
| 2026 | Year | 04 | Month | 24 | Day |
Last follow-up date
| 2026 | Year | 08 | Month | 08 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2026 | Year | 03 | Month | 06 | Day |
Last modified on
| 2026 | Year | 03 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000069623
