UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000059192 |
|---|---|
| Receipt number | R000067624 |
| Scientific Title | A study to examine the effects of intake of a capsule containing multi-ingredient(FD-2553) on fat metabolism |
| Date of disclosure of the study information | 2025/11/30 |
| Last modified on | 2025/09/24 11:36:02 |
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Basic information
Public title
A study to examine the effects of intake of a capsule containing multi-ingredient(FD-2553) on fat metabolism
Acronym
A study to examine the effects of intake of a capsule containing multi-ingredient(FD-2553) on fat metabolism
Scientific Title
A study to examine the effects of intake of a capsule containing multi-ingredient(FD-2553) on fat metabolism
Scientific Title:Acronym
A study to examine the effects of intake of a capsule containing multi-ingredient(FD-2553) on fat metabolism
Region
| Japan |
Condition
Condition
Healthy volunteers
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the effects of intake of the test food on fat metabolism
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Fat metabolism equivalent to physical activity intensity
Key secondary outcomes
Respiratory quotient
Base
Study type
Interventional
Study design
Basic design
Cross-over
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
Prevention
Type of intervention
| Food |
Interventions/Control_1
Single intake of the test food -> washout period (1 week) -> Single intake of the placebo
Interventions/Control_2
Single intake of the placebo -> washout period (1 week) -> Single intake of the test food
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
| 45 | years-old | >= |
Gender
Male
Key inclusion criteria
1)Male whose age of 20 to 45
2)Person whose BMI of 18.5 kg/m2 or more and less than 25.0 kg/m2
3)Person with no regular exercise habit of twice a week or more
4)Person receiving sufficient briefing of the objective and content of the present study, fully understanding and agreeing to voluntarily participate in the study and being able to personally sign a written informed consent
5)Person who can have examinations at the specified date
Key exclusion criteria
1)Person receiving a medical treatment for serious cardio-vascular, hepatic, renal, respiratory, endocrine or metabolic disorders or having a medical history of these disorders
2)Person having a medical history of chest pain or syncope
3)Person having low back pain, arthralgia, lumber hernia, disease of lower limbs or palpitations
4)Person who may have allergic symptoms to the test food or standardized diet
5)Person having moderate or more allergic rhinitis
6)Person who regularly take medicines and quasi-drugs that affect energy metabolism
7)Person who regularly take Foods with Function Claims indicating functions that affect energy metabolism
8)Person who have a smoking habit (including heated tobacco and electronic cigarettes)
9)Person who consume excessive alcohol (equivalent to an average of 40 g or more of pure alcohol per day)
10)Person who restrict carbohydrates intake
11)Person working night shift or day-night shift
12)Person who have donated more than 200 ml of blood within 1 month, or more than 400 ml within 3 months prior to the start of the present study
13)Person who took part in another clinical study within 3 months prior to the start of the present study or who is currently taking part in another clinical study
14)Person deemed unsuitable by the investigator
Target sample size
24
Research contact person
Name of lead principal investigator
| 1st name | Takashi |
| Middle name | |
| Last name | Tagawa |
Organization
Maruzen Pharmaceuticals Co., Ltd
Division name
Research & Development Division
Zip code
729-3102
Address
1089-8, Shinichi-cho Sagata, Fukuyama, Hiroshima
TEL
0847-52-6262
t-tagawa@maruzenpcy.co.jp
Public contact
Name of contact person
| 1st name | Tomohiro |
| Middle name | |
| Last name | Sugino |
Organization
Soiken Inc.
Division name
R&D Division
Zip code
560-0082
Address
Senri Life Science Center 13F, 1-4-2, Shinsenri-higashimachi, Toyonaka, Osaka
TEL
06-6871-8888
Homepage URL
sugino@soiken.com
Sponsor or person
Institute
Maruzen Pharmaceuticals Co., Ltd
Institute
Department
Personal name
Funding Source
Organization
None
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
IRB of Fukuda Clinic
Address
Shin-Osaka brick building 2F, 1-6- 1 Miyahara, Yodogawa, Osaka, Osaka
Tel
06-6398-0203
fukudaclinicIRB@gmail.com
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
| 2025 | Year | 11 | Month | 30 | 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
| 2025 | Year | 08 | Month | 16 | Day |
Date of IRB
| 2025 | Year | 08 | Month | 16 | Day |
Anticipated trial start date
| 2025 | Year | 12 | Month | 04 | Day |
Last follow-up date
| 2025 | 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
| 2025 | Year | 09 | Month | 25 | Day |
Last modified on
| 2025 | Year | 09 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000067624
