UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046535 |
|---|---|
| Receipt number | R000053050 |
| Scientific Title | A study to evaluate the effects of intake with food containing multiple ingredients on the reduction of including visceral fat-Randomized, double-blind, placebo-controlled parallel group study- |
| Date of disclosure of the study information | 2023/03/01 |
| Last modified on | 2024/03/11 09:54:22 |
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Basic information
Public title
A study to evaluate the effects of intake with food containing multiple ingredients on the reduction of including visceral fat-Randomized, double-blind, placebo-controlled parallel group study-
Acronym
A study to evaluate the effects of intake with food containing multiple ingredients on the reduction of including visceral fat
Scientific Title
A study to evaluate the effects of intake with food containing multiple ingredients on the reduction of including visceral fat-Randomized, double-blind, placebo-controlled parallel group study-
Scientific Title:Acronym
A study to evaluate the effects of intake with food containing multiple ingredients on the reduction of including visceral fat
Region
| Japan |
Condition
Condition
Not applicable
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate for reduction of Abdominal visceral fat and for safety when intake with food containing multiple ingredients for healthy adult men and women
Basic objectives2
Safety,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, Body weight, BMI, Body fat percentage, Waist circumference, Intestinal flora, Fecal organic acid, Breath gas (O2, CO2)
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
Intake of test food 1
Interventions/Control_2
Intake of test food 2
Interventions/Control_3
Intake of placebo food
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) Subjects with BMI >=23 kg/m2 and <30 kg/m2 at the time of screening test
3) Subjects who can visit on schedule days
4) Subjects who recognize the object and contents of the study and submit the written informed consent
Key exclusion criteria
1) Subjects who fall under the diagnostic criteria of metabolic syndrome
2) Subjects who are under treatment of liver disease, kidney disease, heart disease, respiratory disease, endocrine disease, metabolic disease, neurological disease, consciousness disease, diabetes disease, other disorders
3) Subjects who are have a history of cardiovascular disease
4) Subjects who do not intakecarbohydrates (rice, bread, noodles) for all three meals a day
5) Subjects who use oral medication or supplements which may affect this study
6) Subjects who are sensitive to medical products, and other foods
7) Subjects who have experienced sickness due to blood collection
8) Subjects who donated 200 mL or more of blood within 1 month from the start of the study or subjects who plan to do so during the study period
9) Subjects who participated in other clinical studies in the past 1 months
10) Subjects who usually intake heavy amount of alcohol (40g alcohol/day>=) and who are excessive smoker(21 cigarettes/day>=)
11) Subjects who with irregular eating habits. (Night shift worker)
12) Subjects who wish to become pregnant during the study periods( including the possibility of pregnant) or who are lactation.
13) Subjects who can not agree with preliminary explanation
14) Subjects who gained or lost 5% or more of weight within 6 month from the study
15) Subjects who are ineligible due to physician's judgment
Target sample size
81
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
New drug research center, Inc.
Division name
Clinical Research Dept.
Zip code
061-1405
Address
452-1 Toiso, Eniwa, Hokkaido, Japan
TEL
0123-34-0412
Homepage URL
t-ashino@ndrcenter.co.jp
Sponsor or person
Institute
New drug research center, Inc.
Institute
Department
Personal name
Funding Source
Organization
Fujifilm 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
Fukuhara Clinic Clinical Trial Review Committee
Address
3-1-15 Shimamatsuhigashi-machi, Eniwa, Hokkaido, Japan
Tel
0123-36-8029
d-kameda@mediffom.co.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
| 2023 | Year | 03 | Month | 01 | 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 | 12 | Month | 07 | Day |
Date of IRB
| 2021 | Year | 12 | Month | 13 | Day |
Anticipated trial start date
| 2022 | Year | 01 | Month | 07 | Day |
Last follow-up date
| 2022 | Year | 03 | Month | 26 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2022 | Year | 01 | Month | 04 | Day |
Last modified on
| 2024 | Year | 03 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053050
