UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000051748 |
|---|---|
| Receipt number | R000059061 |
| Scientific Title | A study to evaluate the dose-response efficacy of body fat reduction by continuous ingestion of test food. (SWE-2023-07-HCRINK) |
| Date of disclosure of the study information | 2023/07/30 |
| Last modified on | 2024/05/08 09:07:24 |
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Basic information
Public title
A study to evaluate the dose-response efficacy of body fat reduction by continuous ingestion of test food. (SWE-2023-07-HCRINK)
Acronym
A study to evaluate the dose-response efficacy of body fat reduction by continuous ingestion of test food.
Scientific Title
A study to evaluate the dose-response efficacy of body fat reduction by continuous ingestion of test food. (SWE-2023-07-HCRINK)
Scientific Title:Acronym
A study to evaluate the dose-response efficacy of body fat reduction by continuous ingestion of test food.
Region
| Japan |
Condition
Condition
Not applicable
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the dose-response efficacy of body fat reduction by continuous ingestion of test food.
Basic objectives2
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
4
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Intake of the high-dose test foods for 12 weeks.
Interventions/Control_2
Intake of the medium-dose test foods for 12 weeks.
Interventions/Control_3
Intake of the low-dose test foods for 12 weeks.
Interventions/Control_4
Intake of the control foods for 12 weeks.
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 who are 20 -< years old < 65 from the time of IC acquisition to the end of the study.
(2) Subjects who can come to the designated premises on the date of the scheduled visit.
(3) Subjects who can understand the purpose and content of this study and agree in writing to participate in this study.
Key exclusion criteria
(1) Subjects who have regular hard exercise.
(2) Heavy drinker of alcohol and heavy smoker
(3) Subjects who use of products affecting the data of this study, such as food for specified health use, and food with function claims.
(4) Subjects who continuously take medicines.
(5) Subjects who are participating in other study or planning to participate or participated within the past 4 weeks.
(6) Subjects who are:
a) heart, liver, or kidney disease (including complications of other diseases)
b) undergoing treatment for or have a history of cardiovascular disease
c) diabetes
d) allergic to test foods
e) undergoing treatment for or have a history of serious diseases such as cancer or tuberculosis
f) having history of comorbidities in the gastrointestinal tract (excluding a history of cecum)
(7) Others who are judged inappropriate for participant by the investigator
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Hidenori |
| Middle name | |
| Last name | Obata |
Organization
Suntory Wellness Limited
Division name
Institute for Science of Life
Zip code
619-0284
Address
8-1-1 Seikadai, Seika-cho, Soraku-gun, Kyoto. 619-0284, Japan
TEL
050-3182-0568
Hidenori_Obata@suntory.co.jp
Public contact
Name of contact person
| 1st name | Mui |
| Middle name | |
| Last name | Iida |
Organization
Suntory Wellness Limited
Division name
Institute for Science of Life
Zip code
619-0284
Address
8-1-1 Seikadai, Seika-cho, Soraku-gun, Kyoto. 619-0284, Japan
TEL
050-1734-9361
Homepage URL
Mui_Iida@suntory.co.jp
Sponsor or person
Institute
Suntory Wellness Limited
Institute
Department
Personal name
Funding Source
Organization
Suntory Wellness Limited
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 IRB
Address
5th floor of the Ito-Yokado Fukuzumi store, 2-1-2-5 Fukuzumi, Toyohira-ku, Sapporo-shi, Hokkaido
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
| 2023 | Year | 07 | 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
Completed
Date of protocol fixation
| 2023 | Year | 07 | Month | 29 | Day |
Date of IRB
| 2023 | Year | 07 | Month | 28 | Day |
Anticipated trial start date
| 2023 | Year | 07 | Month | 31 | Day |
Last follow-up date
| 2023 | Year | 12 | Month | 16 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2023 | Year | 07 | Month | 29 | Day |
Last modified on
| 2024 | Year | 05 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000059061
