UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000051338 |
|---|---|
| Receipt number | R000058567 |
| Scientific Title | Exploratory study of the effects of foods containing plant-derived ingredients on metabolite changes in human |
| Date of disclosure of the study information | 2023/06/18 |
| Last modified on | 2025/01/06 15:14:56 |
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Basic information
Public title
Exploratory study of the effects of foods containing plant-derived ingredients on metabolite changes in human (SWE-2023-04-HBKS)
Acronym
Exploratory study of the effects of foods containing plant-derived ingredients on metabolite changes in human
Scientific Title
Exploratory study of the effects of foods containing plant-derived ingredients on metabolite changes in human
Scientific Title:Acronym
Exploratory study of the effects of foods containing plant-derived ingredients on metabolite changes in human
Region
| Japan |
Condition
Condition
Not applicable
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effects of food ingredients on metabolite changes in human
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Blood metabolites
Key secondary outcomes
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
4
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Intake of the test foods (low dose) for 4 weeks, washout for 4 weeks, then intake of the control foods for 4 weeks.
Interventions/Control_2
Intake of the control foods for 4 weeks, washout for 4 weeks, then intake of the test foods (low dose) for 4 weeks.
Interventions/Control_3
Intake of the test foods (high dose) for 4 weeks, washout for 4 weeks, then intake of the control foods for 4 weeks.
Interventions/Control_4
Intake of the control foods for 4 weeks, washout for 4 weeks, then intake of the test foods (high dose) for 4 weeks.
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 40 | years-old | <= |
Age-upper limit
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1) Healthy men and women aged 40 less than 65 years
2) 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 are receiving some kind of treatment at the time of obtaining consent to participate in the study.
2) Subjects who keep irregular hours such as shift work.
3) Heavy drinker of alcohol.
4) Use of products affecting the data of this study, such as food for specified health use, food with function claims, and medicine.
5) Investigator's judgment for other reason.
Target sample size
240
Research contact person
Name of lead principal investigator
| 1st name | Daisuke |
| Middle name | |
| Last name | Takemoto |
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
050-3182-0661
Daisuke_Takemoto@suntory.co.jp
Public contact
Name of contact person
| 1st name | Kenichi |
| Middle name | |
| Last name | Wakabayashi |
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
050-3182-0599
Homepage URL
Kenichi_Wakabayashi@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
Ueno-Asagao Clinic Ethical Review Committee
Address
6F Kairaku Building 2-7-5 Higashiueno Taito-ku Tokyo 110-0015, JAPAN
Tel
03-6240-1162
info@ueno-asagao.clinic
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 | 06 | Month | 18 | 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 | 04 | Month | 25 | Day |
Date of IRB
| 2023 | Year | 04 | Month | 20 | Day |
Anticipated trial start date
| 2023 | Year | 06 | Month | 19 | Day |
Last follow-up date
| 2023 | Year | 10 | Month | 14 | 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 | 06 | Month | 14 | Day |
Last modified on
| 2025 | Year | 01 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000058567
