UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056251 |
|---|---|
| Receipt number | R000064267 |
| Scientific Title | Validation of a nutritional methods to enhance brown fat activity in young women |
| Date of disclosure of the study information | 2024/11/25 |
| Last modified on | 2025/05/26 12:43:01 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Validation of a nutritional methods to enhance brown fat activity in young women
Acronym
Validation of a nutritional methods to enhance brown fat activity in young women
Scientific Title
Validation of a nutritional methods to enhance brown fat activity in young women
Scientific Title:Acronym
Validation of a nutritional methods to enhance brown fat activity in young women
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The objective of this study is to identify methods to enhance impaired glucose metabolism and heat production in young women. In order to achieve this objective, the effects of matcha tea component intake on the thermogenic capacity of brown adipose tissue will be examined.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Brown fat activity
Key secondary outcomes
Body surface temperature at peripheral sites
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
3 g matcha powder (single oral intake)
Interventions/Control_2
3 g cornstarch (single oral intake)
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
| 18 | years-old | <= |
Age-upper limit
| 30 | years-old | > |
Gender
Female
Key inclusion criteria
Healthy young women
Key exclusion criteria
Experienced vasovagal reflex during blood collection and those with soy allergy
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Hirokazu |
| Middle name | |
| Last name | Taniguchi |
Organization
Kyoto Prefectural University
Division name
Graduate School of Life and Environmental Sciences
Zip code
606-8522
Address
1-5 Hangi-cho, Shimogamo, Sakyo-ku, Kyoto
TEL
075-703-5415
hirokazu-t@kpu.ac.jp
Public contact
Name of contact person
| 1st name | Hirokazu |
| Middle name | |
| Last name | Taniguchi |
Organization
Kyoto Prefectural University
Division name
Graduate School of Life and Environmental Sciences
Zip code
606-8522
Address
1-5 Hangi-cho, Shimogamo, Sakyo-ku, Kyoto
TEL
075-703-5415
Homepage URL
hirokazu-t@kpu.ac.jp
Sponsor or person
Institute
Kyoto Prefectural University
Institute
Department
Personal name
Funding Source
Organization
Matcha and Health Research
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
Kyoto Prefectural University Ethics Committee
Address
1-5 Hangi-cho, Shimogamo, Sakyo-ku, Kyoto
Tel
075-703-5101
kikaku@kpu.ac.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
| 2024 | Year | 11 | Month | 25 | 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
35
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
No longer recruiting
Date of protocol fixation
| 2024 | Year | 08 | Month | 21 | Day |
Date of IRB
| 2024 | Year | 10 | Month | 17 | Day |
Anticipated trial start date
| 2024 | Year | 11 | Month | 25 | Day |
Last follow-up date
| 2025 | Year | 01 | 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
| 2024 | Year | 11 | Month | 23 | Day |
Last modified on
| 2025 | Year | 05 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064267
