UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055441 |
|---|---|
| Receipt number | R000063325 |
| Scientific Title | A study on the effect of intake of fermented tea made by mixing loquat leave containing salacia on visceral fat area |
| Date of disclosure of the study information | 2024/09/07 |
| Last modified on | 2025/02/28 10:56:33 |
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Basic information
Public title
A study on the effect of intake of fermented tea made by mixing loquat leave containing salacia on visceral fat area
Acronym
A study on the effect of intake of fermented tea made by mixing loquat leave containing salacia on visceral fat area
Scientific Title
A study on the effect of intake of fermented tea made by mixing loquat leave containing salacia on visceral fat area
Scientific Title:Acronym
A study on the effect of intake of fermented tea made by mixing loquat leave containing salacia on visceral fat area
Region
| Japan |
Condition
Condition
healthy people
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effect of long-term intake of fermented loquat leave powder containing salacia on suppressing visceral fat area
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
visceral fat area
Key secondary outcomes
waist circumference, weight, LDL-cholesterol, HDL-cholesterol, triglyceride, blood glucose
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
The subjects ingest the active meal for eight weeks.
Interventions/Control_2
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
| 70 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1)Healthy male and female between 20 and 70 years old
2)In principle, individuals with a visceral fat area of 60cm2 or more and a BMI of 23 to less than 30kg/m2
3) Individuals who can refrain from excessive eating and drinking during the study period
4) Individuals who have been fully explained the purpose and contents of the experiment, are capable of consenting, have a good understanding of the content, voluntally to participate, and agree to participate in the strudy in writing
5)Individuals who do not meet the exlusion criteria
Key exclusion criteria
1)Those suffering from or undergoing treatment for severe diabetes, kidney or liver disese
2)Those who are unable to stop consuming large amounts of green or black tea during the study period
3)Those who are unable to stop consuming medicines or supplements that may affect the evaluation items
4)Those who may be allergic to black or green tea
5)Those who become unwell when consuming caffeine
6)Alcoholics
7)Pregnant people, those who intend to become pregnant during the study period, and those who are breastfeeding
8)Those who are participating in or intend to participate in studies that involve the consumption of other foods or drugs, or studies that involve the application of cosmetics or drugs, etc.
9)Those who have difficulty filling out the subject diary
10)Those who are otherwise deemed unsuitable as subjects by the principal investigator
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Kazunari |
| Middle name | |
| Last name | Tanaka |
Organization
Univercity of Nagasaki
Division name
Regional Partnership Center
Zip code
8512195
Address
1-1-1 Manabino, Nagayo-cho, Nishisonogi-gun, Nagasaki, Japan, 851-2195
TEL
0958135216
katanaka@sun.ac.jp
Public contact
Name of contact person
| 1st name | Tetsuya |
| Middle name | |
| Last name | Yamaguchi |
Organization
Univercity of Nagasaki
Division name
Regional Partnership Center
Zip code
8512195
Address
1-1-1 Manabino, Nagayo-cho, Nishisonogi-gun, Nagasaki, Japan, 851-2195
TEL
0958135500
Homepage URL
tyamagu@sun.ac.jp
Sponsor or person
Institute
Univercity of Nagasaki
Institute
Department
Personal name
Funding Source
Organization
Sandai Co., LTD
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
Univercity of Nagasaki
Address
1-1-1 Manabino, Nagayo-cho, Nishisonogi-gun, Nagasaki, Japan, 851-2195
Tel
0958135500
tyamagu@sun.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 | 09 | Month | 07 | 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
24
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
| 2024 | Year | 08 | Month | 01 | Day |
Date of IRB
| 2024 | Year | 09 | Month | 03 | Day |
Anticipated trial start date
| 2024 | Year | 09 | Month | 07 | Day |
Last follow-up date
| 2025 | Year | 02 | Month | 28 | 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 | 09 | Month | 06 | Day |
Last modified on
| 2025 | Year | 02 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063325
