UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052759 |
|---|---|
| Receipt number | R000060203 |
| Scientific Title | Phase II study to examine the efficacy and safety of Awa Suzuka extracted ingredients |
| Date of disclosure of the study information | 2023/11/10 |
| Last modified on | 2023/11/10 16:33:00 |
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Basic information
Public title
Study to examine the efficacy and safety of Awa Suzuka extracted ingredients
Acronym
Awa Suzuka Efficacy Test
Scientific Title
Phase II study to examine the efficacy and safety of Awa Suzuka extracted ingredients
Scientific Title:Acronym
Phase II study of Awa Suzuka extracted ingredients
Region
| Japan |
Condition
Condition
Healthy subjects with serum triglyceride levels in the borderline range
Classification by specialty
| Medicine in general |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy and safety of Awa Suzuka peel powder intake in healthy individuals with serum triglyceride levels in the borderline range.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
Serum triglyceride level
Key secondary outcomes
Body Fat Percentage
body weight
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
NO
Dynamic allocation
NO
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Specifics of the intervention act (4 tablets/day of tabletized powder, administration period of 30 days)
Criteria for implementation of the intervention; ingestion after breakfast
Criteria for modification of the intervention; discontinuation of the intervention if any discomfort (diarrhea or other gastrointestinal symptoms, mood disorder, allergic symptoms, etc.) occurs due to ingestion
Criteria for discontinuation or completion of the intervention (prophylaxis, medication, testing, etc.); discontinuation if any intake-related discomfort (diarrhea or other gastrointestinal symptoms, dysphoria, allergic symptoms, etc.) occurs
Interventions/Control_2
Specifics of the intervention act (4 tablets/day of tabletized powder, administration period of 30 days)
Criteria for implementation of the intervention; ingestion after breakfast
Criteria for modification of the intervention; discontinuation of the intervention if any discomfort (diarrhea or other gastrointestinal symptoms, mood disorder, allergic symptoms, etc.) occurs due to ingestion
Criteria for discontinuation or completion of the intervention (prophylaxis, medication, testing, etc.); discontinuation if any intake-related discomfort (diarrhea or other gastrointestinal symptoms, dysphoria, allergic symptoms, etc.) occurs
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
| 64 | years-old | > |
Gender
Male and Female
Key inclusion criteria
People with triglyceride levels in the 120-149 mg/dL range
Key exclusion criteria
Persons with diseases of the liver, kidney, heart, etc.
Those who are taking medication for the purpose of treatment of diseases such as lifestyle-related diseases
Those who have taken supplements within 1 month of the start of the study
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Hiroshi |
| Middle name | |
| Last name | Sakaue |
Organization
Tokushima University Graduate School
Division name
Institute of Biomedical sciences
Zip code
7708503
Address
3-18-15 Kuramoto-cho, Tokushima
TEL
0886339249
hsakaue@tokushima-u.ac.jp
Public contact
Name of contact person
| 1st name | Hirohshi |
| Middle name | |
| Last name | Sakaue |
Organization
Tokushima University Graduate Schoo
Division name
Institute of Biomedical sciences
Zip code
7708503
Address
3-18-15 Kuramoto-cho, Tokushima
TEL
0886339249
Homepage URL
hsakaue@tokushima-u.ac.jp
Sponsor or person
Institute
Tokushima University Graduate School
Institute
Department
Personal name
Funding Source
Organization
Japan Science and Technology Agency
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The Ethics Committee of Tokushima University Hospital
Address
2-50-1 Kuramoto-cho, Tokushima
Tel
0886339295
awachiken@tokushima-u.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
徳島大学
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 11 | Month | 10 | 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
Preinitiation
Date of protocol fixation
| 2023 | Year | 11 | Month | 10 | Day |
Date of IRB
Anticipated trial start date
| 2023 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 11 | Month | 30 | 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 | 11 | Month | 10 | Day |
Last modified on
| 2023 | Year | 11 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000060203
