UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055008 |
|---|---|
| Receipt number | R000062842 |
| Scientific Title | Randomized, double-blind, placebo-controlled parallel-group comparative study to evaluate the efficacy of the fermented vinegar drink on reducing triglyceride in adults |
| Date of disclosure of the study information | 2024/07/26 |
| Last modified on | 2025/08/25 09:59:13 |
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Basic information
Public title
Randomized, double-blind, placebo-controlled parallel-group comparative study to evaluate the efficacy of the fermented vinegar drink on reducing triglyceride in adults
Acronym
A clinical trial of the fermented vinegar drink on reducing triglyceride in adults
Scientific Title
Randomized, double-blind, placebo-controlled parallel-group comparative study to evaluate the efficacy of the fermented vinegar drink on reducing triglyceride in adults
Scientific Title:Acronym
A clinical trial of the fermented vinegar drink on reducing triglyceride in adults
Region
| Japan |
Condition
Condition
None(Healthy adult)
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the reduction effect of triglyceride by prolonged intake of the fermented vinegar drink in adults.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Serum triglyceride
Key secondary outcomes
BMI
Body fat percentage
POMS2 adult shortening version
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
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Ingest the test food for 8 weeks
Interventions/Control_2
Ingest the placebo food for 8 weeks
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
1) Age is between 20 and 64 years old
2) Subjects with a BMI of >= 23 kg/ m2 and <30 kg/m2
3) Subjects with fasting TG levels between 120 and 199 mg/dL at the time of screening
Key exclusion criteria
1) Subjects with serious hepatic, kidney, cardiac, digestive, brain, endocrine metabolic s, or infectious diseases or with a medical history of these disorders
2) Subjects regularly taking medications that affect obesity, hyperlipidemia, lipid metabolism, or the intestinal environment during the study period
3) Subjects who cannot stop taking health foods or supplements that affect obesity, hyperlipidemia, lipid metabolism, or the intestinal environment during the study period.
4) Heavy smokers
5) Consumption of excessive alcohol (More than 60g of pure alcohol/ day)
6) Subjects with severe drug or food allergies
7) Subjects with lactose intolerance or who experience gastrointestinal or abdominal symptoms when consuming milk
8) Subjects who are pregnant or lactating, or who are planning to become pregnant during the study
9) Subjects who have participated in other clinical trials within 3 months of consent or who plan to participate in other clinical trials during the study period
10) Subjects deemed ineligible for participation by the investigator
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Yoshihiro |
| Middle name | |
| Last name | lzumi |
Organization
NIHONBASHI CLOUD CLINIC
Division name
director
Zip code
103-0027
Address
Nihonbashi2-16-3 Chuo-ku, Tokyo, Japan
TEL
03-6824-5448
yoshihiro.lzumi@jmintegral.com
Public contact
Name of contact person
| 1st name | Shigeru |
| Middle name | |
| Last name | Imai |
Organization
Leverage Brain Inc.
Division name
Clinical Trial Department
Zip code
150-0002
Address
Shibuya 1-4-7 Shibuya-ku, Tokyo, Japan
TEL
080-7290-0404
Homepage URL
imai@levbrain.com
Sponsor or person
Institute
Leverage Brain Inc.
Institute
Department
Personal name
Funding Source
Organization
Morinaga Milk Industry 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
Japan Conference of Clinical Research
Address
1-13-23 Minamiikebukuro Toshima-ku, Tokyo, Japan
Tel
03-6868-7022
jccr-info@cts-smo.com
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
日本橋クラウドクリニック（東京都）
NIHONBASHI CLOUD CLINIC (Tokyo, Japan)
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 07 | Month | 26 | 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
| 2024 | Year | 07 | Month | 05 | Day |
Date of IRB
| 2024 | Year | 07 | Month | 25 | Day |
Anticipated trial start date
| 2024 | Year | 07 | Month | 26 | Day |
Last follow-up date
| 2024 | Year | 12 | Month | 30 | Day |
Date of closure to data entry
| 2025 | Year | 01 | Month | 15 | Day |
Date trial data considered complete
| 2025 | Year | 03 | Month | 01 | Day |
Date analysis concluded
| 2025 | Year | 03 | Month | 28 | Day |
Other
Other related information
Management information
Registered date
| 2024 | Year | 07 | Month | 18 | Day |
Last modified on
| 2025 | Year | 08 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062842
