Unique ID issued by UMIN | UMIN000055008 |
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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 | 2024/07/18 11:14:17 |
Randomized, double-blind, placebo-controlled parallel-group comparative study to evaluate the efficacy of the fermented vinegar drink on reducing triglyceride in adults
A clinical trial of the fermented vinegar drink on reducing triglyceride in adults
Randomized, double-blind, placebo-controlled parallel-group comparative study to evaluate the efficacy of the fermented vinegar drink on reducing triglyceride in adults
A clinical trial of the fermented vinegar drink on reducing triglyceride in adults
Japan |
None(Healthy adult)
Not applicable | Adult |
Others
NO
To evaluate the reduction effect of triglyceride by prolonged intake of the fermented vinegar drink in adults.
Safety,Efficacy
Serum triglyceride
BMI
Body fat percentage
POMS2 adult shortening version
Interventional
Parallel
Randomized
Individual
Double blind -all involved are blinded
Placebo
2
Prevention
Food |
Ingest the test food for 8 weeks
Ingest the placebo food for 8 weeks
20 | years-old | <= |
64 | years-old | >= |
Male and Female
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
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
100
1st name | Yoshihiro |
Middle name | |
Last name | lzumi |
NIHONBASHI CLOUD CLINIC
director
103-0027
Nihonbashi2-16-3 Chuo-ku, Tokyo, Japan
03-6824-5448
yoshihiro.lzumi@jmintegral.com
1st name | Shigeru |
Middle name | |
Last name | Imai |
Leverage Brain Inc.
Clinical Trial Department
150-0002
Shibuya 1-4-7 Shibuya-ku, Tokyo, Japan
080-7290-0404
imai@levbrain.com
Leverage Brain Inc.
Morinaga Milk Industry Co., Ltd.
Profit organization
Japan Conference of Clinical Research
1-13-23 Minamiikebukuro Toshima-ku, Tokyo, Japan
03-6868-7022
jccr-info@cts-smo.com
NO
日本橋クラウドクリニック(東京都)
NIHONBASHI CLOUD CLINIC (Tokyo, Japan)
2024 | Year | 07 | Month | 26 | Day |
Unpublished
Preinitiation
2024 | Year | 07 | Month | 05 | Day |
2024 | Year | 07 | Month | 25 | Day |
2024 | Year | 07 | Month | 26 | Day |
2024 | Year | 12 | Month | 30 | Day |
2024 | Year | 07 | Month | 18 | Day |
2024 | Year | 07 | Month | 18 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000062842
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