Unique ID issued by UMIN | UMIN000053745 |
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Receipt number | R000061320 |
Scientific Title | Verification of the effects of long-term intake of test food on lipid metabolism : Placebo-controlled, double-blind, randomized, parallel-group comparison study |
Date of disclosure of the study information | 2024/03/03 |
Last modified on | 2024/03/01 11:05:04 |
Verification of the effects of long-term intake of test food on lipid metabolism
Verification of the effects of long-term intake of test food on lipid metabolism
Verification of the effects of long-term intake of test food on lipid metabolism
: Placebo-controlled, double-blind, randomized, parallel-group comparison study
Verification of the effects of long-term intake of test food on lipid metabolism
: Placebo-controlled, double-blind, randomized, parallel-group comparison study
Japan |
Healthy adults
Adult |
Others
NO
Ingest the test food for 12 weeks and verify the effect on the lipid metabolism during exercise.
Efficacy
LDL cholesterol
Total cholesterol
HDL cholesterol
Oxidized LDL
Triglycerides
Free fatty acid
Lipase
Lipid peroxide
Malondialdehyde
Smart Analysis of Thrombin Production for Tissue Factor
Interventional
Parallel
Randomized
Individual
Double blind -all involved are blinded
Placebo
2
Prevention
Food |
Ingestion of test food for 12 weeks
Ingestion of placebo food for 12 weeks
20 | years-old | <= |
64 | years-old | >= |
Male and Female
(1) Subjects of men and women aged 20 to 64
(2) Subjects with LDL cholesterol of 120-139 md/dL or 140-159 mg/dL
(3) Subjects who received sufficient explanation about the purpose and content of the test, had the ability to consent, voluntarily volunteered to participate after understanding it well, and agreed to participate in the test in writing.
(1) Subjects with a history of diabetes, liver diseases, cardiac disease, respiratory disease, peripheral vascular disease, or other serious disease.
(2) Subjects who have undergone gastrointestinal surgery
(3) Subjects with abnormal liver and renal function test value
diabetes
(4) Subjects with diseases currently being treated
(5) Subjects who are allergic to food and drugs
(6) Subjects with anemia symptoms
(7) Female subjects wishing to become pregnant while participating in this study, pregnant (including those who may be pregnant) or lactating female subjects
(8) Those who play intense sports and subjects who are on a diet
(9) Subjects with extremely irregular eating habits
(10) Subjects who cannot stop taking health foods (including foods for specified health use and foods with functional claims) and quasi-drugs during the test period
(11) Subjects who are continuously treated with pharmaceuticals (including OTC and prescription drugs)
(12) Subjects who drink more than 20 g of average daily pure alcohol
(13) Subjects who smoke an average of 21 or more cigarettes a day
(14) Subjects who are participating in or will participate in other clinical trials at the start of this study.
(15) Other subjects judged by the investigator or the investigator to be inappropriate for the examination
80
1st name | Naoki |
Middle name | |
Last name | Miura |
Miura Clinic, Medical Corporation Kanonkai
Internal medicine
5300044
Higashitenma building 9F, 1-7-17, Higashitenma, Kita-ku, Osaka
06-6135-5200
info@miura-cl.jp
1st name | Makoto |
Middle name | |
Last name | Terashima |
Oneness Support Co., Ltd.
Clinical Trial Division
5300044
Higashitenma building 4F, 1-7-17, Higashitenma, Kita-ku, Osaka
06-4801-8917
mterashima@oneness-sup.co.jp
Miura Clinic, Medical Corporation Kanonkai
TOWA PHARMACEUTICAL CO.,LTD
Profit organization
The Ethics Committee of Miura Clinic, Medical Corporation Kanonkai
Higashitenma building 9F, 1-7-17, Higashitenma, Kita-ku, Osaka
06-6135-5200
mterashima@miura-cl.jp
NO
医療法人花音会みうらクリニック(大阪府)
2024 | Year | 03 | Month | 03 | Day |
Unpublished
Preinitiation
2024 | Year | 02 | Month | 22 | Day |
2024 | Year | 02 | Month | 29 | Day |
2024 | Year | 04 | Month | 11 | Day |
2024 | Year | 06 | Month | 30 | Day |
2024 | Year | 03 | Month | 01 | Day |
2024 | Year | 03 | Month | 01 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000061320
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