Unique ID issued by UMIN | UMIN000023894 |
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Receipt number | R000027521 |
Scientific Title | The verification study for blood lipid reduction effects: a randomized, double-blind, controlled trial |
Date of disclosure of the study information | 2016/09/01 |
Last modified on | 2017/05/02 12:41:23 |
The verification study for blood lipid reduction effects: a randomized, double-blind, controlled trial
The verification study for blood lipid reduction effects
The verification study for blood lipid reduction effects: a randomized, double-blind, controlled trial
The verification study for blood lipid reduction effects
Japan |
Healthy adults
Not applicable | Adult |
Others
NO
To verify the LDL-cholesterol reduction effects due to the ingestion of the test material.
Safety,Efficacy
Confirmatory
Not applicable
1. LDL-cholesterol
*1 Take the blood samples at 0 week and 12 weeks after the ingestion
1. Total cholesterol, HDL-cholesterol, LDL/HDL ratio, triglyceride (TG), glucose, HbA1c, and glycoalbumin
*1 Take the blood samples at 0 week and 12 weeks after the ingestion
2. Body weight, BMI, and body fat percentage
*2 Take the measurements at 0 week and 12 weeks after the ingestion
Interventional
Parallel
Randomized
Individual
Double blind -all involved are blinded
Placebo
2
Treatment
Food |
Duration: 12 weeks
Test material: "health beverage"
Administration: Drink it at any time of a day
Duration: 12 weeks
Test material: "Placebo beverage"
Administration: Drink it at any time of a day
20 | years-old | <= |
Not applicable |
Male and Female
1. Healthy Japanese adults of 20 years old or more
2. LDL-cholesterol levels were higher in the boundary region at most recent medical check-up
1. At least one previous medical history of malignant tumor, heart failure or myocardial infarction
2. Currently under the treatment for either cardiac arrhythmia, hepatic disorder, renal disorder, cerebrovascular disorder, rheumatism, diabetes mellitus, dyslipidemia, hypertension or other chronic diseases
3. Currently taking medicines and/or herbal medicines
4. Those who eat Food with Functional Claims of the LDL-cholesterol reduction effects and drink beverage with related to vinegar on a daily basis
5. Those who eat and/or drink Food for Specified Health Uses and/or Food with Function Claims on a daily basis
6. Allergic to medicines or foods related to the test food of this trial
7. Pregnant, lactating, or planning to get pregnant during the trial period
8. Enrolled into other clinical trials within the last 3 months before agreeing to participate in this trial
9. Judged unsuitable for participating in this trial by physician
14
1st name | |
Middle name | |
Last name | Kazuo YAMAMOTO |
ORTHOMEDICO, Inc.
R&D Department
2F Sumitomo Fudosan Korakuen Bldg., 1-4-1 Koishikawa, Bunkyo-ku, Tokyo.
03-3818-0610
kazu@orthomedico.jp
1st name | |
Middle name | |
Last name | Naoko SUZUKI |
ORTHOMEDICO, Inc.
R&D Department
2F Sumitomo Fudosan Korakuen Bldg., 1-4-1 Koishikawa, Bunkyo-ku, Tokyo.
03-3818-0610
nao@orthomedico.jp
ORTHOMEDICO, Inc.
Fukuyama Kurozu Inc..
Profit organization
Seishin-kai Medical Association Inc, Takara Medical Clinic.
NO
医療法人社団 盛心会 タカラクリニック (東京都)
Seishin-kai Medical Association Inc, Takara Medical Clinic (Tokyo)
2016 | Year | 09 | Month | 01 | Day |
Unpublished
Completed
2016 | Year | 08 | Month | 29 | Day |
2016 | Year | 09 | Month | 02 | Day |
2016 | Year | 09 | Month | 01 | Day |
2017 | Year | 05 | Month | 02 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027521
Research Plan | |
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Research case data specifications | |
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Research case data | |
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