Unique ID issued by UMIN | UMIN000030110 |
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Receipt number | R000034379 |
Scientific Title | The verification study of triglyceride level in blood suppression effects: a randomized, double-blind, parallel-group, placebo-controlled trial |
Date of disclosure of the study information | 2017/11/24 |
Last modified on | 2018/04/24 16:53:55 |
The verification study of triglyceride level in blood suppression effects: a randomized, double-blind, parallel-group, placebo-controlled trial
The verification study of triglyceride level in blood suppression effects
The verification study of triglyceride level in blood suppression effects: a randomized, double-blind, parallel-group, placebo-controlled trial
The verification study of triglyceride level in blood suppression effects
Japan |
Healthy Japanese adult people
Not applicable | Adult |
Others
NO
To verify triglyceride level in blood suppression effects by ingestion of the test food for 8 weeks.
Safety,Efficacy
Confirmatory
Pragmatic
Not applicable
Triglyceride
* Assess at screening and examination before consuming and at 4 and 8 weeks after consuming
1. Total cholesterol
2. High-density lipoprotein (HDL) cholesterol
3. Low-density lipoprotein (LDL) cholesterol
* Assess at screening and examination before consuming and at 4 and 8 weeks after consuming
Interventional
Parallel
Randomized
Individual
Double blind -all involved are blinded
Active
NO
NO
Institution is not considered as adjustment factor.
NO
No need to know
2
Treatment
Food |
Duration: 8 weeks
Active: Pure white sesame oil
Administration: Eat 14 g/day of the active oil with the bread from the store or eat the oil directly at breakfast.
* If you forget to eat the active oil, take it at lunch or dinner.
* If you eat the active oil with a different way, record the diary designated by the contract research organization.
Duration: 8 weeks
Placebo: Blended oil (soybean oil and rape seed oil)
Administration: Eat 14 g/day of the placebo oil with bread from the store or eat the oil directly at breakfast.
* If you forget to eat the placebo oil, take it at lunch or dinner.
* If you eat the placebo oil with a different way, record the diary designated by the contract research organization.
20 | years-old | <= |
Not applicable |
Male and Female
1. Healthy Japanese adult people with relatively higher level of blood triglyceride
2. Subjects who are judged as eligible to participate in the study by the principal investigator
3. Among the subjects who met 2nd inclusion criteria, preferentially select subjects whose blood triglyceride level is on the borderline (120 ~ 149 mg/dL), then select subjects whose blood triglyceride level is relatively higher (150 ~ 199 mg/dL).
If the number of people who met 2nd inclusion criteria is less than the sample size, select subjects whose blood triglyceride level is relatively higher, however, less than 120 mg/dL.
1. At least one previous medical history or under the treatment 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. Subjects who use or take "Foods for Specified Health Uses", "Foods with Functional Claims", or other functional foods/beverages in daily
4. Currently taking medicines (include herbal medicines) and supplements
5. Subjects who are allergic to medicines and/or the test food related products
*Particularly, sesame and soybean allergies
6. Subjects who are pregnant, breast-feeding, and planning to become pregnant
7. Subjects who have been enrolled in other clinical trials within the last three months before the agreement to participate in this trial
8. Subjects who are judged as ineligible to participate in the study by the principal investigator
20
1st name | |
Middle name | |
Last name | Kazuo YAMAMOTO |
ORTHOMEDICO Inc.
CEO
2F Sumitomo Fudosan Korakuen Bldg., 1-4-1, Koishikawa, Bunkyo-ku, Tokyo, Japan.
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, Japan.
03-3818-0610
nao@orthomedico.jp
ORTHOMEDICO Inc.
Kadoya Sesame Mills Incorporated
Profit organization
Medical Corporation Seishinkai, Takara Clinic
NO
医療法人社団盛心会 タカラクリニック (東京都)
Medical Corporation Seishinkai, Takara Clinic (Tokyo, Japan)
2017 | Year | 11 | Month | 24 | Day |
Unpublished
Completed
2017 | Year | 11 | Month | 21 | Day |
2017 | Year | 11 | Month | 25 | Day |
2017 | Year | 11 | Month | 24 | Day |
2018 | Year | 04 | Month | 24 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034379
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