Unique ID issued by UMIN | UMIN000028525 |
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Receipt number | R000032641 |
Scientific Title | Effects of functional foods on the blood cholesterol level -A randomized, double-blind, placebo-controlled, parallel-group comparative study- |
Date of disclosure of the study information | 2017/08/03 |
Last modified on | 2018/01/29 15:05:02 |
Effects of functional foods on the blood cholesterol level
-A randomized, double-blind, placebo-controlled, parallel-group comparative study-
Effects of functional foods on the blood cholesterol level
Effects of functional foods on the blood cholesterol level
-A randomized, double-blind, placebo-controlled, parallel-group comparative study-
Effects of functional foods on the blood cholesterol level
Japan |
hypercholesterolemia
Medicine in general | Cardiology |
Others
NO
To verify the effect of functional foods on the blood cholesterol.
Efficacy
blood LDL- cholesterol level
blood total- cholesterol level
blood non-HDL- cholesterol level
Interventional
Parallel
Randomized
Individual
Double blind -all involved are blinded
Placebo
No need to know
3
Treatment
Food |
Food1(Intake priod:12 weeks)
Food2(Intake priod:12 weeks)
Placebo(Intake priod:12 weeks)
20 | years-old | <= |
75 | years-old | > |
Male and Female
1)20 to 75 years at the time of informed consent and possible to visit.
2)Japanese males and females.
3)LDL-Cho >=140 mg/dl and <200 mg/dl.
1)Subjects who is taking the following medications within 3 months, or who is scheduled to take medication after informed consent to participate in this examination.
Fibrate-based medicine (bezafibrate etc), nicotinic acid, azole antifungal drug (itraconazole etc), macrolide antibiotics(erythromycin etc), coumarin-based anticoagulants(warfarin), antacid(magnesium hydroxide, aluminium hydroxide), lopinavir and ritonavir combination drug,Simeprevir, eltrombopag.
2)Subjects using steroidal and non-steroidal medicines (internal medicine / topical medicine).
3)Subjects who regularly use chemicals (orlistat (Xenical, Arai )etc) affecting fat absorption.
4)Subjects who previous or present serious disease such kidney, liver, circulatory system, benign neoplasm,mental, dementing disorder.
5)Subjects who are alcoholics or previous.
6)Subjects with hypothyroidism, patients with hereditary muscle disease (muscular dystrophy etc) or their family history, or those with a history of drug-induced myopathy.
7)Subjects who are receiving medication in diabetic patients or hypertensive patients.
8)Subjects who have allergy related to the study foods.
9)Subjects who using health foods (supplements, foods for specified health use, displayed functional foods), quasi-drugs, medicines that decrease LDL cholesterol.
10)Subjects who are participating within 3 months or planning to participate in other clinical study.
11)Subjects who are pregnant or breast-feeding.
12)Subjects who are judged as unsuitable for the study by the doctor and the investigator in charge for other reason.
75
1st name | |
Middle name | |
Last name | Tsuyoshi Yamato |
Medical Corporation Kouwakai Kouwa Clinic
Director
6-33-17, komagome, toshima-ku, Tokyo, Japan
03-3917-8105
info@kouwakai.jp
1st name | |
Middle name | |
Last name | Masao Matsuoka |
HUMA R&D CORP
Clinical Development Division
Oekkusu Bldg. 10th Fl., 5-31-19 Shiba,Minato-ku,108-0014,Japan
03-3431-1216
matsuoka@huma-c.co.jp
HUMA R&D CORP
FANCL Corporation
Profit organization
NO
2017 | Year | 08 | Month | 03 | Day |
Unpublished
Completed
2017 | Year | 07 | Month | 14 | Day |
2017 | Year | 08 | Month | 17 | Day |
2017 | Year | 08 | Month | 03 | Day |
2018 | Year | 01 | Month | 29 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032641
Research Plan | |
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