Unique ID issued by UMIN | UMIN000010813 |
---|---|
Receipt number | R000012600 |
Scientific Title | A randamized, double-blind, placebo-controlled, parallel group study to evaluate the efficacy and safety of oral administration of probiotic LKM512 in individuals with pre-arteriosclerosis |
Date of disclosure of the study information | 2013/05/27 |
Last modified on | 2015/11/27 15:27:40 |
A randamized, double-blind, placebo-controlled, parallel group study to evaluate the efficacy and safety of oral administration of probiotic LKM512 in individuals with pre-arteriosclerosis
Effects of probiotics LKM512 in individuals with pre-arteriosclerosis: double-blind, placebo-controlled parallel group study
A randamized, double-blind, placebo-controlled, parallel group study to evaluate the efficacy and safety of oral administration of probiotic LKM512 in individuals with pre-arteriosclerosis
Effects of probiotics LKM512 in individuals with pre-arteriosclerosis: double-blind, placebo-controlled parallel group study
Japan |
Patients with high levels of serum triglyceride
Medicine in general |
Others
NO
To evaluate the efficacy of oral administration of bifidobacteria LKM512 on inflammation-related markers in patients with high levels of serum triglyceride
Efficacy
Exploratory
Inflammation-related markers (CoQ10, adiponectine, ICAM-a, TNF-alpha, s-LOX, LAB)
Interventional
Parallel
Randomized
Individual
Double blind -all involved are blinded
Placebo
2
Treatment
Food |
The volunteer were given an 12-week treatment with oral administration of bifidobacteria LKM512 powder (10 billion bacterial cells/package) two times per day.
The volunteer were given an 12-week treatment with oral administration of placebo powder without bifidobacteria LKM512 two times per day.
20 | years-old | <= |
65 | years-old | > |
Male and Female
Outpatients whose serum triglyceride level is 100 to 250 mg/dL
(1)Subjects who are undergoing dyslipidemia treatment
(2)Subjects who take medicine that influencea value of cholesterol
(3)Seriouse subjects who have complications with cardiac disease, hepatic disease, and/or renal disease
(4)Subjects who was enrolled in other trails within three month.
(5)Inappropriate cases evaluated by doctors
30
1st name | |
Middle name | |
Last name | Mitsuharu Matsumoto |
Kyodo Milk Industry Co. Ltd.
Research Laboratories
20-1 Hirai, Hinode-machi, Nishitama-gun, Tokyo 190-0182
042-597-5911
m-matumoto@meito.co.jp
1st name | |
Middle name | |
Last name | Satoshi Sakurai |
Imeq CO. Ltd.
CRO division
4-17-15 Takadanobaba, Shinjuku-ku, Tokyo
03-6279-3591
s-sakurai@imeq.co.jp
Kyodo Milk Industry Co. Ltd.
Kyodo Milk Industry Co. Ltd.
Profit organization
NO
2013 | Year | 05 | Month | 27 | Day |
Unpublished
Open public recruiting
2013 | Year | 04 | Month | 22 | Day |
2013 | Year | 05 | Month | 30 | Day |
2013 | Year | 10 | Month | 10 | Day |
2013 | Year | 10 | Month | 30 | Day |
2013 | Year | 11 | Month | 06 | Day |
2013 | Year | 11 | Month | 06 | Day |
2013 | Year | 05 | Month | 27 | Day |
2015 | Year | 11 | Month | 27 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012600
Research Plan | |
---|---|
Registered date | File name |
Research case data specifications | |
---|---|
Registered date | File name |
Research case data | |
---|---|
Registered date | File name |