Unique ID issued by UMIN | UMIN000027709 |
---|---|
Receipt number | R000031741 |
Scientific Title | Study of the body fat-reducing effect of the 12-week intake of food containing lactic acid bacteria: A randomized, double-blind, placebo-controlled, parallel-group study |
Date of disclosure of the study information | 2017/06/12 |
Last modified on | 2018/06/01 10:46:11 |
Study of the body fat-reducing effect of the 12-week intake of food containing lactic acid bacteria: A randomized, double-blind, placebo-controlled, parallel-group study
Study of the body fat-reducing effect of the 12-week intake of food containing lactic acid bacteria
Study of the body fat-reducing effect of the 12-week intake of food containing lactic acid bacteria: A randomized, double-blind, placebo-controlled, parallel-group study
Study of the body fat-reducing effect of the 12-week intake of food containing lactic acid bacteria
Japan |
Overweight
Medicine in general | Endocrinology and Metabolism | Adult |
Others
NO
To examine the effect of reducing body fat by the intake of food containing lactic acid bacteria
Efficacy
Confirmatory
Explanatory
Phase II
Abdominal total fat area
Abdominal visceral fat area
Abdominal subcutaneous fat area
Body weight
Body mass index
Body fat percentage
Waist circumference, Hip circumference, Waist circumference/hip circumference
Blood fat level (triglyceride, total cholesterol, HDL cholesterol, LDL cholesterol)
Blood glucose level
HbA1c
Insulin
HOMA-IR
Blood ketone bodies level
Blood inflammatory cytokines
Blood adiponectin
Interventional
Parallel
Randomized
Individual
Double blind -all involved are blinded
Placebo
YES
NO
Institution is not considered as adjustment factor.
YES
Central registration
2
Prevention
Food |
12-week intake of the test food
12-week intake of the placebo food
20 | years-old | <= |
65 | years-old | > |
Male and Female
1)Healthy men and women of 20 to 64 years age
2)Subjects whose body mass indexes were 25 to 30 at the screening period
3)Subjects giving written informed consent
1)Subjects with severe onset of obesity-related disease (impaired glucose tolerance, dyslipidemia, hypertension, hyperuricemia, coronary artery disease, cerebral infarction, fatty liver, menstrual disorder and pregnancy complications, sleep apnea syndrome or obesity hypoventilation syndrome, orthopedic surgery, obesity-related kidney disease)
2)Subjects with food allergy or lactose intolerance
3)Subjects with a habit of intake more than twice in a week of fermented milk or lactic fermenting beverage in three months before screening test
4)Subjects with a habit of oral medication, supplements, health food affecting obesity, hyperlipidemia, glucese or lipid matabolism in three months before screening test, and subjects who will take these in the test period.
5)Subjects who are regularly practicing intense exercise (exercising for the purpose of muscle strengthening, attending exercise facilities more than three times in a week, etc.)
6)Subjects who have been drug dependency or alcohol dependency
7)Subjects who drink a lot of alcohol, and subjects who can not abstain from drinking from two days before the examination date
8)Subjects who have metal in the measurement site of CT scan
9)Subjects who contain cardiac pacemaker, implantable defibrillator
10)Subjects who have been diagnosed with familial hyperlipemia
11)Subjects in pregnancy or in nursing
12)Subjects whose eating habits are extremely irregulae (ex. midnight and irregulae shift worker)
13)Subjects who participated in other clinical trials within one month before the agreement of participants in this study
14)Subjects with claustrophobia
15)Subjects who are judged as unsuitable for the study by the investigator for other reasons
100
1st name | |
Middle name | |
Last name | Satoru Suzuki |
Shinagawa Season Terrace Health Care Clinic
Medical examination and treatment management family chief director
1-2-70, Konan, Minato-ku, Tokyo The 5th floor of Shinagawa season terrace
81-3-3452-3381
satoru_suzuki@sempos.or.jp
1st name | |
Middle name | |
Last name | Eiji Yoshikawa |
KSO Corporation
Sales department
1-9-7, Shibaura, Minato-ku, Tokyo The 7th floor of Shibaura omodaka buildin
81-3-3452-7733
yoshikawa@kso.co.jp
KSO Corporation
Food Microbiology Research Laboratories, Meiji Co., Ltd.
Profit organization
Japan
NO
2017 | Year | 06 | Month | 12 | Day |
Unpublished
Completed
2017 | Year | 06 | Month | 08 | Day |
2017 | Year | 08 | Month | 25 | Day |
2017 | Year | 12 | Month | 31 | Day |
2018 | Year | 01 | Month | 31 | Day |
2018 | Year | 02 | Month | 28 | Day |
2018 | Year | 03 | Month | 28 | Day |
2017 | Year | 06 | Month | 09 | Day |
2018 | Year | 06 | Month | 01 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031741
Research Plan | |
---|---|
Registered date | File name |
Research case data specifications | |
---|---|
Registered date | File name |
Research case data | |
---|---|
Registered date | File name |