Unique ID issued by UMIN | UMIN000014426 |
---|---|
Receipt number | R000016789 |
Scientific Title | A randomized, double-blind, placebo-controlled, parallel-group clinical trial to study the effect of continuous ingestion of Bifidobacterium breve strain B-3 on body fat reduction. |
Date of disclosure of the study information | 2014/06/30 |
Last modified on | 2015/04/21 11:05:53 |
A randomized, double-blind, placebo-controlled, parallel-group clinical trial to study the effect of continuous ingestion of Bifidobacterium breve strain B-3 on body fat reduction.
A clinical trial to study the effect of continuous ingestion of Bifidobacterium B-3 on body fat reduction.
A randomized, double-blind, placebo-controlled, parallel-group clinical trial to study the effect of continuous ingestion of Bifidobacterium breve strain B-3 on body fat reduction.
A clinical trial to study the effect of continuous ingestion of Bifidobacterium B-3 on body fat reduction.
Japan |
Obese
Endocrinology and Metabolism |
Others
NO
The aim of this study is to evaluate the efficacy of continuous ingestion of Bifidobacterium B-3 in the abatement of body fat, body weight and visceral fat by a placebo-controlled double-blind, randomized clinical trial.
Efficacy
Confirmatory
Pragmatic
Phase III
Body composition (body weight, body fat percentage, BMI), abdominal visceral fat area
Lipids metabolism parameters(T-Cho,HDL-Cho,LDL-Cho,TG,NEFA), blood glucose metabolism parameters (FBG, HbA1c, insulin), abdominal circumference, enteric environment (enterobacterial flora analysis, defecation frequency), inflammatory marker (hs-CRP), liver function (AST, ALT, gamma-GTP, ALP, LDH), total protein, albumin, cytokine (adiponectin, IL-6)
Interventional
Parallel
Randomized
Individual
Double blind -all involved are blinded
Placebo
YES
NO
Institution is not considered as adjustment factor.
YES
Central registration
2
Treatment
Food |
Daily ingestion of 2 capsules containing Bifidobacterium B-3 for 12 weeks.
Daily ingestion of 2 placebo capsules devoid of Bifidobacterium B-3 for 12 weeks.
40 | years-old | <= |
65 | years-old | > |
Male and Female
1.Subjects who have BMI ranging from 23 to 30
2.Subjects who give written informed consent prior to the study.
1.Subjects who have serious disease (cerebrovascular, heart, liver, kidney, gastrointestinal, endocrine metabolic diseases, infectious diseases that requires notification)
2.Subjects with a history of gastro
-intestinal related cancer or those who undertake medication or treatment for such disease
3.Subjects having a history of major surgery involving gastrectomy, gastrointestinal suture surgery, bowel resection, digestive system etc.
4.Subjects with irritable bowel
syndrome, inflammatory bowel syndrome or gastrointestinal dysfunction
5.Subjects who is under medication or treatment for diabetes, dyslipidemia, high blood pressure
6.Subjects who regularly undertakes medication, treatment, functional food, nutraceuticals, or health supplements that affects bowel motion
7.Subjects who regularly take drugs, functional food, nutraceuticals or health supplements that affect serum lipids
8.Subjects who has defecation frequency less than thrice per week, or frequent symptoms of diarrhea
9.Subjects with frequent complaints of
post-menopausal symptoms
10.Subjects with unusually high and/or low blood pressure, or with abnormal hematological data
11. Subjects with serious anemia
12. Subjects with a history of allergy to medicine and food
13. Heavy smoker and alcohol addict, or subjects with irregular lifestyle
14.Subjects who donated 400ml whole blood within past 12 weeks or 200ml whole blood within past 4 weeks or plasma or platelets within past 2 weeks prior to this study
15.Subjects who is pregnant or under lactation, or who is expected to be pregnant during the study
16.Subjects who is currently participating in or who had participated in other clinical trials within the last one month prior to this study
17.Subjects who are judged ineligible by our physician.
90
1st name | |
Middle name | |
Last name | Prof. Jun Nishihira, M.D. |
Hokkaido Information University
Department of Medical Management and Informatics
59-2, Nishi Nopporo, Ebetsu, Hokkaido, 069-8585, Japan
011-385-4411
nishihira@do-johodai.ac.jp
1st name | |
Middle name | |
Last name | Dir. Prof. Jun Nishihira, M.D. |
Hokkaido Information University
Health Information Science Center
59-2, Nishi Nopporo, Ebetsu, Hokkaido, 069-8585, Japan
011-385-4430
nishihira@do-johodai.ac.jp
Hokkaido Information University
Morinaga Milk Industry Co., Ltd.
Profit organization
NO
北海道情報大学 保健センター(北海道)
2014 | Year | 06 | Month | 30 | Day |
Unpublished
Completed
2014 | Year | 06 | Month | 20 | Day |
2014 | Year | 07 | Month | 25 | Day |
2014 | Year | 12 | Month | 07 | Day |
2015 | Year | 01 | Month | 08 | Day |
2015 | Year | 01 | Month | 15 | Day |
2015 | Year | 03 | Month | 26 | Day |
2014 | Year | 06 | Month | 30 | Day |
2015 | Year | 04 | Month | 21 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016789
Research Plan | |
---|---|
Registered date | File name |
Research case data specifications | |
---|---|
Registered date | File name |
Research case data | |
---|---|
Registered date | File name |