Unique ID issued by UMIN | UMIN000019474 |
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Receipt number | R000022313 |
Scientific Title | A randomized, double-blind, placebo-controlled, parallel-group, multi-center clinical trial to assess the effect of Bifidobacterium longum BB536 ingestion on improvement of blood hemoglobin. |
Date of disclosure of the study information | 2015/10/24 |
Last modified on | 2018/06/14 19:20:34 |
A randomized, double-blind, placebo-controlled, parallel-group, multi-center clinical trial to assess the effect of Bifidobacterium longum BB536 ingestion on improvement of blood hemoglobin.
A clinical trial to assess the effect of Bifidobacterium longum BB536 ingestion on hemoglobin improvement.
A randomized, double-blind, placebo-controlled, parallel-group, multi-center clinical trial to assess the effect of Bifidobacterium longum BB536 ingestion on improvement of blood hemoglobin.
A clinical trial to assess the effect of Bifidobacterium longum BB536 ingestion on hemoglobin improvement.
Japan |
None(Healthy subjects)
Not applicable | Adult |
Others
NO
This study aimed to evaluate the efficacy of Bifidobacterium longum BB536 ingestion in improvement of hemoglobin value in women.
Efficacy
Anemia-related indcator(12 weeks after intake)
Interventional
Parallel
Randomized
Individual
Double blind -all involved are blinded
Placebo
YES
NO
Institution is considered as a block.
YES
2
Treatment
Food |
Daily ingestion of 2 capsules containing Bifidobacterium longum BB536 for 12 weeks.
Daily ingestion of 2 placebo capsules devoid of Bifidobacterium longum BB536 for 12 weeks.
18 | years-old | <= |
Not applicable |
Female
(1) Women who are more than 18 years old at the time of informed consent acquisition
(2) Subjects whose Hb levels are above 12 g/dL and less than 13 g/dL.
(1)Subjects who regularly uses the health foods such as supplements for the purpose of iron or folic acid supply.
(2)Subjects who have serious disease
(liver, kidney, cerebrovascular, endocrine metabolic diseases, infectious diseases that requires notification) needed to notify
(3)Subjects receiving treatment or medication for cancer, and subjects with a history of cancer.
(4)Subjects who have a history of major surgery of digestive system
(5)Subject with irritable bowel syndrome, inflammatory bowel syndrome or gastrointestinal dysfunction
(6)Subject who regularly undertakes
medication or treatment that affects bowel motion (such as: antibiotics, antiflatulents, laxatives, antidiarrheal drug) or functional food / nutraceuticals, health supplements (such as: lactic acid bacteria, bifidobacteria, oligosaccharides, dietary fiber)
(7)Subject with a history of allergy to medicine and food
(8)Subject 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
(9)Subject who is judged to be ineligible due to subject's background, physical findings, medical examination, physical and clinical examination by principal investigator or sub investigator.
60
1st name | |
Middle name | |
Last name | Taeko Shimoda |
Nara Women's University
Department of Food and Nutrition
Kita-Uoya Nishimachi, Nara 630-8506 Japan
0742203893
t-shimoda@cc.nara-wu.ac.jp
1st name | |
Middle name | |
Last name | Taeko Shimoda |
Nara Women's University
Department of Food and Nutrition
Kita-Uoya Nishimachi, Nara 630-8506 Japan
0742-20-3893
t-shimoda@cc.nara-wu.ac.jp
Tenshi College
Morinaga Milk Industry Co., Ltd.
Profit organization
Japan
NO
天使大学(北海道)、東京医療保健大学(東京都)/Tenshi College, Tokyo Healthcare University
2015 | Year | 10 | Month | 24 | Day |
Unpublished
Completed
2015 | Year | 09 | Month | 10 | Day |
2015 | Year | 10 | Month | 24 | Day |
2015 | Year | 10 | Month | 23 | Day |
2018 | Year | 06 | Month | 14 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022313
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