Unique ID issued by UMIN | UMIN000028600 |
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Receipt number | R000032736 |
Scientific Title | Evaluation of the effect of lactic acid bacteria on glucose metabolism in subjects with borderline diabetes |
Date of disclosure of the study information | 2017/08/10 |
Last modified on | 2019/01/24 10:16:25 |
Evaluation of the effect of lactic acid bacteria on glucose metabolism in subjects with borderline diabetes
Evaluation of the effect of lactic acid bacteria on glucose metabolism in subjects with borderline diabetes
Evaluation of the effect of lactic acid bacteria on glucose metabolism in subjects with borderline diabetes
Evaluation of the effect of lactic acid bacteria on glucose metabolism in subjects with borderline diabetes
Japan |
Healthy volunteers
Adult |
Others
NO
To investigate the effect of Pediococcus pentosaceus LP28 on impaired glucose tolerance.
Efficacy
Exploratory
Pragmatic
Not applicable
12-week change in OGTT-2h
12-week changes in AUC, Cmax and Tmax of blood glucose and insulin in OGTT, insulinogenic index, FBS, HOMA-R, HbA1c, glycoalbumin, visceral fat area, body fat percentage, abdominal circumference
Interventional
Parallel
Randomized
Individual
Double blind -all involved are blinded
Placebo
NO
NO
YES
Central registration
2
Prevention
Food |
Intake of granulated powder containing Pediococcus pentosaceus LP28 and dextrin (2 g/day) for 12 weeks.
Intake of granulated powder of dextrin (2 g/day) for 12 weeks.
20 | years-old | <= |
70 | years-old | >= |
Male and Female
140<= OGTT-2h <200 mg/dL
1) HbA1c>=6.5%
2) Taking medicines or receiving health guidance for hypertension, diabetes, and/or hyperlipidemia
3) Taking drugs or functional food that may affect the trial
4) Participation in any clinical trial within 90 days of the commencement of the trial
5) In pregnancy or nursing a child
6) Judged as ineligible by clinical investigators
40
1st name | |
Middle name | |
Last name | Fumiko Higashikawa |
Hiroshima University, Institute of Biomedical & Health Sciences
Project Research Center for Clinical Trial and Preventive Medicine
Kasumi 1-2-3, Minami-ku, Hiroshima 734-8551, JAPAN
082-257-1533
fumiko@hiroshima-u.ac.jp
1st name | |
Middle name | |
Last name | Fumiko Higashikawa |
Hiroshima University, Institute of Biomedical & Health Sciences
Project Research Center for Clinical Trial and Preventive Medicine
Kasumi 1-2-3, Minami-ku, Hiroshima 734-8551, JAPAN
082-257-1533
fumiko@hiroshima-u.ac.jp
Hiroshima University
Ministry of Education, Culture, Sports, Science and Technology
Japanese Governmental office
NO
広島大学病院(広島県)
2017 | Year | 08 | Month | 10 | Day |
Unpublished
Completed
2017 | Year | 08 | Month | 02 | Day |
2017 | Year | 10 | Month | 01 | Day |
2017 | Year | 08 | Month | 09 | Day |
2019 | Year | 01 | Month | 24 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032736
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