Unique ID issued by UMIN | UMIN000026321 |
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Receipt number | R000030232 |
Scientific Title | A Randomized, Double-Blind, Placebo-Controlled, Parallel Group Comparison Study on Improvements in Glucose Metabolism by Daily Ingestion of Products Containing Pinitol |
Date of disclosure of the study information | 2017/02/27 |
Last modified on | 2019/02/28 14:36:50 |
A Randomized, Double-Blind, Placebo-Controlled, Parallel Group Comparison Study on Improvements in Glucose Metabolism by Daily Ingestion of Products Containing Pinitol
Improvements in Glucose Metabolism by Daily Ingestion of Products Containing Pinitol
A Randomized, Double-Blind, Placebo-Controlled, Parallel Group Comparison Study on Improvements in Glucose Metabolism by Daily Ingestion of Products Containing Pinitol
Improvements in Glucose Metabolism by Daily Ingestion of Products Containing Pinitol
Japan |
Healthy adults
Not applicable | Adult |
Others
NO
To investigate the safety and usefulness of 12-weeks daily ingestion of products containing pinitol for improvements in glucose metabolism.
Efficacy
Pragmatic
Not applicable
HbA1c levels after 4, 8 and 12 weeks of ingestion and 4weeks after the end of ingestion.
Fasting blood glucose, glycoalbumin, insulin and HOMA-IR
Interventional
Parallel
Randomized
Individual
Double blind -all involved are blinded
Placebo
YES
NO
Institution is not considered as adjustment factor.
YES
No need to know
2
Treatment
Food |
Ingestion of three capsules containing pinitol daily for 12 weeks.
Ingestion of three placebo capsules daily for 12 weeks.
20 | years-old | <= |
65 | years-old | > |
Male and Female
1. Subjects whose FBG is>=100mg/dl and <126mg/dl or HbA1c >=5.6% and <6.5%.
2. Subjects who have relatively high HOMA-IR levels (selected by the screening results).
3. Subjects who agree to participate in this study with a written informed consent.
1. Subjects who are under physician's advice, treatment and/or medication for diabetes.
2. Subjects whose HbA1c is >=6.5%
3. Subjects whose FBG is >=126 mg/dl.
4. Subjects with serious cerebrovascular, cardiac, hepatic, renal, gastrointestinal diseases, and/or affected with infectious diseases requiring reports to the authorities.
5. Subjects with major surgical history relevant to digestive system such as gastrectomy, gastrorrhaphy, enterectomy, etc.
6. Subjects with unusually high and/or low blood pressure and/or abnormal hematological data.
7. Subjects with severe anemia.
8. Pre- or post-menopausal women complaining obvious physical changes.
9. Subjects who are at risk of having allergic reactions to drugs or foods based on especially leguminous plants including soybeans, and ice plants, yeasts, gelatin and milk.
10. Subjects who regularly take medicine, functional foods and/or supplements (containing dietary fiber such as indigestible dextrin, polyphenol, etc.) which would affect glucose metabolism.
11. Heavy smokers, alcohol addicts or subjects with the eating disordered lifestyle.
12. Subjects who donated either 400ml whole blood within 16 weeks (women) /12 weeks (men) or 200ml whole blood within 4 weeks or blood components within 2 weeks prior to the current study.
13. Pregnant or lactating women or women expect to be pregnant during this study.
14. Subjects who currently participate in other clinical trials or participated within the last 4 weeks prior to the current study.
15. Any other medical and/ or health reasons unfavorable to participation into the current study judged by the principal investigator.
64
1st name | |
Middle name | |
Last name | Prof. Jun NISHIHIRA, M.D., Ph.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., Ph.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
The Ethics Committee approves that the source of funding shall not be disclosed.
Profit organization
Japan
NO
北海道情報大学 保健センター(北海道)
2017 | Year | 02 | Month | 27 | Day |
Unpublished
Completed
2016 | Year | 12 | Month | 21 | Day |
2017 | Year | 02 | Month | 28 | Day |
2017 | Year | 07 | Month | 16 | Day |
2017 | Year | 08 | Month | 30 | Day |
2017 | Year | 09 | Month | 06 | Day |
2017 | Year | 12 | Month | 20 | Day |
2017 | Year | 02 | Month | 27 | Day |
2019 | Year | 02 | Month | 28 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030232
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