Unique ID issued by UMIN | UMIN000016509 |
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Receipt number | R000019173 |
Scientific Title | Effect of postprandial blood glucose level by the continuity intake of salmon milt peptides in placebo-controlled double blind cross over clinical trial |
Date of disclosure of the study information | 2015/02/11 |
Last modified on | 2015/08/24 15:54:08 |
Effect of postprandial blood glucose level by the continuity intake of salmon milt peptides in placebo-controlled double blind cross over clinical trial
Effect of salmon milt peptides on postprandial blood glucose level
Effect of postprandial blood glucose level by the continuity intake of salmon milt peptides in placebo-controlled double blind cross over clinical trial
Effect of salmon milt peptides on postprandial blood glucose level
Japan |
postprandial hyperglycemia
Endocrinology and Metabolism |
Others
NO
The purpose is to evaluate the effect of salmon milt peptides on the postprandial blood glucose level by double-blind, placebo-controlled cross over test.
Efficacy
Confirmatory
Pragmatic
Phase III
Serum glucose level
Insulin
Interventional
Cross-over
Randomized
Individual
Double blind -all involved are blinded
Placebo
YES
NO
Institution is not considered as adjustment factor.
YES
Central registration
2
Treatment
Food |
Intake 500 mg salmon milt peptides capsule for 1 week, and take wash out period for 1 week, and then, intake placebo capsule for 1 week.
Intake placebo capsule for 1 week, and take wash out period for 1 week, and then, intake 500mg salmon milt peptides capsule for 1 week.
35 | years-old | <= |
65 | years-old | > |
Male and Female
(1)Subjects with high serum glucose levels at 60 min after oral glucose load.
(2)Subjects who agree to participate in the current study with written informed consent.
(1) Subjects who are under medication for diabetes and dyslipidemia.
(2) HbA1c>=6.6%
(3) FPG>=126mg/dl
(4) Subjects with insulin resistance (HOMA-IR>=2.5)
(5) Subjects with serious disease and infection
(6) Subjects with clinical history of gastrointestinal surgery.
(7) Subjects with unusually high and/or low blood pressure, or with abnormal hematological data.
(8) Subjects with serious anemia.
(9) Subjects with frequent complaints of post-menopausal symptoms.
(10)Subjects with a history of allergy to medicine and food, especially salmon and gelatin.
(11) Subjects routinely on supplementation which would affect glucose metabolism.
(12) Subjects routinely on supplementation which would affect lipid metabolism.
(13) Heavy smokers and alcohol addicts, or subjects with irregular lifestyle.
(14) Subjects who donate 400ml whole blood within 12 weeks or who donate plasma or platelets within 4 weeks prior to supplementation.
(15) Subjects who are pregnant or under lactation, or ones who would be expected to be pregnant during the study.
(16) Subjects who participate in other clinical trials within the last one month prior to the current clinical trial.
(17) Subjects who are not eligible due to physician's judgment.
12
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, 069-8585, Hokkaido
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, 069-8585, Hokkaido
011-385-4430
nishihira@do-johodai.ac.jp
Hokkaido Information University
Maruha Nichiro Corporation
Profit organization
Japan
NO
北海道情報大学 保健センター(北海道)
2015 | Year | 02 | Month | 11 | Day |
Unpublished
Completed
2015 | Year | 01 | Month | 30 | Day |
2015 | Year | 02 | Month | 24 | Day |
2015 | Year | 03 | Month | 31 | Day |
2015 | Year | 04 | Month | 15 | Day |
2015 | Year | 04 | Month | 22 | Day |
2015 | Year | 06 | Month | 30 | Day |
2015 | Year | 02 | Month | 11 | Day |
2015 | Year | 08 | Month | 24 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019173
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