Unique ID issued by UMIN | UMIN000026254 |
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Receipt number | R000030155 |
Scientific Title | A Double-Blind, Placebo-Controlled Study for Effects of Daily Oral Administration of "Dattan Soba Seikatsu" on Blood pressure and Blood flow improvement. |
Date of disclosure of the study information | 2017/02/23 |
Last modified on | 2018/10/24 15:09:49 |
A Double-Blind, Placebo-Controlled Study for Effects of Daily Oral Administration of "Dattan Soba Seikatsu" on Blood pressure and Blood flow improvement.
Effect of Daily Oral Administration of "Dattan Soba Seikatsu" on Blood pressure and blood flow.
A Double-Blind, Placebo-Controlled Study for Effects of Daily Oral Administration of "Dattan Soba Seikatsu" on Blood pressure and Blood flow improvement.
Effect of Daily Oral Administration of "Dattan Soba Seikatsu" on Blood pressure and blood flow.
Japan |
Healthy adults
Adult |
Others
NO
The purpose is to evaluate the effect of 12 weeks ingestion of Dattan Soba Seikatsu on the blood pressure and blood flow.
Efficacy
Pragmatic
Not applicable
Systolic and diastolic blood pressure at 4weeks, 8 weeks and 12 weeks after the beginning of daily ingestion of test meals.
Home blood pressure (SBP and DBP) during the test period.
Peripheral blood flow at 4weeks, 8 weeks and 12 weeks after the beginning of daily ingestion of test meals.
Blood lipid (TC, LDL-Cho, HDL-Cho, TG, Arteriosclerotic index), Blood glucose (fasting blood glucose, HbA1c), Adiponectin, Oxidative lipid marker (oxo-LDL, TBARS), Body composition (BW, BFP, BMI).
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 Dattan Soba Seikatsu for 12 weeks.
Ingestion of placebo capsule for 12 weeks.
40 | years-old | <= |
75 | years-old | > |
Male and Female
1. Subjects satisfy the conditions of a and/or b.
a. SBP is >=130mmHg and < 160mmHg and/or DBP is >=85 mmHg and < 100mmHg.
b. Home SBP is >=125mmHg and < 155mmHg and/or DBP is >=80 mmHg and < 95mmHg.
2. Subjects who agree to participate in the current study with written informed consent.
1. Subjects who are under treatment and medication for diabetes and dyslipidemia.
2. Subjects with serious disease and infection.
3. Subjects with clinical history of gastrointestinal surgery.
4. Subjects with unusually high and/or low blood pressure, or with abnormal hematological data.
5. Subjects with serious anemia.
6. Subjects with frequent complaints of post-menopausal symptoms.
7. Subjects with a history of allergy to medicine and food, especially buckwheat and/or gelatin.
8. Subjects regularly take medicine, functional foods and/or supplements which would affect blood pressure and blood flow.
9. Subjects can not stop an intake of medicine, functional foods, supplements, buckwheat and Tartary buckwheat.
10. Subjects who are heavy smokers and alcohol addicts, or subjects with irregular lifestyle.
11. Subjects who donated either 400 ml whole blood within 12 weeks (men) /16 weeks (women) or 200 ml whole blood within 4 weeks or blood components within 2 weeks prior to this study.
12. Subjects who are pregnant or under lactation, or ones who would be expected to be pregnant during the study.
13. Subjects who participate in other clinical trials within the last 4 weeks prior to the current clinical trial.
14. Subjects who are not eligible due to physician's judgment.
46
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
AMC Consulting, Inc
Profit organization
NO
北海道情報大学 保健センター(北海道)
Hokkaido Information University Health center.
2017 | Year | 02 | Month | 23 | Day |
Published
Completed
2016 | Year | 10 | Month | 28 | Day |
2017 | Year | 01 | Month | 18 | Day |
2017 | Year | 05 | Month | 17 | Day |
2017 | Year | 07 | Month | 04 | Day |
2017 | Year | 07 | Month | 05 | Day |
2017 | Year | 12 | Month | 31 | Day |
2017 | Year | 02 | Month | 21 | Day |
2018 | Year | 10 | Month | 24 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030155
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