Unique ID issued by UMIN | UMIN000028785 |
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Receipt number | R000032943 |
Scientific Title | Effect of Daily Ingestion of Lyophilized Powder of Solanum melongena on Blood Pressure for 8 weeks: A Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Dose-Finding Study |
Date of disclosure of the study information | 2017/08/23 |
Last modified on | 2018/07/09 09:37:44 |
Effect of Daily Ingestion of Lyophilized Powder of Solanum melongena on Blood Pressure for 8 weeks: A Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Dose-Finding Study
Beneficial Effects of Lyophilized Powder of Solanum melongena on blood pressure
Effect of Daily Ingestion of Lyophilized Powder of Solanum melongena on Blood Pressure for 8 weeks: A Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Dose-Finding Study
Beneficial Effects of Lyophilized Powder of Solanum melongena on blood pressure
Japan |
Healthy adults
Adult |
Others
NO
To prove clinical benefits associated with 8 week daily ingestion of lyophilized powder of Solanum melongena on blood pressure. Additionally to examine anti-stress effects etc. in order to evaluate the comprehensive effects of lyophilized powder of Solanum melongena for health promotion and health maintenance.
Safety,Efficacy
Pragmatic
Hospital blood pressure at 4 and 8 weeks after beginning the ingestion of test food.
Home blood pressure (morning and evening), salivary chromogranin A, salivary cortisol, salivary sIgA, VAS questionnaire assessed stress etc., POMS 2 full-length versions for adults, Pittsburgh Sleep Quality Index, Food Frequency Questionnaires
Interventional
Parallel
Randomized
Individual
Double blind -all involved are blinded
Placebo
YES
NO
YES
No need to know
4
Treatment
Food |
Daily ingestion of capsules contained high-volume of lyophilized powder of Solanum melongena for 8 weeks.
Daily ingestion of capsules contained medium-volume of lyophilized powder of Solanum melongena for 8 weeks.
Daily ingestion of capsules contained low-volume of lyophilized powder of Solanum melongena for 8 weeks.
Daily ingestion of placebo-capsules for 8 weeks.
35 | years-old | <= |
65 | years-old | > |
Male and Female
1.Subjects with normal-high blood pressure/grade1 hypertension.
2.Subjects who are feeling stress.
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 hypertension, schizophrenia, depressive disorder, mania and/or neurologic disorder.
2.Subjects whose BMI is >=30 kg/m2.
3.Subjects who have (or suspected) secondary hypertension such as renovascular hypertension, renal parenchymal hypertension, primary aldosteronism, Cushing's syndrome, hypothyroidism, hyperthyroidism, etc.
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 the 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 of obvious physical changes.
9.Subjects who are at risk of having allergic reactions to drugs or foods especially based on Solanum melongena.
10.Subjects who regularly take medicine, functional foods, and/or supplements which would affect blood pressure and/or stress.
11.Heavy smokers, alcohol addicts or subjects with disordered lifestyle.
12.Subjects who donated either 400 ml whole blood within 16 weeks (women), 12 weeks (men), 200 ml whole blood within 4 weeks (men and women), or blood components within 2 weeks (men and women), prior to the current study.
13.Pregnant or lactating women or women who 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 in the current study, as judged by the principal investigator.
52
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 Research Center
59-2, Nishi-nopporo, Ebetsu, Hokkaido, 069-8585, Japan
011-385-4430
nishihira@do-johodai.ac.jp
Hokkaido Information University
NARO Bio-oriented Technology Research Advancement Institution
Government offices of other countries
Japan
1.Department of Bioscience and Biotechnology, Faculty of Agriculture, Shinshu University
2. ADEKA corporation
3. Wellnas.Co.,Ltd.
NO
北海道情報大学 保健センター(北海道)
2017 | Year | 08 | Month | 23 | Day |
Unpublished
Completed
2017 | Year | 06 | Month | 22 | Day |
2017 | Year | 08 | Month | 25 | Day |
2017 | Year | 11 | Month | 27 | Day |
2018 | Year | 01 | Month | 24 | Day |
2018 | Year | 01 | Month | 29 | Day |
2018 | Year | 05 | Month | 25 | Day |
This study will be conducted by "Development of Foods with Function Claims for adding higher value to eggplant using new functional ingredients" (Project Number 16932813) in the special scheme project on vitalizing management entities of agriculture, forestry and fisheries from NARO.
2017 | Year | 08 | Month | 23 | Day |
2018 | Year | 07 | Month | 09 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032943
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