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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000033330
Receipt No. R000037995
Official scientific title of the study Effect of Daily Ingestion of Lyophilized Powder of Solanum melongena on Blood Pressure: A Randomized, Double-Blind, Placebo-Controlled, Parallel Group Comparison Study.
Date of disclosure of the study information 2018/07/10
Last modified on 2018/07/09

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Basic information
Official scientific title of the study Effect of Daily Ingestion of Lyophilized Powder of Solanum melongena on Blood Pressure: A Randomized, Double-Blind, Placebo-Controlled, Parallel Group Comparison Study.
Title of the study (Brief title) Beneficial Effects of Lyophilized Powder of Solanum melongena on Blood Pressure.
Region
Japan

Condition
Condition Healthy adults
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To prove clinical benefits associated with 12 week daily ingestion of lyophilized powder of Solanum melongena on blood pressure in a randomized, double-blind, placebo-controlled, parallel group comparison study.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2 Pragmatic
Developmental phase

Assessment
Primary outcomes Hospital blood pressure after 4, 8 and 12 weeks of ingestion and 4 weeks after the end of ingestion.
Key secondary outcomes Home blood pressure (morning and evening), pulse rate, VAS questionnaire assessed stress, POMS 2 full-length versions for adults, Food Frequency Questionnaires.

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Double blind -all involved are blinded
Control Placebo
Stratification YES
Dynamic allocation NO
Institution consideration
Blocking YES
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Food
Interventions/Control_1 Daily ingestion of capsules contained lyophilized powder of Solanum melongena for 12 weeks.
Interventions/Control_2 Daily ingestion of placebo-capsules for 12 weeks.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
35 years-old <=
Age-upper limit
65 years-old >
Gender Male and Female
Key inclusion criteria 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.
Key exclusion criteria 1.Subjects who are under physician's advice, treatment, and/or medication for hypertension, schizophrenia, depressive disorder, mania neurologic disorder, arrhythmia, and/or bradycardia.
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.
Target sample size 100

Research contact person
Name of lead principal investigator Prof. Jun NISHIHIRA, M.D., Ph.D.
Organization Hokkaido Information University
Division name Department of Medical Management and Informatics
Address 59-2, Nishi-nopporo, Ebetsu, Hokkaido, 069-8585, Japan
TEL 011-385-4411
Email nishihira@do-johodai.ac.jp

Public contact
Name of contact person Dir. Prof. Jun NISHIHIRA, M.D., Ph.D.
Organization Hokkaido Information University
Division name Health Information Science Research Center
Address 59-2, Nishi-nopporo, Ebetsu, Hokkaido, 069-8585, Japan
TEL 011-385-4430
Homepage URL
Email nishihira@do-johodai.ac.jp

Sponsor
Institute Hokkaido Information University
Institute
Department

Funding Source
Organization NARO Bio-oriented Technology Research Advancement Institution
Organization
Division
Category of Funding Organization Government offices of other countries
Nationality of Funding Organization

Other related organizations
Co-sponsor 1. Shinshu University
2. ADEKA corporation
3. Wellnas. Co., Ltd.
Name of secondary funder(s)

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions 北海道情報大学 保健センター(北海道)

Other administrative information
Date of disclosure of the study information
2018 Year 07 Month 10 Day

Progress
Recruitment status No longer recruiting
Date of protocol fixation
2018 Year 05 Month 25 Day
Anticipated trial start date
2018 Year 07 Month 10 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results Unpublished
URL releasing results
Results
Other related information

Management information
Registered date
2018 Year 07 Month 09 Day
Last modified on
2018 Year 07 Month 09 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037995

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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