UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000028785
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

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Basic information

Public 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

Acronym

Beneficial Effects of Lyophilized Powder of Solanum melongena on blood pressure

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

Scientific Title:Acronym

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 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.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2

Pragmatic

Developmental phase



Assessment

Primary outcomes

Hospital blood pressure at 4 and 8 weeks after beginning the ingestion of test food.

Key secondary outcomes

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


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

No need to know


Intervention

No. of arms

4

Purpose of intervention

Treatment

Type of intervention

Food

Interventions/Control_1

Daily ingestion of capsules contained high-volume of lyophilized powder of Solanum melongena for 8 weeks.

Interventions/Control_2

Daily ingestion of capsules contained medium-volume of lyophilized powder of Solanum melongena for 8 weeks.

Interventions/Control_3

Daily ingestion of capsules contained low-volume of lyophilized powder of Solanum melongena for 8 weeks.

Interventions/Control_4

Daily ingestion of placebo-capsules for 8 weeks.

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 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.

Target sample size

52


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Prof. Jun NISHIHIRA, M.D., Ph.D.

Organization

Hokkaido Information University

Division name

Department of Medical Management and Informatics

Zip code


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

1st name
Middle name
Last name Dir. Prof. Jun NISHIHIRA, M.D., Ph.D.

Organization

Hokkaido Information University

Division name

Health Information Science Research Center

Zip code


Address

59-2, Nishi-nopporo, Ebetsu, Hokkaido, 069-8585, Japan

TEL

011-385-4430

Homepage URL


Email

nishihira@do-johodai.ac.jp


Sponsor or person

Institute

Hokkaido Information University

Institute

Department

Personal name



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

Japan


Other related organizations

Co-sponsor

1.Department of Bioscience and Biotechnology, Faculty of Agriculture, Shinshu University
2. ADEKA corporation
3. Wellnas.Co.,Ltd.

Name of secondary funder(s)



IRB Contact (For public release)

Organization


Address


Tel


Email



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

2017 Year 08 Month 23 Day


Related information

URL releasing protocol


Publication of results

Unpublished


Result

URL related to results and publications


Number of participants that the trial has enrolled


Results


Results date posted


Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics


Participant flow


Adverse events


Outcome measures


Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Completed

Date of protocol fixation

2017 Year 06 Month 22 Day

Date of IRB


Anticipated trial start date

2017 Year 08 Month 25 Day

Last follow-up date

2017 Year 11 Month 27 Day

Date of closure to data entry

2018 Year 01 Month 24 Day

Date trial data considered complete

2018 Year 01 Month 29 Day

Date analysis concluded

2018 Year 05 Month 25 Day


Other

Other related information

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.


Management information

Registered date

2017 Year 08 Month 23 Day

Last modified on

2018 Year 07 Month 09 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032943


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name