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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000026839
Receipt No. R000030804
Scientific Title A study to evaluate the effect of improving blood pressure and obesity by ingestion of botanical ingredient-containing foods.
Date of disclosure of the study information 2018/09/03
Last modified on 2017/10/05

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Basic information
Public title A study to evaluate the effect of improving blood pressure and obesity by ingestion of botanical ingredient-containing foods.
Acronym A study to evaluate the effect of improving blood pressure and obesity by ingestion of botanical ingredient-containing foods.
Scientific Title A study to evaluate the effect of improving blood pressure and obesity by ingestion of botanical ingredient-containing foods.
Scientific Title:Acronym A study to evaluate the effect of improving blood pressure and obesity by ingestion of botanical ingredient-containing foods.
Region
Japan

Condition
Condition None
Classification by specialty
Not applicable Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the effect of improving blood pressure and obesity by ingestion of botanical ingredient-containing food.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Blood pressure, BMI, VFA and SFA
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Prevention
Type of intervention
Food
Interventions/Control_1 Ingestion of botanical ingredient-containing food for 12 weeks.
Interventions/Control_2
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
20 years-old <=
Age-upper limit
64 years-old >=
Gender Male and Female
Key inclusion criteria (1) Males and females aged 20 to less than 65 years old.
(2)Those who falling under any of the following criteria.
1. 130 mmHg<=SBP<160 mmHg and 85 mmHg<=DBP<100 mmHg
2. 23 kg/m2<=BMI<30 kg/m2
Key exclusion criteria (1) Subjects who eat botanical ingredient-containing food 3 times per week.
(2) Under losing body weight at advance examination.
(3) Use of product affecting the data of this study, such as medicine, food for specified health use, supplement, diet food.
(4) Subjects who are judged as unsuitable for the current study based on the results of lifestyle questionnaire
(5) With allergy to the study foods.
(6) Subjects having a disease requiring treatment or a history of serious diseases for which medication was required.
(7) Subjects who are judged as unsuitable for the study based on the results of clinical and physical examination.
(8) Subjects who are participated in other clinical studies.
(9) Females who are known or suspected to be pregnant, breastfeeding or desire to become pregnant during the trial period.
(10) Subjects who are judged unfit to enroll in this trial by the investigator.
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Katsuyoshi Oishi
Organization OCHAMURA,Inc.
Division name Business management department
Zip code
Address 1069, Murooka, Yame-shi, Fukuoka
TEL 0943-24-0001
Email katsuyoshi@ochamura.jp

Public contact
Name of contact person
1st name
Middle name
Last name Shingo Yamamichi
Organization TTC Co.,Ltd
Division name Clinical Research Planning Department
Zip code
Address Seibu Shinkin Bank Ebisu Bldg.,1-20-2, Ebisunishi, Shibuya-ku, Tokyo
TEL 03-5459-5329
Homepage URL
Email s.yamamichi@ttc-tokyo.co.jp

Sponsor
Institute TTC Co.,Ltd
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
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

Other administrative information
Date of disclosure of the study information
2018 Year 09 Month 03 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 03 Month 23 Day
Date of IRB
Anticipated trial start date
2017 Year 04 Month 09 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2017 Year 04 Month 03 Day
Last modified on
2017 Year 10 Month 05 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030804

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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