UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A study to evaluate the effect of improving blood pressure and obesity by ingestion of botanical ingredient-containing foods.
Title of the study (Brief title)	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	Katsuyoshi Oishi
Organization	OCHAMURA,Inc.
Division name	Business management department
Address	1069, Murooka, Yame-shi, Fukuoka
TEL	0943-24-0001
Email	katsuyoshi@ochamura.jp

Public contact
Name of contact person	Shingo Yamamichi
Organization	TTC Co.,Ltd
Division name	Clinical Research Planning Department
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2017 Year 03 Month 23 Day
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

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Publication of results	Unpublished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