UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000026839
Receipt number 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 17:02:57

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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 or person

Institute

TTC Co.,Ltd

Institute

Department

Personal name



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

Value
https://center6.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