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
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
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
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
