UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000026254
Receipt No. R000030155
Scientific Title A Double-Blind, Placebo-Controlled Study for Effects of Daily Oral Administration of "Dattan Soba Seikatsu" on Blood pressure and Blood flow improvement.
Date of disclosure of the study information 2017/02/23
Last modified on 2018/10/24

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title A Double-Blind, Placebo-Controlled Study for Effects of Daily Oral Administration of "Dattan Soba Seikatsu" on Blood pressure and Blood flow improvement.
Acronym Effect of Daily Oral Administration of "Dattan Soba Seikatsu" on Blood pressure and blood flow.
Scientific Title A Double-Blind, Placebo-Controlled Study for Effects of Daily Oral Administration of "Dattan Soba Seikatsu" on Blood pressure and Blood flow improvement.
Scientific Title:Acronym Effect of Daily Oral Administration of "Dattan Soba Seikatsu" on Blood pressure and blood flow.
Region
Japan

Condition
Condition Healthy adults
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The purpose is to evaluate the effect of 12 weeks ingestion of Dattan Soba Seikatsu on the blood pressure and blood flow.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Systolic and diastolic blood pressure at 4weeks, 8 weeks and 12 weeks after the beginning of daily ingestion of test meals.
Home blood pressure (SBP and DBP) during the test period.
Peripheral blood flow at 4weeks, 8 weeks and 12 weeks after the beginning of daily ingestion of test meals.
Key secondary outcomes Blood lipid (TC, LDL-Cho, HDL-Cho, TG, Arteriosclerotic index), Blood glucose (fasting blood glucose, HbA1c), Adiponectin, Oxidative lipid marker (oxo-LDL, TBARS), Body composition (BW, BFP, BMI).

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 Institution is not considered as adjustment factor.
Blocking YES
Concealment No need to know

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Food
Interventions/Control_1 Ingestion of Dattan Soba Seikatsu for 12 weeks.
Interventions/Control_2 Ingestion of placebo capsule for 12 weeks.
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
40 years-old <=
Age-upper limit
75 years-old >
Gender Male and Female
Key inclusion criteria 1. Subjects satisfy the conditions of a and/or b.
a. SBP is >=130mmHg and < 160mmHg and/or DBP is >=85 mmHg and < 100mmHg.
b. Home SBP is >=125mmHg and < 155mmHg and/or DBP is >=80 mmHg and < 95mmHg.
2. Subjects who agree to participate in the current study with written informed consent.
Key exclusion criteria 1. Subjects who are under treatment and medication for diabetes and dyslipidemia.
2. Subjects with serious disease and infection.
3. Subjects with clinical history of gastrointestinal surgery.
4. Subjects with unusually high and/or low blood pressure, or with abnormal hematological data.
5. Subjects with serious anemia.
6. Subjects with frequent complaints of post-menopausal symptoms.
7. Subjects with a history of allergy to medicine and food, especially buckwheat and/or gelatin.
8. Subjects regularly take medicine, functional foods and/or supplements which would affect blood pressure and blood flow.
9. Subjects can not stop an intake of medicine, functional foods, supplements, buckwheat and Tartary buckwheat.
10. Subjects who are heavy smokers and alcohol addicts, or subjects with irregular lifestyle.
11. Subjects who donated either 400 ml whole blood within 12 weeks (men) /16 weeks (women) or 200 ml whole blood within 4 weeks or blood components within 2 weeks prior to this study.
12. Subjects who are pregnant or under lactation, or ones who would be expected to be pregnant during the study.
13. Subjects who participate in other clinical trials within the last 4 weeks prior to the current clinical trial.
14. Subjects who are not eligible due to physician's judgment.
Target sample size 46

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 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
Institute Hokkaido Information University
Institute
Department

Funding Source
Organization AMC Consulting, Inc
Organization
Division
Category of Funding Organization Profit organization
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 北海道情報大学 保健センター(北海道)
Hokkaido Information University Health center.

Other administrative information
Date of disclosure of the study information
2017 Year 02 Month 23 Day

Related information
URL releasing protocol
Publication of results Published

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
2016 Year 10 Month 28 Day
Date of IRB
Anticipated trial start date
2017 Year 01 Month 18 Day
Last follow-up date
2017 Year 05 Month 17 Day
Date of closure to data entry
2017 Year 07 Month 04 Day
Date trial data considered complete
2017 Year 07 Month 05 Day
Date analysis concluded
2017 Year 12 Month 31 Day

Other
Other related information

Management information
Registered date
2017 Year 02 Month 21 Day
Last modified on
2018 Year 10 Month 24 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030155

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.