UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A Double-Blind, Placebo-Controlled Study for Effects of Daily Oral Administration of "Dattan Soba Seikatsu" on Blood pressure and Blood flow improvement.
Title of the study (Brief title)	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	Prof. Jun NISHIHIRA, M.D., Ph.D.
Organization	Hokkaido Information University
Division name	Department of Medical Management and Informatics
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	Dir. Prof. Jun NISHIHIRA, M.D., Ph.D.
Organization	Hokkaido Information University
Division name	Health Information Science center
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 10 Month 28 Day
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

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