UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000026254
Receipt number 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 15:09:49

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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 or person

Institute

Hokkaido Information University

Institute

Department

Personal name



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

Value
https://center6.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