A Double-Blind, Placebo-Controlled Study for Effects of Daily Oral Administration of "Dattan Soba Seikatsu" on Blood pressure and Blood flow improvement.

A Double-Blind, Placebo-Controlled Study for Effects of Daily Oral Administration of "Dattan Soba Seikatsu" on Blood pressure and Blood flow improvement. - Effect of Daily Oral Administration of "Dattan Soba Seikatsu" on Blood pressure and blood flow.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000026254

Enrollment

Registered

2017-02-23

Start date

2017-01-18

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy adults

Interventions

Ingestion of Dattan Soba Seikatsu for 12 weeks. Ingestion of placebo capsule for 12 weeks.

Eligibility

Sex/Gender

All

Inclusion criteria

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.

Exclusion criteria

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.

Design outcomes

Primary

Measure	Time frame
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.	—

Secondary

Measure	Time frame
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).	—

Countries

Japan

Contacts

Public ContactDir. Prof. Jun NISHIHIRA, M.D., Ph.D.

Hokkaido Information University Health Information Science center

nishihira@do-johodai.ac.jp011-385-4430

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026

A Double-Blind, Placebo-Controlled Study for Effects of Daily Oral Administration of &quot;Dattan Soba Seikatsu&quot; on Blood pressure and Blood flow improvement.