Effects of a Drink Containing Fermented Soba Extract (neo-FBS) on the Decrease of Blood Pressure

Not Applicable

• Conditions: /A(healthy adults with normal high blood pressure or Grade 1 hypertension

• Registration Number: JPRN-UMIN000020470
• Lead Sponsor: TES Holdings Co., Ltd.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-01-07
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: All
• Target Recruitment: 64

Inclusion Criteria

Not provided

Exclusion Criteria

[1]Individuals using medical products [2]Individuals whose condition is secondary hypertension (ex. renal artery stenosis, renal hypertension, renovascular hypertension, pheochromocytoma, disease of adrenal cortex) [3]Individuals who have a history of bronchial disease (ex. asthma, tuberculosis, pleurisy) [4]Individuals who have a history of serious hepatopathy, kidney damage, heart disease and hematological disease [5]Individuals who are sensitive to a food containing soba and test product or other foods, and medical products [6]Individuals who have a history of hepatitis [7]Individuals with serious anemia [8]Individuals whose BMI is over 30 [9]Individuals who have a habit of smoking [10]Individuals who excessively take alcohol (expressed in an amount of alcohol: over 60mg/day) [11]Individuals whose life style will change during the test period (ex. a night shift, travel for a long time, job transfer) [12]Individuals who had a habit to ingest health-promoting foods, foods for specified health uses, health foods, or supplyments in the past 3 month or will ingest those foods during the test period [13]Individuals who participated in other clinical studies in the past three months [14]Individuals who donated blood over 200mL in the past 1 month or over 400mL in the past 3 months [15]Individuals who are or are posslibly, or are lactating [16]Individuals judged inappropriate for the study by the principal

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
[1]Blood pressure, pulsation (Screening, Week 0, Week 4, Week 8, Week 12)

Secondary Outcome Measures

Name	Time	Method
[1]Adrenal medulla test (Week 0, Week 12) [2]Hematologic test [3]Blood biochemical test [4]Urine analysis [5]Hight(Screening) [6]Weight, body fat percentage, BMI (Screening, Week 0, Week 4, Week 8, Week 12) [7]Doctor's questions (Screening, Week 0, Week 4, Week 8, Week 12) [8]Subject's diary(From the first day of ingestion of a test material to the last day of the test)