Safety evaluation of long-term intake of Fermented barley GABA 90 %.

Safety evaluation of long-term intake of Fermented barley GABA 90 %. -Placebo-controlled, double-blind, randomized, parallel-group comparative study- - Safety evaluation of long-term intake of Fermented barley GABA 90 %. -Placebo-controlled, double-blind, randomized, parallel-group comparative study-

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000047209

Enrollment

Registered

2022-03-18

Start date

2022-03-18

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 subjects

Interventions

Intake of test food for 13 consecutive weeks Intake of placebo for 13 consecutive weeks

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: (1) Subjects of men and women aged 20 to 64 (2) Subjects who received sufficient explanation about the purpose and content of the test, had the ability to consent, voluntarily volunteered to participate after understanding it well, and agreed to participate in the test in writing

Exclusion criteria

Exclusion criteria: (1) Subjects with heart, liver, and kidney diseases (including complications of other diseases) (2) Subjects with a history of cardiovascular disease (3) Subjects with diabetes (4) Subjects with diseases currently being treated (5) Subjects who are allergic to food and drugs (6) Subjects with anemia symptoms (7) Female subjects wishing to become pregnant while participating in this study, pregnant (including those who may be pregnant) or lactating female subjects (8) Subjects who go to the hospital for some illness or are treated with drugs and Chinese medicine (temporary administration is possible) (9) Subjects who play intense sports and subjects who are on a diet (10) Subjects with extremely irregular eating habits (11) Subjects who cannot stop taking health foods (including foods for specified health use and foods with functional claims) and quasi-drugs during the test period (12) Subjects who drink more than 60 g of average daily pure alcohol (13) Subjects who smoke an average of 21 or more cigarettes a day (14) Subjects who are participating in or will participate in other clinical trials at the start of this study (15) Subjects who were vaccinated against infectious diseases such as influenza and COVID-19 within 1 month before SCR (16) Other subjects judged by the investigator or the investigator to be inappropriate for the examination

Design outcomes

Primary

Measure	Time frame
Adverse event Physical test value Laboratory test values	—

Countries

Japan

Contacts

Public ContactMakoto Terashima

Oneness Support Co., Ltd. Clinical Trial Division

mterashima@oneness-sup.co.jp0648018917

Outcome results

None listed

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