A clinical trial to evaluate the safety of ingestion in overdose (five times recommended dose) of functional food ingredient for 4 weeks.

A clinical trial to evaluate the safety of ingestion in overdose (five times recommended dose) of functional food ingredient for 4 weeks. - A clinical trial to evaluate the safety of ingestion in overdose (five times recommended dose) of functional food ingredient for 4 weeks.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000055908

Enrollment

Registered

2025-04-01

Start date

2024-11-08

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

Intake of the test food containing five times recommended dose of lemon myrtle extract for 4 weeks. Intake of the placebo food for 4 weeks.

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Healthy males and females aged 20-74 years

Exclusion criteria

Exclusion criteria: (1) Subjects who are judged as unsuitable for this study in lifestyle habits (e.g., extremely unbalanced or fluctuating diet, irregular meal times, heavy alcohol consumption (average daily consumption of 20 g or more of pure alcohol), night work, day/night shift work, irregular days off, etc.) (2) Subjects who are heavy smokers (more than 21 cigarettes a day) (3) Subjects who are taking medication (4) Subjects who have a disease under treatment (5) Subjects with a history or current history of serious diseases of sugar metabolism, lipid metabolism, liver function, renal function, heart, circulatory system, respiratory system, endocrine system, immune system, or nervous system (6) Subjects with frequent symptoms of diarrhea (7) Subjects who are judged as unsuitable for this study based on the clinical examination and blood pressure measurement in screening test (8) Subjects who participated in any other clinical trial (any clinical study using cosmetics, foods, drugs, quasi-drugs, medical devices, etc.) in 8 weeks or have plan to participate in any other clinical trial during this study (9) Subjects with food allergies (10) Subjects who are pregnant or lactating, or who wish to become pregnant during this study (11) Subjects who are judged as unsuitable for this study by investigators in othe reasons

Design outcomes

Primary

Measure	Time frame
Adverse events, medical interview, clinical laboratory tests (hematology test, blood biochemistry test, urine test) and physical examination (blood pressure, heart rate),	—

Countries

Japan

Contacts

Public ContactHiroaki Furusyo

DRC Co., Ltd Testing Department, Cosmetics and Food Effectiviness Testing Group

furusyo@drc-web.co.jp06-6882-1130

Outcome results

None listed

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