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Safety evaluation of an excessive consumption of Bilberry extract and Lutein

Safety evaluation of an excessive consumption of Bilberry extract and Lutein - Safety evaluation of an excessive consumption of Bilberry extract and Lutein

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000025414
Enrollment
20
Registered
2016-12-26
Start date
2016-12-26
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

Nothing (healthy subject)

Interventions

Bilberry extract 240mg and Lutein 120mg,4weeks

Sponsors

Omnica Co.,Ltd
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Healthy Japanese males and females 2. BMI>=18.5 and <25 kg/m2

Exclusion criteria

Exclusion criteria: 1. Subjects who have at least one previous medical history of malignant tumor, heart failure or myocardial infarction 2. Subjects who are patient or have history of cardiac arrhythmia, hepatic disorder, renal disorder, cerebrovascular disorder, rheumatism, diabetes mellitus, dyslipidemia, hypertension or other chronic diseases 3. Subjects who have undergone gastrointestinal tract surgery; except appendectomy 4. Subjects who are currently taking medicines (include herbal medicines) and/or supplements 5. Subjects who are allergic to medicines or the test material of this trial 6. Subjects who are or are possibly pregnant, or are lactating 7. Subjects who participate in other clinical trials in the past 3 months 8. Subjects who work time is irregular 9. Subjects who have been determined ineligible by principal investigator for other reasons

Design outcomes

Primary

MeasureTime frame
Hematologic test (0w,2w,4w,6w)

Secondary

MeasureTime frame
Body measurement(0w,6w) Blood biochemical test (0w,2w,4w,6w) Urine analysis (0w,2w,4w,6w) Doctor's questions (0w,6w) Adverse events

Countries

Japan

Contacts

Public ContactMarie Kosehira

Omnica Co.,Ltd Research and development Dept.

kosehira@omnica.co.jp03-5840-9811

Outcome results

None listed

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