Skip to content

Safety evaluation of a single intake of a test food containing Plant extract

Safety evaluation of a single intake of a test food containing Plant extract- an open-label, single arm study - Safety evaluation of a single intake of a test food containing Plant extract

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000048998
Enrollment
10
Registered
2023-09-15
Start date
2022-09-16
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

Single intake of recommended daily dosage of test food containing Plant extract followed by single intake of its 3 times ,then aingle intake of its 5 times with 6 days or more intervals.

Sponsors

FANCL Corporation
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Japanese males and females aged 20- and 65 at the time of informed consent 2. Subjects who can be available to the study site on the visiting dates 3. Subjects who consented to participate in the study prior to the start of the study and be able to sign and date the consent document by themselves.

Exclusion criteria

Exclusion criteria: 1. Subjects with a serious medical history and those suffering from hepatic disorder, renal or cardiac disease, organ failure, diabetes mellitus, or other serious diseases 2. Subjects with a history of gastrointestinal resection (except for appendicectomy) 3. Subjects with chronic diseases under treatment 4. Subjects who are at risk of developing an allergy in relation to the study 5. Subjects who are aware that the frequency of defecation or stool characteristics may easily change significantly as gastrointestinal symptoms. 6. Heavy drinkers of alcohol (>60 g/day of pure alcohol) or excessive smokers (>20 cigarettes/day) or smokers who cannot quit smoking during the study under unified control. 7. Pregnant or planning to become pregnant or breastfeeding during the study period 8. Subjects who work late at night, work overtime for a long period of time, or work the irregular shifts 9. Subjects who are participating in other study in which test foods or drugs are taken, or in which cosmetics or drugs are applied, or who plan to participate in other study during the study period. 10. Subjects who may need to avoid consuming the food or beverage used in the study with religious or other reasons, since the origin of the ingredients are not specified. 11. Those who are judged to be unsuitable as subjects based on the results of the background survey. 12. Subjects whose physical or clinical examination data prior to the start of intake are significantly out of the reference range. 13. Subjects who are judged to be inappropriate to participate in this study by the investigator.

Design outcomes

Primary

MeasureTime frame
Subjective symptoms, physician's examination findings, physical examination, clinical examination

Countries

Japan

Contacts

Public ContactIsao Takehara

Clinical Support Corporation, Ltd. Food Service Division

takehara@csc-smo.co.jp011-223-3130

Outcome results

None listed

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