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Safety evaluation of excessive intake of food containing Pomegranate Punicalagin for healthy adults

Safety evaluation of excessive intake of food containing Pomegranate Punicalagin for healthy adults - Safety evaluation of excessive intake of food containing Pomegranate Punicalagin for healthy adults

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000057396
Enrollment
44
Registered
2025-04-04
Start date
2025-04-07
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 adult

Interventions

Intake of food containing Pomegranate Punicalagin, 5-fold quantity of recommended daily intake, for 4 weeks Intake of food not containing Pomegranate Punicalagin, for 4 weeks

Sponsors

EP Mediate Co., Ltd.
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: (1) Male and female aged 20 to 64 (2) Subjects who fully understand the purpose and content of this study and voluntarily agree to participate in the study

Exclusion criteria

Exclusion criteria: (1) Subjects who have already been intaking food, pharmaceuticals, or quasi-drugs enhanced with Pomegranate Punicalagin at least once a week during the pre-examination (2) Subjects who intake pomegranates or pomegranate juice three or more days a week (3) Subjects who have had abnormalities in clinical test values or liver function or cardiopulmonary function and are judged to be unsuitable for participation in the study (4) Subjects who are at risk of developing allergies related to the study (5) Subjects with a disease requiring regular medication (Both external and internal medications), with a disease currently being treated (excluding dry eyes and tooth decay) or with a history of a serious disease that required medication (6) Subjects whose pre-intake test results are significantly outside the reference range (7) Subjects who work in shifts, late-night shifts, or have other irregular lifestyles (8) Subjects who have participated or plan to participate in other studies within one month of the start of the study (9) Subjects who intend to become pregnant or lactating (10) Subjects who are judged to be unsuitable for participation in the study based on their responses to the lifestyle questionnaire (11) Subjects who are judged as unsuitable for the study by the investigator for other reason

Design outcomes

Primary

MeasureTime frame
Hematologic test, Blood biochemistry test, Urine test, Blood pressure/pulsation, Weight/body mass index, Medical Interview, before and 2, 4 weeks after intake and 2 weeks after the end of intake period and Adverse events thorough the study

Countries

Japan

Contacts

Public ContactSaki Fukuchi

EP Mediate Co., Ltd. Development Department Trial Planning Section

fukuchi.saki473@eps.co.jp090-1400-7556

Outcome results

None listed

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