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Safety evaluation

Safety evaluation of intake of ONO-SR/PS for healthy adults part1 - Safety evaluation of intake of ONO-SR/PS part1

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000048716
Enrollment
10
Registered
2023-11-08
Start date
2022-08-23
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 ONO-SR/PS, recommended daily intake, for 4 weeks Intake of ONO-SR/PS 2-fold quantity of recommended daily intake, for 4 weeks

Sponsors

EP Mediate Co., Ltd
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: (1)Healthy males and females from 20 to 64 years of age (2)BMI 18 or more and less than 25

Exclusion criteria

Exclusion criteria: (1)Subjects who constantly use health food richly containing DHA, EPA, astaxanthin and shark liver oil involvement ingredient more than 1 times a week (2)Subjects who having habit of fish and selfish (including fish roe) more than 4 times a week (3)Subjects having possibilities for emerging allergy related to the study (e.g., fish, prawns, crab and spawn) (4)Subjects who having skin disease, sensitive skin on the upper arm or serious diseases for which medication was required (5)Subjects having a disease requiring treatment or a history of serious diseases for which medication was required (6)Subjects who have diseases that require constant me dication, or who have a history of serious diseases that required medication treatment except dry eye and cavity protection (7) Subjects who are judged as unsuitable for the study based on the results of clinical and physical examination on preliminary examination (8)Subjects who are judged as unsuitable for the study based on the results of lifestyle questionnaire (9)Subjects judged as unsuitable for the study based on the results of clinical examination or cardiopulmonary abnormality in the past (10)Subjects who are participating in other clinical research at the start of this study (11)Subjects who intend to become pregnant or lactating (12)Subjects judged as unsuitable for the study by the investigator for other reasons

Design outcomes

Primary

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

Countries

Japan

Contacts

Public ContactTamaki Furuhata

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

furuhata.tamaki686@eps.co.jp070-3023-8207

Outcome results

None listed

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