Skip to content

Safety evaluation

Safety evaluation of intake of ONO-SR/PS for healthy adult part 2 - Safety evaluation of intake of ONO-SR/PS part 2

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000050830
Enrollment
40
Registered
2024-07-20
Start date
2023-04-14
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 test food containing 500mg of ONO-SR/PS for 4 weeks Intake of test food containing 1,000mg of ONO-SR/PS 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 18.5 or more and less than 25 (3) Subjects to measured ECG and stress/fatigue who are appliciable to following items Height Male:155-185cm, Female:150-185cm Bust Male:79-104cm, Female:79-102cm and bust less than E cup Waist Male:less than 94cm, Female:less than 88cm

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 shellfish including fish roe more than 4 times a week (3)Subjects having possibilities for emerging allergy relates to the study (e.g., fish, prawns, crab, and spawn) (4)Subjects who having skin disease (e.g., contact dermatitis, and lacerations) , or sensitive skin on the upper arm or upper body (5)Subjects having a disease requiring treatment or a history of serious diseases (e.g., diabetes, liver disease, kidney disease, heart disease, endocrine disease, metabolic diseases, malignancy, and cancer) for which medication was required including implanted medical device such as cardiac pacemaker, and medical equipment necessary to sustain life such as a monitoring system (6)Subjects who have diseases requiring medication, and treatment except dry eye and cavity protection, or have a history of serious diseases that required medication treatment (7)Subjects who are judges as unsuitable for the study bases on the result of clinical and physical examination on preliminary examination (8)Subjects who are judges 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 are becoming pregnant or intend to become pregnant (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 through the study

Countries

Japan

Contacts

Public ContactTamaki Furuhata

EP Mediate Co., Ltd. Foods Department, Trial Planning Section 1

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

Outcome results

None listed

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