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Safety evaluation

Safety evaluation of excessive intake of ONO-SR/AST-SOYPC for healthy adults - Safety evaluation of excessive intake of ONO-SR/AST-SOYPC

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000039269
Enrollment
30
Registered
2021-04-25
Start date
2020-02-04
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/AST-SOYPC, recommended daily intake, for 4 weeks Intake of ONO-SR/AST-SOYPC 2-fold quantity of recommended daily intake, for 4 weeks Intake of ONO-SR/AST-SOYPC 5-fold quantity of reco

Sponsors

TTC Co., Ltd.
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Healthy males and females from 20 to 64 years of age

Exclusion criteria

Exclusion criteria: (1) Subjects who constantly use health food richly containing involvement ingredient (2) Subjects having a disease requiring treatment or a history of serious diseases for which medication was required (3) Subjects having possibilities for emerging allergy related to the study (4) Subjects having a disease requiring treatment or a history of serious diseases for which medication was required (5) Subjects having a drug dependence, alcohol dependence requiring treatment or a history of serious alcohol dependence (6) Subjects who are judged as unsuitable for the study based on the results of clinical and physical examination on preliminary examination (7) Subjects who have participated in other clinical study within the last one month prior to the current study or are planned to participate in other clinical study after informed consent for the current study (8) Subjects who intend to become pregnant or lactating (9) Subjects who are judged as unsuitable for the study based on the results of lifestyle questionnaire (10) 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 2, 4 weeks after intake and 2 weeks after the end of intake period and Adverse events thorough the study

Countries

Japan

Contacts

Public ContactTakashi Nakagawa

TTC Co., Ltd. Clinical Research Planning Department

t.nakagawa@ttc-tokyo.co.jp03-5459-5329

Outcome results

None listed

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