Safety evaluation of excessive intake of food containing plant extract for healthy adults.

Safety evaluation of excessive intake of food containing plant extract for healthy adults. - Safety evaluation of excessive intake of food containing plant extract.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000042646

Enrollment

Registered

2022-03-01

Start date

2020-12-21

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 plant extract, recommended daily intake, for 4 weeks Intake of food containing plant extract, 2-fold of recommended daily intake, for 4 weeks Intake of food containing plant

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 or medicine richly containing involvement ingredient (2) Subjects routinely taking medicine or health food which may influence bowel movement. (3) Subjects having a large amount of foods which may influence bowel movement such as food containing dietary fiber and lactic acid bacteria. (4) Subjects visiting the hospital for diseases related bowel movements and using drugs, or using commercial laxative. (5) Subjects having diseases or a history of drug addiction or alcoholism. (6) Subjects who are under treatment or have a history of serious disease (e.g., diabetes, liver disease, kidney disease, or heart disease). (7) Subjects having possibilities for emerging allergy related to the study. (8) Subjects who are under medication or having a history of serious diseases for which medication was required. (9) Subjects who are judged as unsuitable for the study based on the results of clinical and physical examination on preliminary examination. (10) 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. (11) Subjects who are planned to become pregnant after informed consent for the current study or are pregnant or lactating. (12) Subjects who are judged as unsuitable for the study based on the results of lifestyle questionnaire. (13) Subjects judged as unsuitable for the study by the investigator for other reasons.

Design outcomes

Primary

Measure	Time frame
Hematologic test Blood biochemistry test Urine analysis Blood pressure/pulsation Weight/BMI Doctor's questions Adverse event Stool output, defecation frequency, defecation days, fecal condition	—

Countries

Japan

Contacts

Public ContactShingo Yamamichi

TTC Co., Ltd. Clinical Research Planning Department

yamamichi578@eps.co.jp03-5657-4983

Outcome results

None listed

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