Safety evaluation of an excessive consumption of a plant-derived functional substance . a randomized, double-blind, placebo-controlled trial (g2018012).

Safety evaluation of an excessive consumption of a plant-derived functional substance . a randomized, double-blind, placebo-controlled trial (g2018012). - Safety evaluation of a plant-derived functional substance.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000037230

Enrollment

Registered

2019-07-03

Start date

2019-02-22

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

Nothing(Healthy adults)

Interventions

Control food (placebo). Ingestion of 5 folds dose of recommended daily intake for test food, for 4 weeks. Test food (Food containing plant-derived functional substance). Ingestion of 5 folds dose

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Healthy Japanese adults Normal body weight Normal blood pressure Normal glycometabolism Normal lipid metabolism

Exclusion criteria

Exclusion criteria: Pregnancy / Breast-feeding woman Diabetes mellitus Dyslipidemia Cardiovascular disease Respiratory disease Abnormal liver function Abnormal renal function Endocrine disease Mental disorder Immune disorder Gout Cancer Constant use of oral medication Food allergy Heavy drinker Heavy smoker Inadequate with physician's decision

Design outcomes

Primary

Measure	Time frame
Safety evaluation (adverse events, clinical laboratory test)	—

Countries

Japan

Contacts

Public ContactIsao Takehara

Clinical Support Corporation Limited Food Service Division

takehara@csc-smo.co.jp011-223-3130

Outcome results

None listed

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