Safety evaluation of excessive intake of food containing HYA for healthy adults.

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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000029357

Enrollment

Registered

2017-09-29

Start date

2017-10-01

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

Consumption of food containing HYA for 5-fold Quantity of recommended daily intake, for 4 weeks.

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: (1) Males and females from 20 to 69 years of age (2) Subjects falling under any of the following A. fasting blood glucose levels are less than 110 mg/dL or 2-hour glucose levels in 75 g OGTT are less than 140 mg/dL (about 10 subjects) B. fasting blood glucose levels are ranged 110 to 125 mg/dL or 2-hour glucose levels in 75 g OGTT are ranged 140 to 199 mg/dL (about 10 subjects)

Exclusion criteria

Exclusion criteria: (1) Subjects who routinely use health food containing large amount of unsaturated fatty acids or health food for diet (2) Subjects who constantly use oral medication and/or functional foods which may affecting serum lipid levels, lipid metabolism and/or glycometabolism (3) Subjects who have under treatment or a history of serious disease(e.g., diabetes, liver disease, kidney disease, or heart disease) (4) Subjects having possibilities for emerging allergy related to the test food (5) Subjects having a disease requiring treatment or a history of serious diseases for which medication was required (6) Subjects who are judged as unsuitable for the current study based on the results of clinical and physical preliminary examination (7) Subjects who have participated in other clinical studies within the last one month prior to the current study or are planned to participate in other studies after obtaining informed consent for the current study (8) Subjects who intend to become pregnant or lactating (9) Subjects who are judged as unsuitable for the current study based on the results of lifestyle questionnaire (10) Subjects judged as unsuitable for the current study by the investigator

Design outcomes

Primary

Measure	Time frame
Hematologic test Blood biochemistry test Urine test Blood pressure/pulsation Weight/body mass index Medical Interview Adverse event	—

Countries

Japan

Contacts

Public ContactShinsuke Tsuji

TTC Co., Ltd. Clinical Research Planning Department

s.tsuji@ttc-tokyo.co.jp03-5459-5329

Outcome results

None listed

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