Safety evaluation study of excessive consumption of dietary fiber-containing brend tea beverage

Safety evaluation study of excessive consumption of dietary fiber-containing brend tea beverage - Safety evaluation study of excessive consumption of dietary fiber-containing brend tea beverage

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000029752

Enrollment

Registered

2017-10-30

Start date

2017-10-30

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

None listed

Interventions

Ingestion of 3-fold dietary fiber of recommended daily intake in test food for 4 weeks.

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: (1)Japanese adult male and female from 20 to 69 years old at the time of acquiring consent. (2)Healthy subjects whose physical examination findings and clinical laboratory findings do not deviate greatly from the normal values at the time of screening. (3)Subjects with triglyceride values from 150 - 199 mg/dL, and whose physical examination findings and clinical laboratory findings do not deviate greatly from the normal values at the time of screening. (4)Subjects who are available at every designated hospital visit. (5)Subjects who agree to participate in this study and can put signature and date to informed consent form by themselves prior to the study.

Exclusion criteria

Exclusion criteria: (1)Subjects with hepatic, renal, cardiac or organ disorders, diabetes, or other serious diseases. (2)Subjects with a surgical history of digestive system (except appendicectomy). (3)Subjects with chronic diseases under treatment. (4)Subjects who are pregnant or lactating, or intend to become pregnant during the study. (5)Subjects who consume excessive alcohol (equivalent to more than 540 mL/day of sake or 1,500 mL/day of 5% beer or such) for 5 days or more per week. (6)Subjects who are aware of having weak stomach or difficulties of taking brend tea beverages. (7)Subjects who have experienced allergic reactions to foods containing brend tea ingredients (8)Subjects judged as unsuitable for the study by principal investigator for other reasons.

Design outcomes

Primary

Measure	Time frame
Safety evaluation items: Examination by a physician in charge, Physical examination findings, Clinical laboratory findings (Hematological test, Biochemical test, Urine analysis), Subjective symptoms	—

Countries

Japan

Contacts

Public ContactRyota Wakimoto

Medical Corporation Hokubukai Utsukushigaoka Hospital Clinical Pharmacology Center

wakimoto@ughp-cpc.jp011-882-0111

Outcome results