Safety evaluation studies of long-term consumption of food containing resistant glucan (water-soluble dietary fiber) in healthy subjects or subjects with high triglyceride levels or pre-diabetic subjects

Safety evaluation studies of long-term consumption of food containing resistant glucan (water-soluble dietary fiber) in healthy subjects or subjects with high triglyceride levels or pre-diabetic subjects - Safety evaluation studies of long-term consumption of food containing resistant glucan (water-soluble dietary fiber) in healthy subjects or subjects with high triglyceride levels or pre-diabetic subjects

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000018527

Enrollment

Registered

2015-08-21

Start date

2015-08-22

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

Healthy adult

Interventions

Ingestion of the test product for 12 weeks

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: (1) Healthy adult males and females from 20 to 64 years of age (2) Subjects falling under any of the following A. triglyceride levels are ranged from 120 mg/dL to 199 mg/dL (10 or more subjects) B. blood fasting glucose levels are ranged from 110 mg/dL to 125 mg/dL (10 or more subjects) C. triglyceride levels are less than 120 mg/dL and blood fasting glucose levels are less than 110 mg/dL (10 or more subjects)

Exclusion criteria

Exclusion criteria: (1) Subjects having a disease requiring treatment or a history of serious diseases, diabetes, hepatopathy, renal or heart disease (2) Subjects having possibilities for emerging allergy related to the study (3) Subjects having a disease requiring treatment or a history of serious diseases for which medication was required (4) Subjects who are judged as unsuitable for the study based on the results of clinical and physical examination on preliminary examination (5) 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 (6) Subjects who intend to become pregnant or lactating (7) Subjects who are judged as unsuitable for the study based on the results of lifestyle questionnaire (8) Subjects judged as unsuitable for the study by the investigator for other reasons

Design outcomes

Primary

Measure	Time frame
Adverse event	—

Countries

Japan

Contacts

Public ContactYuki Kitahara

TTC Co.,Ltd. Clinical Research Planning Department

y.kitahara@ttc-tokyo.co.jp03-5459-5329

Outcome results

None listed

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