A Trial to Evaluate HbA1c Reduction after 8 Weeks Ingestion of Inulin-Containing Food - Double Blind Randomized Placebo-Controlled Parallel Group Study -

A Trial to Evaluate HbA1c Reduction after 8 Weeks Ingestion of Inulin-Containing Food - Double Blind Randomized Placebo-Controlled Parallel Group Study - - A Trial to Evaluate HbA1c Reduction after 8 Weeks Ingestion of Inulin-Containing Food

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000038428

Enrollment

Registered

2019-10-29

Start date

2019-10-30

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

Daily ingestion of inulin-containing food for 8 weeks. Daily ingestion of placebo food for 8 weeks.

Eligibility

Sex/Gender

Male

Inclusion criteria

Inclusion criteria: (1) Adult males from 20 to 64 years old at the time of giving consent. (2) Individuals with HbA1c values from 5.6 to <6.5 % at the time of screening. (3) Individuals who are available at every designated hospital visit. (4)Individuals 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)Individuals who have history of serious gastrointestinal disease, liver disease, kidney disease, cardiovascular disease, blood disease, endocrine system disease, or malignant neoplasm, or individuals who are suspected to have these diseases. (2) Individuals currently taking oral medication for internal diseases or receiving medical treatment. (3) Individuals planning to take medicine or to receive medical treatment during in this study. (4) Individuals planning to continuously take health food product or a supplement that indicates reduction of blood glucose and/or diabetes prevention during this study. (5) Individuals who have possibility of changing a lifestyle (i.e. night work, long travel or transfer) (6) Individuals with excessive alcohol drinking or heavy smoking (7) Individuals who may have allergies to Asteraceae plants in relation to the test food. (8) Individuals currently participating or planning to participate in any other clinical studies. (9) Individuals judged as inappropriate for the trial by the principal investigator.

Design outcomes

Primary

Measure	Time frame
Change in HbA1c from baseline value	—

Secondary

Measure	Time frame
HbA1c (measured), insulin (change and measured), insulin (change and measured), CPR(change and measured), HOMA-R, and intestinal flora (Bifidobacterium)	—

Countries

Japan

Contacts

Public ContactTakuya Matsuda

Medical Corporation Hokubukai Utsukushigaoka Hospital Clinical Pharmacology Center

matsuda@ughp-cpc.jp0118820111

Outcome results