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A study for safety evaluation of 12-weeks consumption of the drink containing indigestible dextrin.

A study for safety evaluation of 12-weeks consumption of the drink containing indigestible dextrin. - A study for safety evaluation of 12-weeks consumption of the drink containing indigestible dextrin.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000018446
Enrollment
30
Registered
2015-07-29
Start date
2015-07-29
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

Drink which is contain indigestible dextrin 5g as dietary fiber. Intake 350mL/day, 12 weeks. Drink which is not contain indigestible dextrin. Intake 350mL/day, 12 weeks.

Sponsors

CPCC Company Limited
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: (1)Subjects giving written informed consent (2)Healthy males and females aged 20 to 64 years old. (3) Subjects who falls under any of the following criteria. A. Fasting blood glucose levels at preliminary test are less than 100mg/dL. (around 18 subjects) B. Fasting blood glucose levels at preliminary test are between more than 100mg/dL and less than 126mg/dL. (around 12 subjects)

Exclusion criteria

Exclusion criteria: (1)Subjects who are given continuous treatment by taking medicines. (2) Subjects who constantly use oral medicines, functional foods and/or supplements having a possibility of affecting test results. (3)Subjects who have previous and/or current medical history of serious disease (e.g., heart, liver, kidney, digestive organ). (4) Females who are pregnant or lactating, and females who could become pregnant or lactating during test period. (5)Subjects who excessive alcohol intake. (6) Subjects who have extremely irregular dining habits, and subjects who have midnight work or irregular shift work. (7)Subjects who have previous medical history of drug and/or food allergy. (8) Subjects who are participating the other clinical tests. Subjects who participated within 4-weeks prior to the current study and/or who plan to participate the other clinical tests. (9)Subjects who donated over 200mL blood and/or blood components within the last one month to the current study. (10) Subjects who donated over 400mL blood and/or blood components within the last three month to the current study. (11) Females who donated over 400mL blood and/or blood components within the last four month to the current study. (12) Males who will be collected over 1200mL blood and/or blood components, when the sampling amounts within the last twelve month are adding to the planned sampling amounts of this study. (13) Females who will be collected over 800mL blood and/or blood components when, the sampling amounts within the last twelve month are adding to the planned sampling amounts of this study. (14)Others who have been determined ineligible by principal investigator or sub-investigator.

Design outcomes

Primary

MeasureTime frame
The incidence of side effects

Secondary

MeasureTime frame
Blood test Urine test Blood pressure/pulsation Weight/body mass index Medical interview

Countries

Japan

Contacts

Public ContactMakoto Ichinohe

CPCC Company Limited Plan Sales Department

m.i@cpcc.co.jp03-5297-3112

Outcome results

None listed

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