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A study for safety evaluation of excess consumption of the test drink.

A study for safety evaluation of excess consumption of the test drink. - Safety evaluation of excess consumption of the test drink.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000033160
Enrollment
16
Registered
2019-06-27
Start date
2018-06-28
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

The drink which contains indigestible dextrin. Intake four weeks.

Sponsors

CPCC Company Limited
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: (1)Males and females aged 20 to 64years old. Contain around four subjects whose fasting neutral fat level is 120mg/dL to 199mg/dL. (2) Subjects who receive enough explain of the test, who deeply understanding of the test, and who obtain own consent to participate the test.

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 constitution of weak stomach and of tendency of diarrhea. (4) Females who are pregnant or lactating, and females who could become pregnant or lactating during test period. (5)Subjects who have previous and/or current medical history of serious disease (e.g., heart, liver, kidney, digestive organ). (6)Subjects who excessive alcohol intake. (7)Subjects who have extremely irregular dining habits, and subjects who have midnight work or irregular shift work. (8)Subjects who have previous medical history of drug and/or food allergy. (9) 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. (10)Subjects who donated over 200mL blood and/or blood components within the last one month to the current study. (11) Subjects who donated over 400mL blood and/or blood components within the last three month to the current study. (12) Females who donated over 400mL blood and/or blood components within the last four month to the current study. (13) 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. (14) 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. (15)Others who have been determined ineligible by principal investigator or sub-investigator.

Design outcomes

Primary

MeasureTime frame
Presence or absence of, kind of, severity of, frequency of, side effects and adverse events, involved abnormal variations of the clinical test data.

Secondary

MeasureTime frame
Presence or absence of abnormal variations in clinical tests data.

Countries

Japan

Contacts

Public ContactMasanori Numa

CPCC Company Limited Planning & Sales Department

info@cpcc.co.jp03-5297-3112

Outcome results

None listed

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