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A Clinical Study for Evaluating the Safety of Excessive Consumption of Food Containing Polydextrose A Randomized, Double-blind, Placebo-controlled, Parallel-group Study

A Clinical Study for Evaluating the Safety of Excessive Consumption of Food Containing Polydextrose A Randomized, Double-blind, Placebo-controlled, Parallel-group Study - A Clinical Study for Evaluating the Safety of Excessive Consumption of Food Containing Polydextrose

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000016000
Enrollment
30
Registered
2014-12-24
Start date
2014-12-25
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

No(subjects with fasting serum triglyceride levels 30-199 mg/dL)

Interventions

Food containing polydextrose, 3-fold quantity of recommended daily intake Food not containing polydextrose

Sponsors

KSO Corporation
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: (1)Healthy males and females aged 20 to 64 years old (2)Subjects whose fasting serum triglyceride levels are from 30 mg/dL to 199 mg/dL (3)Subjects who can stop drinking from 2 days before each measurement (4)Subjects who can make self-judgment and are voluntarily giving written informed consent

Exclusion criteria

Exclusion criteria: (1)Subjects who use medications affecting obesity, hyperlipidemia, lipid metabolism, and so on (2)Subjects who can't stop using supplements and/or functional foods affecting obesity, hyperlipidemia, lipid metabolism, and so on (3)Subjects who contract serious diabetes, kidney disease, liver disease, and/or disease needing immediate treatment, and who are taking relevant medicines (4)Subjects who have a history of digestive disease affecting digestion and absorption, and related surgery (5)Subjects who are under treatment for or have a history of drug addiction and/or alcoholism (6)Subjects who have been diagnosed as familial hyperlipidemia (7)Subjects who are planning to become pregnant after informed consent for the current study or are pregnant or lactating (8)Subjects who have donated blood components and/or blood a volume of 200 mL and over within one month prior to the current study (9)Subjects who are planning to participate or already participating in other clinical studies (10)Subjects who are judged as unsuitable for the study by the investigator for other reasons

Design outcomes

Primary

MeasureTime frame
Biochemical examination, Hematological examination, urine analysis, vital signs

Countries

Japan

Contacts

Public ContactYoshika Komori

KSO Corporation Sales department

yoshi@kso.co.jp03-3452-7733

Outcome results

None listed

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