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A Study on the Effect of Food Containing Polydextrose on Postprandial Serum Triglyceride -A Randomized, Double-blind, Placebo-controlled, Cross-over Study-

A Study on the Effect of Food Containing Polydextrose on Postprandial Serum Triglyceride -A Randomized, Double-blind, Placebo-controlled, Cross-over Study- - The Effect of Food Containing Polydextrose on Postprandial Serum Triglyceride

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000014538
Enrollment
90
Registered
2014-07-15
Start date
2014-07-16
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 high fasting serum triglyceride)

Interventions

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 120 mg/dL to 199 mg/dL. (3)Subjects who can make self-judgment and are voluntarily giving written informed consent.

Exclusion criteria

Exclusion criteria: (1)Subjects who use oral medication affecting lipid metabolism. (2)Subjects who constantly use supplements and/or functional foods (including Food for Specified Health Uses) affecting lipid metabolism. (3)Subjects who can't stop drinking for 2 days before the screening checkup or each measurement. (4)Subjects who have declared allergic reaction to ingredients contained in high-fat diets. (5)Subjects who contract or are under treatment for serious diseases (e.g., diabetes, liver disease, kidney disease, and/or heart disease), thyroid gland disease, adrenal gland disease, and/or metabolic disorder. (6)Subjects who have a chronic disease and use medicines continuously. (7)Subjects who have a history of digestive disease affecting digestion and absorption. (8)Subjects who are judged as unsuitable for the study based on the results of blood tests by the investigator. (9)Subjects who have donated over 200 mL of blood and/or blood components within the last one month prior to the current study or over 400 mL of blood and/or blood components within the last three months prior to the current study. (10)Subjects who are diagnosed as familial hyperlipidemia. (11)Subjects who are diagnosed as anemic and not suitable for frequent collection of blood. (12)Subjects who are under treatment for or have a history of drug addiction and/or alcoholism. (13)Subjects who are planning to participate in other clinical studies. (14)Subjects who are planning to become pregnant after informed consent for the current study or are pregnant or lactating. (15)Subjects who are judged as unsuitable for the study by the investigator for other reasons.

Design outcomes

Primary

MeasureTime frame
Postprandial Serum Triglyceride

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