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Clinical pharmacological test of calcium alginate capsules. - Optimization study of postprandial serum triglyceride elevation suppression effect -

Clinical pharmacological test of calcium alginate capsules. - Optimization study of postprandial serum triglyceride elevation suppression effect (reanalysis) - - Optimization test of postprandial serum triglyceride elevation suppression effect of calcium alginate capsules (reanalysis).

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000056131
Enrollment
9
Registered
2024-11-15
Start date
2024-11-10
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 subjects

Interventions

Placebo capsules are taken at the same time as fat-loaded food (corn oil suspended in 3% gum arabic). Test substance capsules are taken at the same time as fat-loaded food (corn oil suspended in 3% gu

Sponsors

General Incorporated Association, Kendai Translational Research Center
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Males and females aged 20 years or older at the time of informed consent. In principle, those whose fasting blood TG level at the time of screening test is less than 150mg/dL. Those who fully understand the purpose and safety of this research specified in the research cooperation consent form and have obtained consent.

Exclusion criteria

Exclusion criteria: Persons receiving treatment, medication, or lifestyle guidance from a doctor due to dyslipidemia or diabetes. People who regularly use medicines, health foods, or supplements that affect blood lipids. Persons who have some kind of disease and are receiving medication and are deemed unsuitable as subjects by the research doctor. Persons who may have allergic symptoms related to rubber or latex. Persons who may develop allergic symptoms regarding fat-loaded foods (corn oil, etc.). Persons whose HIV antigen/antibody, HBs antigen, HCV antibody, or syphilis test result was positive at the time of screening. Persons with obvious abnormalities found in hematological or biochemical tests. Those who are pregnant, wish to become pregnant during the test, or are breastfeeding. Persons whose TGdeltaC3h (estimated TGCmax) is less than 30 mg/dL in the screening test. Those who have been diagnosed with bronchial asthma and are receiving treatment, or those who have received treatment in the past.

Design outcomes

Primary

MeasureTime frame
The area under the curve (AUC, delta C) of the postprandial serum triglyceride. The serum triglyceride level C. delta C. The maximum concentration (Cmax, delta Cmax) of the postprandial serum triglyceride.

Countries

Japan

Contacts

Public ContactSatsuki Kimura

General Incorporated Association, Kendai Translational Research Center Clinical Research Department

kimura.ktrc@gmail.com0273954316

Outcome results

None listed

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