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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000050420
Enrollment
6
Registered
2023-02-25
Start date
2023-02-25
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

Healthy subjects

Interventions

Stage1: Placebo capsule Stage2: Test substance A capsule Stage3: Test substance B capsule Fat Loading Food d: Corn Oil Suspended with 5% Gum Arabic After eating the fat loading food within 3 min

Sponsors

Takasaki University of Health and Welfare
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Males and females aged 20 years or older at the time of informed consent. Subjects with a BMI value of 22 or more and less than 25 at the time of informed consent. 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: Those who are taking dyslipidemia drugs. (Persons receiving treatment for hyperlipidemia) If the participant has some kind of disease and is under medication, and the cooperating doctor deems the participant unsuitable as a subject. Subjects who may have allergic symptoms to rubber or latex. Subjects who may have allergic symptoms to corn oil. If any of the results of HIV antigen/antibody, HBV, HCV, and syphilis tests at screening are positive. Subjects with obvious abnormalities in hematological and biochemical tests. Those who are pregnant, those who wish to become pregnant during the test, and those who are breastfeeding.

Design outcomes

Primary

MeasureTime frame
The maximum concentration (Cmax) of the postprandial serum triglyceride. The area under the curve (AUC) of the postprandial serum triglyceride. The serum triglyceride level (before, 30, 60, 90, 120, 240 and 360 minutes after the fat food load).

Countries

Japan

Contacts

Public ContactSatsuki Kimura

Takasaki University of Health and Welfare Faculty of Pharmacy

s-kimura@taksaki-u.ac.jp0273521180

Outcome results

None listed

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