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

UMIN ID: UMIN000056131

Registered date:15/11/2024

Basic Information

• Recruitment status: Pending
• Health condition(s) or Problem(s) studied: Healthy subjects
• Date of first enrollment: 2024/11/10
• Target sample size: 9
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

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% gum arabic).

Outcome(s)

• Primary Outcome: 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.

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: Not applicable
• Gender: Male and Female
• Exclude 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.

Related Information

• Primary Sponsor: General Incorporated Association, Kendai Translational Research Center
• Source(s) of Monetary Support: General Incorporated Association Kendai Translational Research Center