Study on the Effects of Consuming Food Containing Sardine-Derived Peptide Extract on Vascular Endothelial Function

UMIN ID: UMIN000055426

Registered date:05/09/2024

Basic Information

• Recruitment status: Pending
• Health condition(s) or Problem(s) studied: Male/female adults
• Date of first enrollment: 2024/09/06
• Target sample size: 36
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

Oral intake of the test food 1 (4 tablets, once daily) for 8 weeks
Oral intake of the test food 2 (4 tablets, once daily) for 8 weeks
Oral intake of the placebo food (4 tablets, once daily) for 8 weeks

Outcome(s)

• Primary Outcome: Flow-Mediated Dilation (FMD) values
• Secondary Outcome: Nitric Oxide (NOx) levels Pulse Wave Velocity (PWV) values

Key inclusion & exclusion criteria

• Age minimum: 40years-old
• Age maximum: 70years-old
• Gender: Male and Female
• Exclude criteria: 1. Subjects who cannot discontinue the use of Foods for Specified Health Uses (FOSHU), Foods with Functional Claims, or health supplements (including those containing procyanidin B1 and B3, bonito-derived elastin peptides, black soybean polyphenols, etc) that may affect vascular endothelial function from the time of consent acquisition. 2. Subjects currently undergoing medication treatment (excluding eye drops and nasal sprays). 3. Subjects who are participating in the other clinical trials and/or who have participated in the other clinical trials within 4 weeks prior to the current trial and/or who are planning to participate in the other clinical trials. 4. Subjects with excessive alcohol intake. 5. Subjects who smoke heavily (not less than 21 cigarettes a day) 6. Subjects with previous and/or current medical history of serious diseases in heart, liver, kidney and/or digestive organs. 7. Females who are pregnant or lactating, and females who could become pregnant during the trial period. 8. Subjects with allergies to medications and/or food. 9. Subjects who donated blood or a component (200 mL) within the last 1 month. 10. Male subjects who donated their blood (400 mL) within the last 3 months. 11. Female subjects who donated their blood (400 mL) within the last 4 months. 12. Male subjects whose collected blood volume in total would reach more than 1200 mL within the last 12 months and in this study. 13. Female subjects whose collected blood volume in total would reach more than 800 mL within the last 12 months and in this study. 14. Subjects deemed unsuitable for participation in the trial by the principal investigator or sub-investigator.

Related Information

• Primary Sponsor: CPCC Company Limited
• Source(s) of Monetary Support: Senmi Ekisu Co., Ltd.