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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000055426
Enrollment
36
Registered
2024-09-05
Start date
2024-09-06
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

Male/female adults

Interventions

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 week

Sponsors

CPCC Company Limited
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Men and women aged 40 to below 70 years at the time of consent acquisition. 2. Subjects with a BMI between 23.0 and less than 30.0. 3. Subjects who can give informed consent to partake in this study, after being provided with an explanation of the protocol detail.

Exclusion criteria

Exclusion 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.

Design outcomes

Primary

MeasureTime frame
Flow-Mediated Dilation (FMD) values

Secondary

MeasureTime frame
Nitric Oxide (NOx) levels Pulse Wave Velocity (PWV) values

Countries

Japan

Contacts

Public ContactMasanori Numa

CPCC Company Limited Clinical Planning Department

cpcc-contact@cpcc.co.jp03-6225-9001

Outcome results

None listed

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