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A study for safety evaluation of 12-weeks consumption of the food containing algae

A study for safety evaluation of 12-weeks consumption of the food containing algae - A study for safety evaluation of 12-weeks consumption of the food containing algae

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000036101
Enrollment
40
Registered
2020-03-07
Start date
2019-03-07
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 adults

Interventions

Intake test food once a day at dinner time for 12 weeks. Intake control food once a day at dinner time for 12 weeks.

Sponsors

CPCC Company Limited
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) Healthy males and females aged 20 to 64 years old when consent acquisition. 2) Subjects who have received enough explanation about this study and were able to understand that, then giving written informed consent.

Exclusion criteria

Exclusion criteria: 1) Subjects who are likely to cause allergies against test food especially algae and/or seaweeds. 2) Subjects who are given continuous treatment by taking medicines. 3) Subjects who have previous and/or current medical history of serious disease (e.g., heart, liver, kidney, digestive organ). 4) Females who are pregnant or lactating, and females who could become pregnant or lactating during test period. 5) Subjects who excessive alcohol intake. 6) Subjects who have moderate symptom of pollen allergy. 7) Subjects who are participating the other clinical tests. Subjects who participated within three month prior to the current study and/or who plan to participate the other clinical tests. 8) Subjects who donated over 200mL blood and/or blood components within the last one month to the current study. 9) Subjects who donated over 400mL blood and/or blood components within the last three month to the current study. 10) Females who donated over 400mL blood and/or blood components within the last four month to the current study. 11) Males who will be collected over 1200mL blood and/or blood components, when the sampling amounts within the last twelve month are adding to the planned sampling amounts of this study. 12) Females who will be collected over 800mL blood and/or blood components when, the sampling amounts within the last twelve month are adding to the planned sampling amounts of this study. 13) Others who have been determined ineligible by principal investigator or sub-investigator.

Design outcomes

Primary

MeasureTime frame
1) The incidence of side effects and/or adverse events. 2) The results of clinical examination.

Countries

Japan

Contacts

Public ContactMakoto Ichinohe

CPCC Company Limited Planning & Sales Department

cpcc-contact@cpcc.co.jp03-5297-3112

Outcome results

None listed

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