Preliminary investigation of concerning human immune parameters.

Not Applicable

• Conditions: Male/female adults

• Registration Number: JPRN-UMIN000045264
• Lead Sponsor: CPCC Company Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-08-28
• Study Completion: 2021-11-26
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: All
• Target Recruitment: 66

Inclusion Criteria

Not provided

Exclusion Criteria

(1)Subjects who are regularly consuming food for specified health uses (FOSHU), food with function claims, supplement and/or health foods which would affect the study results for more than 3 days a week. (2)Subjects who have a plan or who have taken medication (e.g., antibiotics, steroids, antihistamines), which would affects the study results. (3)Subjects who take excessive alcohol. (4)Subjects who are participating or have participated in another clinical study with medicine/food within the last 4 weeks before this study, or are planning to join those after giving informed consent. (5)Subjects who will be vaccinated with various vaccines during the month leading up to the test-1 and during the test period (e.g., those who are waiting for an appointment or standby for coronavirus vaccination). (6)Subjects who have current medical history/anamnesis of severe cardiac, hepatic, renal or digestive diseases. (7)Subjects who are pregnant, lactating, or intend to become pregnant during the study period. (8)Subjects who are allergic to drugs or foods. (9-11)Subjects who have been donated their blood components and/or whole blood prior to the pre-inspection as follows: - males/females: 200 mL of blood components within a month - males: 400 mL of whole blood within the last 3 months - females: 400 mL of whole blood within the last 4 months. (12-13)Subjects who have been donated their blood within the last 12 months, which would reaches to the following volume after adding their blood amount planning to be collected in this study; - males: 1,200 mL - females: 800 mL (14)Subjects with systolic blood pressure of 180 mmHg or higher, and/or diastolic blood pressure of 110 mmHg or higher. (15) Others who have been determined ineligible by principal/sub investigator.

Study & Design

• Study Type: Observational
• Study Design: Not specified