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Setting of test food intake

Setting of test food intake - Setting of test food intake

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000053868
Enrollment
30
Registered
2024-03-14
Start date
2024-03-15
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 adult

Interventions

Consecutive intake of 10g of test food once a day for 15 days Consecutive intake of 20g of test food once a day for 15 days

Sponsors

EP Mediate Co., Ltd.
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: (1) Healthy males and females from 18 to 29 years of age (2) Subjects whose BMI is less than 20 kg/m2 (3) Subjects who defecate more than 3 times a week without laxative (4) Subjects receiving a sufficient briefing of the objective and content of the present study, fully understanding and agreeing to voluntarily participate in the study and being able to personally sign a written informed consent

Exclusion criteria

Exclusion criteria: (1) Subjects who have a positive or false positive result in any infectious disease test or who are carriers (2) Subjects who have a soybean allergy or who have experienced symptoms such as rash, redness, or difficulty in breathing due to eating soybean products containing soybean flour or soy milk (3) Subjects who may develop allergies in relation to the study (4) Subjects who are taking healthy foods (5) Subjects who are prescribed laxatives or medicines or quasi-drugs that affect the intestinal flora and are taking them more than once a month (6) Subjects who have with a disease being treated (excluding dry eye/caries treatment) or a disease requiring treatment (grade II hypertension, diabetes, etc.) (7) Subjects who have had abnormalities in clinical laboratory values or cardiopulmonary function, and are judged to have a problem participating in the study (8) Subjects who have a disease that requires constant medication (seasonal medication etc.), those who have a disease under treatment, those who have a history of serious disease that required medication, and those who are scheduled for surgery (9) Subjects whose physical measurements, physical examination values, and clinical examination values before the start of intake were significantly out of the reference range (10) Subjects who work in shifts, work late at night, and have an irregular daily rhythm before the test day, or subjects who living conditions do not allow them to consume test food every day during the designated period (11) Subjects who are participating in the other study within one month before the start of this study (12) Subjects who plan overseas trip, domestic long-term trip or domestic frequent trips (13) Subjects who plan to become pregnant or breastfeed during the study period (14) Subjects who are judged to be unsuitable as subjects based on the answers to the background survey (15) Subjects who are judged as unsuitable for the study by the investigator for other reason

Design outcomes

Primary

MeasureTime frame
blood amino acid concentration

Secondary

MeasureTime frame
Body composition

Countries

Japan

Contacts

Public ContactKaori Yoshimura

EP Mediate Co., Ltd. R&D Support Center Foods Department Trial Planning Section 1

yoshimura.kaori265@eps.co.jp080-1193-3234

Outcome results

None listed

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