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Safety evaluation for intake of Test Diet: Placebo-controlled double-blind randomized parallel study

Safety evaluation for intake of Test Diet: Placebo-controlled double-blind randomized parallel study - Safety evaluation for intake of Test Diet

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000043126
Enrollment
30
Registered
2021-05-31
Start date
2021-01-27
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 individuals

Interventions

Ingestion of test food for 4 weeks Ingestion of control food for 4 weeks

Sponsors

Miura Clinic, Medical Corporation Kanonkai
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: (1) Subjects of men and women aged 20 to 64 (2) Subjects with a BMI of less than 25 kg / m2 (3) Subjects who received sufficient explanation about the purpose and content of the test, had the ability to consent, voluntarily volunteered to participate after understanding it well, and agreed to participate in the test in writing.

Exclusion criteria

Exclusion criteria: (1) Persons with a history of liver disease, renal disease, digestive system disease, heart disease, diabetes, or other diseases that may affect the results of this study, or subjects with a history of surgery (2) Subjects with abnormal liver function and renal function test values (3) Subjects with diseases currently being treated (4) Subjects taking warfarin (5) Subjects with anemia symptoms (6) Subjects showing abnormal blood test values (7) Subjects who are judged by the investigator to not participate in the study (8) Subjects with food and drug allergies (9) Subjects who play intense sports and subjects who are on a diet (10) Subjects who cannot stop taking health foods (including foods for specified health use and foods with functional claims) and quasi-drugs during the test period (11) Subjects who are continuously taking medicines (including OTC and prescription medicines) (12) Subjects who are excessively ingesting alcohol or who cannot stop drinking from the day before the test to the day of the test (13) Subjects with smoking habits (14) Subjects with an irregular lifestyle and a lifestyle that reverses day and night (15) Subjects who have a habit of drinking and eating (16) Subjects who are pregnant or plan to become pregnant or breastfeed during the study period (female only) (17) Subjects who are participating in or will participate in other clinical trials at the start of this study. (18) Subjects who donated 200 mL or more of blood from the month before the start of the test to the start of the test, or those who are scheduled to do so during the test period

Design outcomes

Primary

MeasureTime frame
Adverse event Physical examination Hematological test Blood biochemical test Urinalysis

Countries

Japan

Contacts

Public ContactMakoto Terashima

Oneness Support Co., Ltd. Clinical Trial Division

mterashima@oneness-sup.co.jp06-4801-8917

Outcome results

None listed

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