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A verification study of safety evaluation of excessive the yeast materials ingestion in humans: a randomized, double-blind, placebo-controlled, parallel study.

A verification study of safety evaluation of excessive the yeast materials ingestion in humans: a randomized, double-blind, placebo-controlled, parallel study. - Safety evaluation of excess ingestion of the yeast in humans.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000032942
Enrollment
30
Registered
2018-06-20
Start date
2018-06-20
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

Intake of Food containing yeast-derived protein once a day for 4 weeks. Intake of placebo without yeast-derived protein once a day for 4 weeks.

Sponsors

Pharma Foods International Co., Ltd
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1)Males and females from 20 to 65 years of age. 2)Subjects who are deagnosed as eligible to participate in the study by the physician

Exclusion criteria

Exclusion criteria: 1)A medical history of malignant tumor, heart failure or myocardial infarction. 2) Currently undergoing treatment for any of the following chronic diseases: atrial fibrillation, cardiac arrhythmia, liver failure, kidney failure, cerebrovascular disorder, rheumatism, diabetes mellitus, dyslipidemia, hypertension, or any other chronic diseases 3) Subjects who currently taking medications (including herbal medicines) 4) Subjects who are allergic to medications and/or the test food related products. 5) Subjects who are pregnant, breast-feeding, or planning to become pregnant. 6) Subjects who are judged as ineligible to participate in the study by the physician.

Design outcomes

Primary

MeasureTime frame
1. Physical examination 2. Urinalysis 3. Blood test * Assess these tests at screening and examination before consumption, at 2 and 4 weeks after consumption and 2 weeks after consumption completed.

Countries

Japan

Contacts

Public ContactUtano Nakamura

Pharma Foods International Co., Ltd. Research and Development Department

u-nakamura@pharmafoods.co.jp075-394-8605

Outcome results

None listed

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