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A verification study of blood amino acid levels

A verification study of blood amino acid levels: a randomized, placebo-controlled, double-blind, parallel-group comparison study - A verification study of blood amino acid levels

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000046434
Enrollment
20
Registered
2021-12-22
Start date
2021-12-23
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 Japanese subjects

Interventions

Duration: Four weeks Test food: Plant-origin nano-sized lactic acid bacterium SNK Protein load: Super Crunchy Chocolate Administration: &lt
Take one packet per day with water in the morning &lt
Protein load&gt
Take protein load two hours before blood sampling on the test day * If you forget to take the test food, take it as soon as you remember within the day. Duration: Four weeks Test food: Placebo (de
Take protein load two hours before blood sampling on the test day * If you forget to take the test food, take it as soon as you remember within the day.

Sponsors

ORTHOMEDICO Inc.
Lead Sponsor
Medical Corporation Seishinkai, Takara Clinic Nerima Medical Association, Minami-machi Clinic
Collaborator

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Japanese 2. Male or female 3. Subjects aged 40 or more 4. Healthy subjects 5. Subjects who are judged as eligible to participate in the study by the physician 6. Subjects whose blood amino acid levels are relatively low

Exclusion criteria

Exclusion criteria: 1. Subjects who are undergoing medical treatment or have a medical history of malignant tumor, heart failure, and myocardial infarction 2. Subjects who have a pacemaker or an implantable cardioverter defibrillator (ICD) 3. Subjects currently undergoing treatment for any of the following chronic disease: cardiac arrhythmia, liver disorder, kidney disorder, cerebrovascular disorder, rheumatism, diabetes mellitus, dyslipidemia, hypertension, or any other chronic diseases 4. Subjects who take "Foods for Specified Health Uses", "Foods with Functional Claims", or other functional food/beverage in daily use 5. Subjects currently taking medicines (include herbal medicines) and supplements 6. Subjects who are allergic to medications and/or the test-food-related products 7. Subjects who are pregnant, breast-feeding, and planning to become pregnant 8. Subjects who suffer from COVID-19 9. Subjects who have been enrolled in other clinical trials within the last 28 days before the agreement to participate in this trial or plan to participate another trial during this trial 10. Subjects who are judged as ineligible to participate in the study by the physician

Design outcomes

Primary

MeasureTime frame
Total amino acid levels in blood

Secondary

MeasureTime frame
Essential amino acid levels in blood

Countries

Japan

Contacts

Public ContactNaoko Suzuki

ORTHOMEDICO Inc. R&D Department

nao@orthomedico.jp03-3818-0610

Outcome results

None listed

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