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The verification study for safety evaluation of excessive the test beverage ingestion in humans: a randomized, double-blind, placebo-controlled, parallel study

The verification study for safety evaluation of excessive the test beverage ingestion in humans: a randomized, double-blind, placebo-controlled, parallel study - The verification study for safety evaluation of excessive the test beverage ingestion in humans

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000032455
Enrollment
40
Registered
2018-05-02
Start date
2018-05-02
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 adult people

Interventions

Duration: 4 weeks Follow-up duration: 2 weeks Test material: Calcium-blended lemon beverage Dosage: Drink 3 bottles (350 mL per bottle) of test beverage per day in 3 separate times at any time of t

Sponsors

ORTHOMEDICO Inc.
Lead Sponsor
Medical Corporation Seishinkai, Takara Clinic
Collaborator

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Healthy Japanese adult people 2. Subjects who are judged 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 disease: cardiac arrhythmia, liver failure, kidney failure, cerebrovascular disorder, rheumatism, diabetes mellitus, dyslipidemia, hypertension, or any other chronic diseases 3. Subjects who have a medical history of calculus 4. Subjects who are under the treatment of osteoporosis 5. Subjects who use or take "Foods for Specified Health Uses", "Foods with Functional Claims", or other functional food/beverage in daily 6. Currently taking medicines (include herbal medicines) and supplements 7. Subjects who take fortified food/beverage with calcium in daily 8. Subjects who are allergic to medicines and/or the test beverage related products 9. Subjects who was on medication for hay fever for the last 3 years 10. Subjects who are pregnant, lactation, and planning to become pregnant 11. Subjects who have been enrolled in other clinical trials within the last three months before the agreement to participate in this trial 12. 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 4. Subjective symptoms (the Likert scale) * Assess at screening and examination before consuming, at 2 and 4 weeks after ingestion, and follow-up period for 2 weeks

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