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A study for safety evaluation of excess consumption of calcium.

A study for safety evaluation of excess consumption of calcium. - A study for safety evaluation of excess consumption of calcium.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000031447
Enrollment
20
Registered
2018-02-25
Start date
2018-02-26
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

Oral intake of the test foods (255g in a day for 4 weeks)

Sponsors

CPCC Company Limited
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: (1)Healthy adults aged 20 to 64 years old. (2)Subjects giving written informed consent.

Exclusion criteria

Exclusion criteria: (1)Subjects who are given continuous treatment by taking medicines. (2)Individuals who excessively take calcium (total(test foods and usual meals) amount of calcium over 2500mg/day). (3)Subjects who have previous and/or current medical history of kidney stones, Ureteral stones. (4)Subjects who constantly use oral medicines, functional foods and/or supplements having a possibility of affecting test results. (5)Subjects who have previous and/or current medical history of serious disease (e.g., heart, liver, kidney, digestive organ). (6)Females who are pregnant or lactating, and females who could become pregnant or lactating during test period. (7)Subjects who excessive alcohol intake. (8)Subjects who have extremely irregular dining habits, and subjects who have midnight work or irregular shift work. (9)Subjects who have previous medical history of drug and/or food allergy. (10)Subjects who are participating the other clinical tests. Subjects who participated within 4-weeks prior to the current study and/or who plan to participate the other clinical tests. (11)Subjects who donated over 200mL blood and/or blood components within the last one month to the current study. (12)Subjects who donated over 400mL blood and/or blood components within the last three month to the current study. (13)Females who donated over 400mL blood and/or blood components within the last four month to the current study. (14)Males who will be collected over 1200mL blood and/or blood components, when the sampling amounts within the last twelve month are adding to the planned sampling amounts of this study. (15)Females who will be collected over 800mL blood and/or blood components when, the sampling amounts within the last twelve month are adding to the planned sampling amounts of this study. (16)Others who have been determined ineligible by principal investigator or sub-investigator.

Design outcomes

Primary

MeasureTime frame
Existence of side effects and adverse events(Week 0, Week 2, Week 4, 2 weeks after the end of ingestion of a test food)

Secondary

MeasureTime frame
Doctor's questions, Blood pressure, pulsation, Weight, body fat percentage, BMI, Blood biochemical test, Hematologic test, Urine analysis (Week 0, Week 2, Week 4, 2 weeks after the end of ingestion of a test food)

Countries

Japan

Contacts

Public ContactHiroyuki Mitsumoto

Maruha Nichiro Corporation Central Research Institute

h-mitsumoto@maruha-nichiro.co.jp029-864-6712

Outcome results

None listed

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