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A examination test of effects on blood pressure by consumption of the test food

A examination test of effects on blood pressure by consumption of the test food - A examination test of effects on blood pressure by consumption of the test food

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000035223
Enrollment
100
Registered
2020-04-20
Start date
2018-12-13
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 adults

Interventions

Test participants intake one package of test food dissolved in 180 mL water 3 times a day 15 min before each meal for 12 weeks. Test participants visit clinic to receive tests on before start of test

Sponsors

CPCC Company Limited
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: (1)Males and females aged 20 to 59 years old when informed consent. (2)Subjects whose body mass index (BMI)is included between 18.5kg/m2 to less than 30.0kg/m2. (3)Subjects who show their systolic blood pressure between 130mmHg to 139mmHg before start of test food consumption or subjects who show their diastolic blood pressure between 85mmHg to 89mmHg before start of test food consumption. (4)Subjects who intake comparably large amount of salt from their daily meals. *Estimated amount of their intake of salt are over 8.0g/day in male and over 7.0g/day in female. (5)Subjects giving written informed consent

Exclusion criteria

Exclusion criteria: (1) Subjects who have a disease or who are given continuous treatment by taking medicines. (2) Subjects who plan to start treatment by taking medicines such as pollen allergy during the test term. (3) Subjects who constantly use oral medicines, functional foods, health foods and/or supplements having a possibility of affecting blood pressure. (4) Smokers (5) Females who are pregnant or lactating, and females who could become pregnant or lactating during test period. (6) Subjects who have previous and/or current medical history of serious disease (e.g., heart, liver, kidney, digestive organ). (7) Subjects who excessive alcohol intake. (8) Subjects who have extremely irregular dining habits, and subjects who have irregular life rhythm such as shift work or midnight work. (9) Subjects who have previous medical history of allergy for drugs, foods (especially for melon and apple), ribgrass pollen and/or lawn pollen. (10) Subjects who are weak to acidic taste (11) 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. (12) Subjects who donated over 200mL blood and/or blood components within the last one month to the current study. (13) Males who donated over 400mL blood within the last three months to the current study. (14) Females who donated over 400mL blood within the last four months to the current study. (15) Males who will be collected over 1200mL blood, when the sampling amounts within the last twelve months are adding to the planned sampling amounts of this study. (16) Females who will be collected over 800mL blood, when the sampling amounts within the last twelve months are adding to the planned sampling amounts of this study. (17) Others who have been determined ineligible by principal investigator or sub-investigator.

Design outcomes

Primary

MeasureTime frame
*Blood pressure

Secondary

MeasureTime frame
*Changing rate of blood pressure *Emission volume of sodium ion in 24-hours urine *Incidence of adverse events and of side effects

Countries

Japan

Contacts

Public ContactMitsuhiro Fujimoto

CPCC Company Limited Planning & Sales Department

cpcc-contact@cpcc.co.j03-5297-3112

Outcome results

None listed

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