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A clinical study to evaluate the safety of plant-extracts containing foods. (SME-2021-06)

A clinical study to evaluate the safety of plant-extracts containing foods. (SME-2021-06) - A clinical study to evaluate the safety of plant-extracts containing foods.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000046825
Enrollment
48
Registered
2022-02-06
Start date
2022-02-07
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

None listed

Interventions

Sponsors

Suntory Beverage & Food Limited
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: (1) Those who are -> 20 years old at the time of IC acquisition and <65 years old at the end of food intake. (2) Those who have LDL cholesterol of -<119 md/dL or 120~139 md/dL or 140~159 mg/dL/ (3) Those who have submitted written informed consent after fully understanding the purpose and content of this study.

Exclusion criteria

Exclusion criteria: (1) Those with systolic blood pressure less than 90mmHg at the start of ingestion. (2) Women who are/might be pregnant or lactating during the study. (3) Those who have taken >=200mL whole blood or blood donation within 4 weeks before the start of the intake. (4) Men who have taken =>400mL whole blood within 12 weeks before the start of intake. (5) Women who have taken =>400mL whole blood within 16 weeks before the start of intake. (6) Men who have taken =>1,200mL whole blood total (including the sampling of this study) within 12 months before the start of intake. (7) Women who have taken =>800mL whole blood total (including the sampling of this study) within 12 months before the start of intake. (8) Those who are participating in other study or planning to participate or participated within the past 4 weeks. (9) Those who meet any of the following: a) suffering from heart, liver, or kidney disease (including complications of other diseases) b) having a history of cardiovascular disease c) diabetes d) allergic to food e) having a history of cancer or tuberculosis f) positive or false-positive by infectious disease test (10) Those who are receiving any treatment at the time of screening. (11) Those who regularly use pharmaceuticals (including quasi-drugs), foods for specified health use, foods with functional claims or health foods. (12) Those who smoke an average of 21 or more cigarettes in a day. (13) Those who drink an average of more than 60 g of pure alcohol in a day. (14) Those who have an extremely irregular eating habit. (15) Shift workers or late-night workers. (16) Others who are judged inappropriate for participant by the investigator.

Design outcomes

Primary

MeasureTime frame
Incidence of adverse reactions

Secondary

MeasureTime frame
Incidence of adverse events Laboratory data, Vital sign

Countries

Japan

Contacts

Public ContactKaori MATSUOKA

Suntory Beverage & Food Limited Development & Design Department

Kaori_Matsuoka@suntory.co.jp050-3182-0550

Outcome results

None listed

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