NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
UMIN ID: UMIN000053632

Registered date:16/02/2024

A clinical study to evaluate the safety of food ingredients.(SWE-2023-10-HCRINK)

Basic Information

Recruitment status Pending
Health condition(s) or Problem(s) studiedNot applicable
Date of first enrollment2024/02/20
Target sample size48
Countries of recruitmentJapan
Study typeInterventional
Intervention(s)Daily intake of test food for 4 weeks. Daily intake of control food for 4 weeks.

Outcome(s)

Primary OutcomeIncidence of adverse reactions
Secondary OutcomeIncidence of adverse events Laboratory data, Vital sign

Key inclusion & exclusion criteria

Age minimum20years-old
Age maximum65years-old
GenderMale and Female
Include criteria
Exclude criteria(1) Those with systolic blood pressure less than 90 mmHg. (2) Women who wish to become pregnant, are/might be pregnant or lactating during the study. (3) Those who have taken >=200 mL whole blood or blood donation within 4 weeks before the start of the intake. (4) Men who have taken =>400 mL whole blood within 12 weeks before the start of intake. (5) Women who have taken =>400 mL whole blood within 16 weeks before the start of intake. (6) Men who have taken =>1,200 mL whole blood total (including the sampling of this study) within 12 months before the start of intake. (7) Women who have taken =>800 mL 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 test 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.

Related Information

Contact

public contact
Name Misaki Onozato
Address 2-3-3 Daiba, Minato-ku, Tokyo. Japan 135-8631
Telephone 050-7134-6116
E-mail Misaki_Onozato@suntory.co.jp
Affiliation Suntory Holdings Limited Research Strategy Planning Department
scientific contact
Name Hidenori Obata
Address 8-1-1 Seikadai, Seika-cho, Soraku-gun, Kyoto. Japan
Telephone 050-3182-0568
E-mail Hidenori_Obata@suntory.co.jp
Affiliation Suntory Wellness Limited Institute For Science of Life