NIPH Clinical Trials Search

A study to evaluate the safety of excessive consumption of the test food

Basic Information

Recruitment status	Complete: follow-up complete
Health condition(s) or Problem(s) studied	Healthy Japanese
Date of first enrollment	2024/12/20
Target sample size	20
Countries of recruitment	Japan
Study type	Interventional
Intervention(s)	Active group: SG-1 Active ingredient: Salacinol Consumption of the active food containing five times the recommended daily intake of the active ingredient for four weeks Placebo group: Placebo Consumption of placebo for four weeks

Outcome(s)

Primary Outcome	1. Individuals who experienced adverse events
Secondary Outcome	1. Individuals whose values of blood test and urinalysis are outside the reference range after intervention despite within the reference range at screening (before intervention)

Key inclusion & exclusion criteria

Age minimum	20years-old
Age maximum	Not applicable
Gender	Male and Female
Include criteria
Exclude criteria	1. Individuals who are undergoing medical treatment or have a medical history of malignant tumor, heart failure, or myocardial infarction 2. Individuals who have a pacemaker or an implantable cardioverter defibrillator (ICD) 3. Individuals who are currently undergoing treatment for any of the following chronic diseases: cardiac arrhythmia, liver disorder, chronic kidney disease, cerebrovascular disorder, rheumatic disease, diabetes mellitus, dyslipidemia, hypertension, or any other chronic diseases 4. Individuals who are taking "Foods for Specified Health Uses" or "Foods with Functional Claims" 5. Individuals who are taking or using medications (including herbal medicines) or supplements 6. Individuals who are allergic to medicines or foods related to the test product, particularly those allergic to herbs 7. Individuals who are pregnant, lactating, or planning to become pregnant during this study 8. Individuals who have been enrolled in other clinical studies within the last 28 days before the agreement to participate in this study or plan to participate in another study during this study 9. Individuals who are judged as ineligible to participate in this study by the physician