Safety of Overconsumption of a Functional Food on Healthy Adult Males and Females.

UMIN ID: UMIN000055496

Registered date:13/09/2024

Basic Information

• Recruitment status: Pending
• Health condition(s) or Problem(s) studied: No
• Date of first enrollment: 2024/09/23
• Target sample size: 12
• Countries of recruitment: Japan
• Study type: Interventional
• Intervention(s): Oral intake of the test food 5 capsules in a day; 4 weeks).

Outcome(s)

• Primary Outcome: Existence and its contents of side effects: expression number and expression rate of side effects (expression rate: number of cases/number of cases analyzed). (Week 0, Week 2, Week 4)
• Secondary Outcome: *Secondary outcomes 1) Physical xamination (Week 0, Week 2, Week 4). 2) Biochemical examination (Week 0, Week 2, Week 4). 3) Doctor's questions (Week 0, Week 2, Week 4). 4) Adverse events: number of cases and expression rate of adverse events (expression rate: number of cases/number of cases analyzed) (Week 0, Week 2, Week 4). * Efficacy Exploratory Index 1) Blood and fecal special tests (Week 0, Week 4).

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: 65years-old
• Gender: Male and Female
• Exclude criteria: 1) Individuals using medical products. 2) Individuals who are patient or have a history of psychiatric disease, high blood pressure, diabetes, and hyperlipidemia. 3) Individuals who used a drug to treat a disease in the past 1 month. 4) Individuals who have a history of serious hepatopathy, kidney damage, heart disease and hematological disease. 5) Individuals who are a patient or have a history of or endocrine disease. 6) Individuals who have been diagnosed and are under treatment for functional constipation at a medical institution. 7) Individuals who are determined to have chronic constipation in the diagnostic criteria for chronic constipation. 8) Individuals whose BMI is less than 18.5kg/m2 and over 30kg/m2. 9) Individuals with systolic blood pressure 140 mmHg or higher, diastolic blood pressure 90 mmHg or higher, pulse 85 beats/min or higher. 10) Individuals who donated blood over 200mL in the past 1 month or over 400mL in the past 3 months. 11) Individuals who experienced unpleasant feeling during blood drawing. 12) Individuals with drug and food allergies. 13) Individuals who have been regularly using food for specified health use, functional foods, or health foods in the past 3 months or at present. 14) Individuals who have a habit of consuming yogurt and fermented foods rich in lactic acid bacteria. 15) Individuals who excessively take alcohol (expressed in an amount of alcohol: over 30g/day). 16) Individuals with possible changes of life style during the test period. 17) Individuals who are pregnant, breastfeeding, or who may become pregnant during the study period. 18) Individuals who participated in other clinical studies in the past 3 months. 19) Individuals who are or whose family is engaged in healthy or functional foods. 20) Individuals judged inappropriate for the study by the principal.

Related Information

• Primary Sponsor: TES Holdings Co., Ltd.
• Source(s) of Monetary Support: Nicorio Co., Ltd.