An investigation on the safety of excessive consumption of coffee

UMIN ID: UMIN000034289

Registered date:27/09/2018

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: N/A(People with a BMI of at least 18.5kg/m2 and less than 25kg/m2.)
• Date of first enrollment: 2018/10/15
• Target sample size: 20
• Countries of recruitment: Japan
• Study type: Interventional
• Intervention(s): Coffee three times a day (three times the standard amount of daily consumption) for 4 weeks

Outcome(s)

• Primary Outcome: <Safety> -Interview by physician -Height, body weight and BMI -Blood pressure and pulse -Hematological test -Biochemical test -Urine analysis -Adverse events

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: 65years-old
• Gender: Male and Female
• Exclude criteria: 1. People who have very irregular dietary habits 2. People on continuous treatment with medication 3. People with medicine or food allergies 4. People using medicine, foods for specified health uses, foods with functional claims, supplements, or diet products that may have an effect on the study 5. People with hypertension , diabetes mellitus, dyslipidemia ,or other lifestyle-related diseases 6. People with gastrointestinal dysfunction, significant liver dysfunction, significant kidney dysfunction, or significant cardiovascular disease 7. People with a history of a gastrectomy/extensive digestive tract excision 8. People with dependence on drugs or alcohol 9. People who are pregnant, nursing, or plan to become pregnant 10. Other people determined to be unsuitable for participation in the study by the principal investigator

Related Information

• Primary Sponsor: Yutaka Kanamaru
• Source(s) of Monetary Support: Key Coffee Inc.