A study to examine the postprandial levels of blood and urine parameters by test meal intake

UMIN ID: UMIN000055538

Registered date:20/09/2024

Basic Information

• Recruitment status: Pending
• Health condition(s) or Problem(s) studied: Healthy volunteers
• Date of first enrollment: 2024/10/13
• Target sample size: 10
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

Intake of a test meal -> Intake of a control meal
Intake of a control meal -> Intake of a test meal

Outcome(s)

• Primary Outcome: analysis of 40 amino acids
• Secondary Outcome: blood analysis: triglycerides, glucose urinalysis: Na, K, Na/K

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: 65years-old
• Gender: Male and Female
• Exclude criteria: 1) Subjects receiving a medical treatment for serious cardio-vascular, hepatic, renal, respiratory, endocrine or metabolic disorders or having a medical history of these disorders 2) Subjects whose BMI is less than 18.5 kg/m2 or 30.0 kg/m2 or more 3) Subjects drinking a lot (subjects whose pure alcohol intake per day is 60 g or more) 4) Subjects having the possibility of developing allergic symptoms by the test meal 5) Subjects whose lifestyles are irregular because of night shift or others 6) Subjects regularly taking food being rich in amino acids or proteins (supplement, beverage, etc.) 7) Subjects regularly taking medicines or quasi-drugs containing amino acids as an active ingredient 8) Subjects having blood sample of 200 ml or more taken within 1 month, or 400 ml or more within 3 months prior to the start of the present study (e.g. donated blood) 9) Female subjects who are pregnant or lactating, or intending to become pregnant during the study 10) Subjects who took part in another clinical study within 3 months prior to the start of the present study or who is currently taking part in another clinical study 11) Subjects deemed unsuitable by the investigator

Related Information

• Primary Sponsor: NICHIREI FOODS INC.
• Source(s) of Monetary Support: None