Validation of meal coaching based on chrono-nutrition

UMIN ID: UMIN000054137

Registered date:15/04/2024

Basic Information

• Recruitment status: Pending
• Health condition(s) or Problem(s) studied: healthy adults
• Date of first enrollment: 2024/04/03
• Target sample size: 100
• Countries of recruitment: Japan
• Study type: Interventional
• Intervention(s): Conduct a total of 4 ICT interviews (30 minutes per interview) over a 3-month period

Outcome(s)

• Primary Outcome: Amount of change in body weight
• Secondary Outcome: Instruction completion rate, abdominal circumference, blood pressure, laboratory values, psychological level, pre- and post-instruction evaluation of own health status, NPS values,

Key inclusion & exclusion criteria

• Age minimum: 40years-old
• Age maximum: 65years-old
• Gender: Male and Female
• Exclude criteria: 1. Those with a history or current history of serious diseases of the heart, liver, kidney, digestive organs, etc. 2. Pregnant or planning to become pregnant, and those who are breastfeeding. 3. Those who have an extremely irregular diet. 4. Persons who are allergic to food 5. Who are currently participating in a clinical study of another drug or health food, and who plan to participate in another clinical study within one month of the study's completion or after consent to participate in such a study. 6. Do not have a smartphone. 7. Any other person who is deemed by the principal investigator or physician in charge of testing doctor to be inappropriate to participate in this study.

Related Information

• Primary Sponsor: Aikoku Gakuen Junior College
• Secondary Sponsor: Co., Ltd. and Calbee, Inc
• Source(s) of Monetary Support: Calbee, Inc