Clinical trial protocol for Rye hull extract

JRCT ID: jRCT1030210671

Registered date:17/03/2022

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Non-alcoholic steatohepatitis preventive effect test in health conditios with high hepatitis marker.
• Date of first enrollment: 06/01/2021
• Target sample size: 40
• Study type: Interventional
• Intervention(s): A cracker containing a rye extract containing 2 grams of alkylresorcinol as a constituent lipid is fed once a day.

Outcome(s)

• Primary Outcome: Body weight, abdominal circumference, blood triglyceride level, blood cholesterol level, blood AST level, blood ALT level, blood sugar level
• Secondary Outcome: Bristol stool scale and Stool frequency.

Key inclusion & exclusion criteria

• Age minimum: >= 21age old
• Age maximum: < 65age old
• Gender: Both
• Include criteria: Healthy individuals with a body mass index (BMI) value of 23 or higher.
• Exclude criteria: Recipient of a diabetes or hepatitis drug.

Related Information

• Primary Sponsor: Imai Shinjiro