Functional evaluation of cholesterol level reduction in humans

UMIN ID: UMIN000048222

Registered date:04/07/2022

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: Healthy adult
• Date of first enrollment: 2022/07/04
• Target sample size: 60
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

Intake research food 3 tablets daily for 12 weeks
Intake placebo 3 tablets daily for 12 weeks

Outcome(s)

• Primary Outcome: LDL-cholesterol
• Secondary Outcome: Total cholesterol, HDL-cholesterol, LDL cholesterol-HDL cholesterol ratio, non-HDL cholesterol, Atherogenic index, triglycerides special clinical examination items (sd LDL cholesterol, oxidized LDL cholesterol, remnant-like lipoprotein-cholesterol)

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: 64years-old
• Gender: Male and Female
• Exclude criteria: (1) Those who regularly intake foods, health foods, or medicines that are rich in active ingredients of research foods. (2) Those who are currently, or within the past 3 months have been, in the habit of continuously intaking foods with functional claims or health foods that claim to be related to lipid or glucose metabolism, or are planning to intake such foods during the study period. (3) Those with a history of dyslipidemia, hypertension, diabetes, psychiatric disorders, sleep disorders, or serious illnesses, or a history of continuous drug treatment. (4) Those with a BMI of 30 kg/m2 or higher. (5) Those who are at risk of developing allergies related to the research. (6) Those whose daily alcohol consumption exceeds an average of 60 g/day of pure alcohol equivalent. (7) Those who are judged to be unsuitable as a subject based on the results of the lifestyle questionnaire. (8) Those whose physical measurements, physical test values, and clinical test values before the start of ingestion show significant deviations from the standard range. (9) Those who are currently participating in other clinical tests, or those who have not passed 3 months after participation in other clinical tests. (10) Those who plan to become pregnant or breastfeed during the study period. (11) Those who are likely to change their lifestyle during the study period (e.g., long trips, etc.). (12) Any other person who is judged as inappropriate as a subject by the Chief Medical Officer.

Related Information

• Primary Sponsor: EP Mediate Co., Ltd.
• Source(s) of Monetary Support: KOBAYASHI PHARMACEUTICAL CO., LTD.