Study to confirm the absorption enhancing effect of carotenoids by lactic acid bacteria and their metabolites

UMIN ID: UMIN000055011

Registered date:11/09/2024

Basic Information

• Recruitment status: Pending
• Health condition(s) or Problem(s) studied: Healthy subjects
• Date of first enrollment: 2024/08/29
• Target sample size: 40
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

Subjects receive a single dose of carotenoids + the placebo foods. After the washout period (13 days or more), subjects receive a single dose of carotenoids + the active foods.
Subjects receive a single dose of carotenoids + the active foods. After the washout period (13 days or more), subjects receive a single dose of carotenoids + the placebo foods.

Outcome(s)

• Primary Outcome: Plasma beta-carotene concentration
• Secondary Outcome: Plasma concentrations of other carotenoids and their metabolites.

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: 35years-old
• Gender: Male
• Exclude criteria: 1) Subjects who routinely use pharmaceuticals, quasi-drugs, dietary supplement, and consume food for specified health uses, supplements containing carotenoids more than two days per week 2) Subjects who have chronic diseases necessitating treatments and/or medications 3) Subjects who have abnormal lipid metabolism, glucose metabolism, liver function, or kidney function 4) Subjects who received digestive surgical procedures 5) Habitual smokers 6) Subjects who participate in other clinical trials within the past month or have plans to participate in other clinical trials during this study period 7) Subjects who have food allergy 8) Subjects who is conscious of being prone to diarrhea from dairy products 9) Subjects who donate 200 mL of blood within a month, or 400 mL of blood within three month 10) Subjects who determine ineligible by the principal investigator or sub-investigator

Related Information

• Primary Sponsor: Meiji Co., Ltd.
• Secondary Sponsor: Meiji Holdings Co., Ltd., CPCC Company Limited, Chiyoda Paramedical Care Clinic
• Source(s) of Monetary Support: Meiji Co., Ltd.