Comparative study of human absorption of Q10 formulation -1 (NO fasting condition)

UMIN ID: UMIN000056184

Registered date:18/11/2024

Basic Information

• Recruitment status: Pending
• Health condition(s) or Problem(s) studied: None
• Date of first enrollment: 2024/11/19
• Target sample size: 6
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

Single intake of test food A, washout, single intake of test food B
Single intake of test food B, washout, single intake of test food A

Outcome(s)

• Primary Outcome: Evaluation of total CoQ10 concentration in plasma
• Secondary Outcome: Evaluation of reduced CoQ10 concentration, oxidized CoQ10 concentration, and reduced/total CoQ10 ratio in plasma

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: 40years-old
• Gender: Male
• Exclude criteria: 1)Subjects who have systolic blood pressure <90 mmHg 2)Subjects who donated their blood components and/or whole blood 200mL within the past 4 weeks 3)Subjects who donated their whole blood 400mL within the past 12 weeks 4)Subjects being collected in total of their blood 1,200mL within the past 12 months and in this research 5)Subjects who participated in other clinical studies in the past 4 weeks or who are scheduled to participate in another study during the study period 6)Subjects who meet any of the following: a)Suffering from heart, liver, or kidney disease (including complications of other diseases) b)Having a history of cardiovascular disease c)Diabetes d)Allergic to the test food e)Subjects with a positive or suspected positive test for infectious diseases 7)Subjects who are under treatment at the time of obtaining consent to participate in the study 8)Subjects who have history of surgery on gastrointestinal part such as gastrectomy, gastrointestinal suture and intestinal resection 9)Subjects who have some kind of food allergy 10)Subjects who have experienced sickness due to blood collection 11)Subjects who have difficulty drawing blood from the peripheral vein 12)Heavy drinker (over 40g alcohol/day) 13)Subjects who quit smoking for less than 6 months or smokers 14)Subjects whose eating habits are extremely irregular 15)Subjects who are shift workers and night workers 16)Subjects who have used medicines within 1 week of ingestion of the test food 17)Subjects who use oral medication or supplements which may affect this study or ingested within 1 month 18)Subjects judged as unsuitable for this study by the principal investigator

Related Information

• Primary Sponsor: KANEKA CORPORATION
• Source(s) of Monetary Support: KANEKA CORPORATION