Tokyo, Oct. 8 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000063206) titled 'Comparative study of human absorption of Q10 formulation -6 (NO fasting condition)' on Oct. 8.
Study Type:
Interventional
Study Design:
Basic Design - Cross-over
Randomization - Randomized
Blinding - Open -no one is blinded
Control - Active
Primary Sponsor:
Institute - KANEKA CORPORATION
Condition:
Condition - None
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - To compare the absorbability of three types of Q10 formulations in humans in NO fasting condition.
Basic objectives2 - Bio-availability
Intervention:
Interventions/Control_1 - Single intake of test food A , Washout , Single intake of test food B , Washout , Single intake of test food C
Interventions/Control_2 - Single intake of test food B , Washout , Single intake of test food C , Washout , Single intake of test food A
Eligibility:
Age-lower limit - 40
years-old
Gender - Male and Female
Key inclusion criteria - 1) Healthy males aged of 40-59 years and postmenopausal females aged 50-59 years at the time of informed consent.
2) Subjects whose BMI18.5 kg/m2 <= and <25.0 kg/m2
3) Subjects who can visit the clinic on the scheduled visit date
4) Subjects who agreed in writing with sufficient understanding of the purpose and contents of this study
Key exclusion criteria - 1) Subjects who were unable to consume their entire breakfast within the designated time
2) Subjects who have systolic blood pressure <90 mmHg
3) Subjects who donated their blood components and/or whole blood 200mL within the past 4 weeks
4) Men who donated their whole blood 400mL within the past 12 weeks
5) Women who donated their whole blood 400mL within the past 16 weeks
6) Men being collected in total of their blood 1,200mL within the past 12 months and in this research
7) Women being collected in total of their blood 800mL within the past 12 months and in this research
8) 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
9) 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
10) Subjects who are under treatment at the time of obtaining consent to participate in the study
11) Subjects who have history of surgery on gastrointestinal part such as gastrectomy, gastrointestinal suture and intestinal resection
12) Subjects who have some kind of food allergy
13) Subjects who have experienced sickness due to blood collection
14) Subjects who have difficulty drawing blood from the peripheral vein
15) Heavy drinker (over 40g alcohol/day)
16) Subjects who quit smoking for less than 6 months or smokers
17) Subjects whose eating habits are extremely irregular
18) Subjects who are shift workers and night workers
19) Subjects who use oral medication or supplements which may affect this study or habitually consumed within the past month
20) Subjects judged as unsuitable for this study by the principal investigator
Target Size - 18
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2026 Year 09 Month 29 Day
Date of IRB - 2026 Year 10 Month 05 Day
Anticipated trial start date - 2026 Year 10 Month 09 Day
Last follow-up date - 2026 Year 12 Month 04 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072336
Disclaimer: Curated by HT Syndication.
