Tokyo, Oct. 16 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000059419) titled 'The effect of taking Brazilian green propolis with boiled warm water on its pharmacokinetics in healthy volunteers' on Oct. 15.
Study Type:
Interventional
Study Design:
Basic Design - Single arm
Randomization - Non-randomized
Blinding - Open -no one is blinded
Control - Self control
Primary Sponsor:
Institute - Yamada Bee Company, Inc.
Condition:
Condition - Adult
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - To investigate the effect of taking Brazilian green propolis with boiled warm water on its pharmacokinetics.
Basic objectives2 - Bio-availability
Intervention:
Interventions/Control_1 - Blood samples are collected up to 8 hour after ingestion of Brazilian green propolis (360 mg) with water (room temperature) or boiled hot water (50 degree Celsius). The experimental periods are separated by at least 72 hours as a washout period.
Eligibility:
Age-lower limit - 20
years-old
=
Gender - Male and Female
Key inclusion criteria - 1. Healthy Japanese men and women aged between 20 and 60 at the time of informed consent.
2. BMI:18.5 - 25.0
Key exclusion criteria - 1. Participants who have history of food allergies.
2. Participants who have history of asthma.
3. Participants in pregnancy or in nursing.
4. Participants who had participated in other clinical trial within 12 weeks.
5. Participants who have a history of the surgery considerable in the gastrointestinal tract site, for example, gastrectomy, gastrointestinal suturing, intestinal resection and so on.
6. Participants with a current or history of serious illness, such as diabetes, liver disease, kidney diseases, heart diseases, and more.
7. Participants who have taken medication treatment.
8. Participants who can not refrain from consuming for specified foods from dinner on the night before the test until the end of the test.
9. Participants who can not quit smoking from dinner on the night before the test until the end of the test.
10. Participants who are unable to consume the test food as instructed or remain at rest until the completion of the study.
11. Participants who can not prohibit intake of foods, medicines, and supplements containing propolis or flavonoid at least one week prior to the start of this study.
12. Participants who can not continue regular life.
13. Participants who are night workers of shift workers.
14. Participants who have taken the blood sampling either 200 mL within 4 weeks or 400 mL within 3 months.
15. Participants who are heavy drinker (>500 mL beer per day).
16. Participants who are smoking more than 20 cigarettes per day.
17. Participants who are judged as unsuitable for the current in this study by the study director.
Target Size - 8
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2025 Year 09 Month 30 Day
Anticipated trial start date - 2025 Year 10 Month 16 Day
Last follow-up date - 2025 Year 10 Month 21 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067954
Disclaimer: Curated by HT Syndication.
