Tokyo, July 12 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000058436) titled 'Study to confirm absorption of carotenoids in trial foods' on July 11.
Study Type:
Interventional
Study Design:
Basic Design - Cross-over
Randomization - Randomized
Blinding - Double blind -all involved are blinded
Control - Active
Primary Sponsor:
Institute - APO PLUS STATION CO., LTD.
Condition:
Condition - Healthy volunteers
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - To compare the absorption effectiveness of existing and new formulations in humans.
Basic objectives2 - Pharmacokinetics
Intervention:
Interventions/Control_1 - The trial food will be consumed once, followed by a washout period, then the control food will be consumed once.
Interventions/Control_2 - After consuming the control food once, a washout period will follow, and the test food will be consumed once.
Eligibility:
Age-lower limit - 20
years-old
Gender - Male and Female
Key inclusion criteria - 1) Japanese males and females aged 20 to under 60 at the time of informed consent.
2) Participants who with a BMI >=18.5 kg/m2 and <25kg/m2.
3) Participants who received a full explanation of the study and signed the informed consent form before study initiation.
Key exclusion criteria - 1) Participants with a history of serious illness or gastrointestinal surgery.
2) Participants with diseases affecting gastric emptying or digestion/absorption, or who regularly experience symptoms such as indigestion, constipation, or diarrhea.
3) Participants with abnormal kidney or liver function, blood pressure, or glucose/lipid metabolism.
4) Participants who regularly use medications (including Kampo), or quasi-drugs or supplements.
5) Participants who regularly consume health foods (e.g., FOSHU, foods with functional claims) that may affect the study and cannot discontinue them during the study period.
6) Participants who consume excessive amounts of alcohol.
7) Participants who Currently smoke or have smoked within the past year.
8) Participants planning to travel abroad during the study period.
9) Participant with irregular work hours or engaged in shift work.
10) Participants who may be unable to maintain their lifestyle due to dietary restrictions.
11) Participants with food allergies or those who may react to the trial or provided food.
12) Participants who are pregnant, breastfeeding, or planning to become pregnant during the study period.
13) Participants who joined another clinical trial within one month before consent or plan to join one during the study.
14) Participants deemed ineligible by the principal investigator.
Target Size - 20
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2025 Year 07 Month 11 Day
Date of IRB - 2025 Year 07 Month 11 Day
Anticipated trial start date - 2025 Year 07 Month 12 Day
Last follow-up date - 2025 Year 12 Month 31 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066770
Disclaimer: Curated by HT Syndication.
