Tokyo, March 1 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000053769) titled 'Exploratory study of test food on postprandial serum metabolite level' on March 1.
Study Type:
Interventional
Study Design:
Basic Design - Single arm
Randomization - Non-randomized
Blinding - Open -no one is blinded
Control - Uncontrolled
Primary Sponsor:
Institute - Meiji Co., Ltd.
Condition:
Condition - Healthy adult
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - We evaluate the transfer metabolites into the blood by eating test food
Basic objectives2 - Bio-equivalence
Intervention:
Interventions/Control_1 - Single ingestion of test food
Eligibility:
Age-lower limit - 20
years-old
Gender - Male
Key inclusion criteria - (1) Male subjects ranging age from 20 to 59
(2) Subjects who can ingest 100g test food
(3) Subjects who can give informed consent to participate in this study, after being provided with an explanation of the protocol detail.
Key exclusion criteria - (1) Subjects who are now under medication treatment or will take medication on the test day
(2) Subjects who are now under other clinical trials with some kind of medicine/food, or participated in those tests within four weeks before this trial, or planning to join those after the consent.
(3) Subjects who regularly consume large amount of alcohol
(4) Subjects with a history of gastrointestinal surgery
(5) Subjects who have been diagnosed with gastroptosis or esophagitis
(6) Subjects who have tested positive for HBs antigen, HCV antibody, HIV, or syphilis in the past
(7) Subjects with current and/or previous medical history of serious diseases in heart, liver, kidney, digestive system, etc.
(8) Subjects whose protein intake is restricted under the supervision of a doctor
(9) Subjects who are aware of lactose intolerance
(10) Subjects who are allergic to foods or pharmaceuticals.
(11) Subjects who donated their blood components and/or whole blood (200 mL) within a month prior to this trial.
(12) Subjects who donated their whole blood (400 mL) within the last three months prior to this trial.
(13) Subjects who will be collected in total of their blood (1200 mL) within the last twelve months, after adding the blood amounts planning to be sampled in this trial.
(14) Others who have been determined as ineligible for participation, judging from the principal/sub investigator's opinions.
Target Size - 12
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2024 Year 02 Month 19 Day
Date of IRB - 2024 Year 02 Month 16 Day
Anticipated trial start date - 2024 Year 03 Month 06 Day
Last follow-up date - 2024 Year 03 Month 31 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000061363
Disclaimer: Curated by HT Syndication.
