Tokyo, May 8 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000061464) titled 'A study evaluating the effects of a test food on blood ketone levels and safety in healthy adult men' on May 7.
Study Type:
Interventional
Study Design:
Basic Design - Parallel
Randomization - Randomized
Blinding - Open -no one is blinded
Control - Placebo
Primary Sponsor:
Institute - EP Mediate Co., Ltd.
Condition:
Condition - Healthy adult
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - To assess the kinetics of blood ketone levels and the safety following a single administration of the test food in healthy adult men
Basic objectives2 - Safety,Efficacy
Intervention:
Interventions/Control_1 - Single dose of 200 mL of the test food
Interventions/Control_2 - Single dose of 400 mL of the test food
Eligibility:
Age-lower limit - 20
years-old
Gender - Male
Key inclusion criteria - (1) Healthy adult males aged >= 20 and < 40 years
(2) Subjects with a BMI of 18.5 kg/m2 or higher but less than 25.0 kg/m2 at the time of the baseline assessment
(3) Subjects judged to be healthy based on baseline assessment results
(4) Subjects who fully understand the purpose and content of the study and voluntarily agree to participate in the study
Key exclusion criteria - (1) Subjects receiving treatment with any therapeutic drug
(2) Subjects following diet and exercise therapy under a physician's supervision
(3) Subjects with a current serious illness
(4) Subjects with a history of gastrointestinal surgery (excluding appendectomy) or gastrointestinal disorders
(5) Subjects with a smoking habit
(6) Subjects regularly using medications, quasi-drugs, or health foods (e.g., FOSHU, foods with functional claims, supplements) three or more times weekly
(7) Subjects adhering to dietary restrictions such as low-carbohydrate, low-protein, or ketogenic diets
(8) Subjects with a history of food or drug allergies
(9) Subjects participating in other clinical studies, or who completed another clinical study within one month prior to enrollment
(10) Subjects who underwent blood sampling of more than 200 mL or 400 mL within one month prior to study start
(11) Subjects who work in shifts, work late at night, and have an irregular daily rhythm
(12) Subjects who tested positive for infection in screening performed upon admission for hospitalization
(13) Subjects who are judged to be unsuitable for participation in the study based on their responses to the lifestyle questionnaire
(14) Subjects deemed ineligible for participation based on baseline assessment results
(15) Subjects who are judged as unsuitable for the study by the principal investigator or the investigator for other reason
Target Size - 24
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2026 Year 04 Month 09 Day
Date of IRB - 2026 Year 04 Month 09 Day
Anticipated trial start date - 2026 Year 05 Month 08 Day
Last follow-up date - 2026 Year 06 Month 07 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000070337
Disclaimer: Curated by HT Syndication.
