UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000061464 |
|---|---|
| Receipt number | R000070337 |
| Scientific Title | A study evaluating the effects of a test food on blood ketone levels and safety in healthy adult men |
| Date of disclosure of the study information | 2026/05/07 |
| Last modified on | 2026/05/08 14:11:37 |
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Basic information
Public title
A study evaluating the effects of a test food on blood ketone levels and safety in healthy adult men
Acronym
Ketone body dynamics and safety of after single-dose intake of test food (healthy men)
Scientific Title
A study evaluating the effects of a test food on blood ketone levels and safety in healthy adult men
Scientific Title:Acronym
Ketone body dynamics and safety of after single-dose intake of test food (healthy men)
Region
| Japan |
Condition
Condition
Healthy adult
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
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
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
ketone bodies fractionation
Key secondary outcomes
urinary ketone bodies, blood glucose, venous blood gas analysis (pH, PO2, PCO2, HCO3-, BE)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
4
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Single dose of 200 mL of the test food
Interventions/Control_2
Single dose of 400 mL of the test food
Interventions/Control_3
Single dose of 600 mL of the test food
Interventions/Control_4
Single dose of 200 mL of the placebo food
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| 40 | 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 sample size
24
Research contact person
Name of lead principal investigator
| 1st name | Toru |
| Middle name | |
| Last name | Nakamura |
Organization
EN Otsuka Pharmaceutical Co., Ltd.
Division name
Clinical Development Department
Zip code
101-0052
Address
6th Floor, Nikko Kanda Building, 1-1 Kanda Ogawamachi Chiyoda-ku, Tokyo,
TEL
03-6632-3516
nakamura.toru@otsuka.jp
Public contact
Name of contact person
| 1st name | Saki |
| Middle name | |
| Last name | Fukuchi |
Organization
EP Mediate Co., Ltd.
Division name
Development Department Trial Planning Section
Zip code
162-0814
Address
Acropolis Tokyo, 6-29 Shinogawacho, Shinjuku, Tokyo,
TEL
090-1400-7556
Homepage URL
fukuchi.saki473@eps.co.jp
Sponsor or person
Institute
EP Mediate Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
EN Otsuka Pharmaceutical Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Medical Station Clinic Research Ethics Committee
Address
3-12-8, Takaban, Meguro-ku, Tokyo
Tel
03-6452-2712
epmd_fd-erb@eps.co.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
医療法人社団成守会 成守会クリニック（東京都）
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 05 | Month | 07 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Open public recruiting
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 |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2026 | Year | 05 | Month | 07 | Day |
Last modified on
| 2026 | Year | 05 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000070337
