UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032634 |
|---|---|
| Receipt number | R000037162 |
| Scientific Title | Randomized, placebo-controlled double-blind, comparative study of Ketonformula in healthy adult volunteers (single dose study) |
| Date of disclosure of the study information | 2018/06/30 |
| Last modified on | 2019/11/18 16:17:27 |
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Basic information
Public title
Randomized, placebo-controlled double-blind, comparative study of Ketonformula in healthy adult volunteers (single dose study)
Acronym
Single dose study of Ketonformula for standardization of cancer ketogenic diet therapy
Scientific Title
Randomized, placebo-controlled double-blind, comparative study of Ketonformula in healthy adult volunteers (single dose study)
Scientific Title:Acronym
Single dose study of Ketonformula for standardization of cancer ketogenic diet therapy
Region
| Japan |
Condition
Condition
Healthy adult
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To elucidate the pharmacokinetics of blood ketone bodies when single administration of Ketonformula in healthy adult volunteers
Basic objectives2
PK,PD
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
plasma concentration of ketone bodies (acetoacetic acid, 3-hydroxybutyrate)
Key secondary outcomes
Acetone concentration in breath
plasma concentration of medium chain fatty acids
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are 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
A single serving of the 50g placebo formula
Interventions/Control_2
A single serving of the 50g placebo formula and the 25g Ketonformula
Interventions/Control_3
A single serving of the 25g placebo formula and the 50g Ketonformula
Interventions/Control_4
A single serving of the 75g Ketonformula
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) Subjects who have given written informed consent
2) Healthy males aged 20 to 40 years old
3) Subjects whose blood test value and urine test value are within the normal range
4) Subjects whose BMI is 18.5 to 25
Key exclusion criteria
1) Subjects having a smoking habit
2) Subjects receiving drug treatment
3) Subjects whose blood test value and urine test value are out of the normal range
4) Subjects with gastrointestinal complications
5) Subjects with allergies to milk, soybean, or pork
6) Subjects with lactose intolerance
7) Subjects undergoing carbohydrate restriction or ketogenic diet
8) Any other person whom the principal investigator has determined to be unsuitable as a participant of the study.
Target sample size
24
Research contact person
Name of lead principal investigator
| 1st name | Keisuke |
| Middle name | |
| Last name | Hagihara |
Organization
Graduate School of Medicine, Osaka University
Division name
Department of Advanced Hybrid Medicine
Zip code
565-0871
Address
2-2 Yamadaoka, Suita, Osaka 565-0871
TEL
06-6210-8349
hagihara.keisuke@gmail.com
Public contact
Name of contact person
| 1st name | Keisuke |
| Middle name | |
| Last name | Hagihara |
Organization
Graduate School of Medicine, Osaka University
Division name
Department of Advanced Hybrid Medicine
Zip code
565-0871
Address
2-2 Yamadaoka, Suita, Osaka 565-0871
TEL
06-6210-8349
Homepage URL
hagihara.keisuke@gmail.com
Sponsor or person
Institute
Graduate School of Medicine, Osaka University
Institute
Department
Personal name
Funding Source
Organization
Meiji, Co., Ltd., Meiji Seika Pharma, Co., Ltd., The Nisshin OilliO Group, Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Osaka University Clinical Research Review Committee
Address
2-15, Yamadaoka, Suita, Osaka, Japan
Tel
06-6210-8290
rinri@hp-crc.med.osaka-u.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
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 06 | Month | 30 | 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
No longer recruiting
Date of protocol fixation
| 2018 | Year | 06 | Month | 27 | Day |
Date of IRB
| 2018 | Year | 06 | Month | 27 | Day |
Anticipated trial start date
| 2018 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2018 | Year | 08 | Month | 11 | Day |
Date of closure to data entry
| 2018 | Year | 09 | Month | 06 | Day |
Date trial data considered complete
| 2019 | Year | 02 | Month | 06 | Day |
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 05 | Month | 18 | Day |
Last modified on
| 2019 | Year | 11 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037162
