UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034216 |
|---|---|
| Receipt number | R000039008 |
| Scientific Title | Randomized, placebo-controlled double-blind, comparative study of Ketonformula in healthy adult volunteers (repeated dose study) |
| Date of disclosure of the study information | 2018/11/01 |
| Last modified on | 2019/10/01 19:57:59 |
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Basic information
Public title
Randomized, placebo-controlled double-blind, comparative study of Ketonformula in healthy adult volunteers (repeated dose study)
Acronym
Repeated 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 (repeated dose study)
Scientific Title:Acronym
Repeated 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 repeated administration of Ketonformula in healthy adult volunteers
Basic objectives2
PK,PD
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Phase I
Assessment
Primary outcomes
plasma concentration of ketone bodies (acetoacetic acid, 3-hydroxybutyrate)
Key secondary outcomes
plasma concentration of acetoacetic acid
plasma concentration of 3-hydroxybutyrate
plasma concentration of medium chain fatty acids
Acetone concentration in human breath
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Low carbohydrate diet and the 50g placebo formula,3 times per day
Interventions/Control_2
Low carbohydrate diet and the 50g Ketonformula,3 times per day
Interventions/Control_3
Normal diet, 3 times per day
Interventions/Control_4
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 BMI is 18.5 to 25.0
4) Subjects whose height is 165 cm to 175 cm
Key exclusion criteria
1) Subjects having a smoking habit
2) Subjects receiving drug treatment
3) Subjects whose blood test value are not within the standard values
4) Subjects with gastrointestinal complications
5) Food allergies
6) Lactose intolerance
7) Subjects undergoing carbohydrate restriction or ketogenic diet
8) Subjects who were collected over 400 mL blood within 3 months
9) Subjects who participated another clinical trials within 3 months
10) Any other person whom the principal investigator has determined to be unsuitable as a participant of the study.
Target sample size
16
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
Department of Advanced Hybrid Medicine 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
Japan
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
大阪大学医学部附属病院（大阪府）
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 11 | Month | 01 | 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 | 10 | Month | 19 | Day |
Date of IRB
| 2018 | Year | 10 | Month | 26 | Day |
Anticipated trial start date
| 2018 | Year | 11 | Month | 02 | Day |
Last follow-up date
| 2018 | Year | 11 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 09 | Month | 20 | Day |
Last modified on
| 2019 | Year | 10 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039008
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
