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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000032634
Receipt No. 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

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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
Email 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
Email hagihara.keisuke@gmail.com

Sponsor
Institute Graduate School of Medicine, Osaka University
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037162

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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