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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000034216
Receipt No. 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 2018/09/20

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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
Middle name
Last name Keisuke Hagihara
Organization Graduate School of Medicine, Osaka University
Division name Department of Advanced Hybrid Medicine
Zip code
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
Middle name
Last name Keisuke Hagihara
Organization Graduate School of Medicine, Osaka University
Division name Department of Advanced Hybrid Medicine
Zip code
Address 2-2 Yamadaoka, Suita, Osaka 565-0871
TEL 06-6210-8349
Homepage URL
Email hagihara.keisuke@gmail.com

Sponsor
Institute Department of Advanced Hybrid Medicine 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 Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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 Preinitiation
Date of protocol fixation
2018 Year 10 Month 19 Day
Date of IRB
Anticipated trial start date
2018 Year 11 Month 02 Day
Last follow-up date
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
2018 Year 09 Month 20 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039008

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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