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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000034088
Receipt No. R000038776
Scientific Title The effect of exogenous ketone salt supplement intake on the oral glucose tolerance test
Date of disclosure of the study information 2018/09/11
Last modified on 2019/09/06

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Basic information
Public title The effect of exogenous ketone salt supplement intake on the oral glucose tolerance test
Acronym The effect of exogenous ketone salt supplement intake on the oral glucose tolerance test
Scientific Title The effect of exogenous ketone salt supplement intake on the oral glucose tolerance test
Scientific Title:Acronym The effect of exogenous ketone salt supplement intake on the oral glucose tolerance test
Region
Japan

Condition
Condition Lifestyle-related disease
Classification by specialty
Medicine in general Endocrinology and Metabolism Adult
Classification by malignancy Others
Genomic information YES

Objectives
Narrative objectives1 To examine the effects of exogenous ketone salt supplement on glucose metabolism in healthy non-obese Japanese men
Basic objectives2 Others
Basic objectives -Others Metabolic changes after exogenous ketone salt supplement
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The changes of blood glucose after exogenous ketone salt supplement during oral glucose tolerance test(area under the curve)
Key secondary outcomes After exogenous ketone supplement during oral glucose tolerance test
-beta hydroxybutyrate
-acetoacetic acid
-total ketone
-insulin
-free fatty acid
-glucagon
-incretin hormone
-C peptide
-Matsuda Index

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Food
Interventions/Control_1 beta-hydroxybutyrate salt supplement
Interventions/Control_2 single
Interventions/Control_3
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
65 years-old >=
Gender Male
Key inclusion criteria BMI range: 18.5-25 kg/m2
Persons who gained document consent by the patient's free intention after having sufficient explanation for participation in this study and having sufficient understanding
Key exclusion criteria 1,history of diabetes
2,history of food allergy
3,history of drug hypersensitivity
4,habitual drinker(ethanol=>30g/day)
5,history of hypertension or dyslipidemia
6,history of digestive system disease
7,history of digestive surgical operation
8,history of hepatitis B virus or hepatitis C viru
9,history of heart disease
10,liver
dysfunction(AST,ALT:=>51U/L, gamma-GTP=>101U/L) or renal dysfunction(urinary protein2+,uric blood2+,creatinine level=>1.3mg/dl)
11,Recent weight changes or attemps to lose weight(3kg weight gain or loss,within last 1 month)
12,low-carbohydrate diet(carbohydrate under 150g/day)
13,current smoker
14,subjects judged unsuitable to the study from staff(for example for MRI)
Target sample size 15

Research contact person
Name of lead principal investigator
1st name Yoshifumi
Middle name
Last name Tamura
Organization Juntendo University
Division name Department of Endocrinology and Metabolism, Sportology center, Faculty of International Liberal Arts. Area of Global Health Service
Zip code 113-8421
Address 2-1-1, Hongo, Bunkyo-ku,Tokyo 113-8421 JAPAN
TEL 03-3813-3111
Email takashi.nakagata@gmail.com

Public contact
Name of contact person
1st name Takashi
Middle name
Last name Nakagata
Organization Juntendo University
Division name Sportology Center
Zip code 113-8421
Address 2-1-1, Hongo, Bunkyo-ku,Tokyo 113-8421 JAPAN
TEL 03-3813-3111
Homepage URL
Email takashi.nakagata@gmail.com

Sponsor
Institute Sportology Center, Juntendo University
Institute
Department

Funding Source
Organization The Ministry of Education, Culture, Sports, Science and Techonology
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization Juntendo university
Address 2-1-1, Hongo, Bunkyo-ku,Tokyo 113-8421 JAPAN
Tel 03-3813-3111
Email rinri@juntendo.ac.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 09 Month 11 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 Completed
Date of protocol fixation
2017 Year 10 Month 02 Day
Date of IRB
2017 Year 08 Month 03 Day
Anticipated trial start date
2018 Year 01 Month 15 Day
Last follow-up date
2018 Year 12 Month 31 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 11 Day
Last modified on
2019 Year 09 Month 06 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038776

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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