UMIN-CTR Clinical Trial

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