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UMIN-CTR Clinical Trial |
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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 |
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 |
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Condition | ||||
Condition | Lifestyle-related disease | |||
Classification by specialty |
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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 |
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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 |
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Age-upper limit |
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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 |
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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) |
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Target sample size | 15 |
Research contact person | |||||||
Name of lead principal investigator |
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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 | ||||||
takashi.nakagata@gmail.com |
Public contact | |||||||
Name of contact person |
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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 | |||||||
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 |
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 |
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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 |
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Date of IRB |
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Anticipated trial start date |
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Last follow-up date |
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Date of closure to data entry | |||||||
Date trial data considered complete | |||||||
Date analysis concluded |
Other | |
Other related information |
Management information | |||||||
Registered date |
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Last modified on |
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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 |