UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037787 |
|---|---|
| Receipt number | R000043088 |
| Scientific Title | The effect of ketone ester intake on the oral glucose tolerance test |
| Date of disclosure of the study information | 2019/08/24 |
| Last modified on | 2020/09/01 19:44:48 |
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Basic information
Public title
The effect of ketone ester intake on the oral glucose tolerance test
Acronym
The effect of ketone ester intake on the oral glucose tolerance test
Scientific Title
The effect of ketone ester intake on the oral glucose tolerance test
Scientific Title:Acronym
The effect of ketone ester 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 effect of ketone ester on glucose metabolism in Japanese adults with impaired glucose tolerance
Basic objectives2
Others
Basic objectives -Others
Metabolic changes after ketone ester
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The changes of blood glucose after ketone ester during oral glucose tolerance test (area under the curve)
Key secondary outcomes
After ketone ester during oral glucose tolerance test
- beta hydroxybutyrate
- acetoacetic acid
- total ketone
- insulin
- C-peptide
- glucagon
- free fatty acid
- incretin hormone
- Insulinogenic Index
- Matsuda Index
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -investigator(s) and assessor(s) are 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
ketone ester
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 and Female
Key inclusion criteria
BMI: 18.5 to 25.0 kg/m2
Persons who gained document consent by the
patients' 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 virus
9, history of hepatitis 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 attempts 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 (ex, for MRI)
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Tamura |
| Middle name | |
| Last name | Yoshifumi |
Organization
Juntendo University
Division name
Department of Metabolism & Endocrinology, Sportology center, Faculty of International Liberal Arts. Area of Global Health Service
Zip code
113-8421
Address
Bunkyo-ku Hongo 2-1-1
TEL
03-3813-3111
ys-tamur@juntendo.ac.jp
Public contact
Name of contact person
| 1st name | Nakagata |
| Middle name | |
| Last name | Takashi |
Organization
Juntendo University
Division name
Sportology center
Zip code
113-8421
Address
Bunkyo-ku Hongo 2-1-1
TEL
03-3813-3111
Homepage URL
tanakaga@juntendo.ac.jp
Sponsor or person
Institute
Sportology center, Juntendo University
Institute
Department
Personal name
Funding Source
Organization
The Ministry of Education, Culture, Sports, Science and Technology
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
Bunkyo-ku, Hongo 2-1-1
Tel
03-3813-3176
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
| 2019 | Year | 08 | Month | 24 | 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
| 2018 | Year | 06 | Month | 01 | Day |
Date of IRB
| 2018 | Year | 06 | Month | 28 | Day |
Anticipated trial start date
| 2019 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 07 | 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
| 2019 | Year | 08 | Month | 24 | Day |
Last modified on
| 2020 | Year | 09 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043088
